WO2017211296A1

WO2017211296A1 - A urinary incontinence management system

Info

Publication number: WO2017211296A1
Application number: PCT/CN2017/087447
Authority: WO
Inventors: Tat Ming Wu
Original assignee: Gen Shun Electronic And Technology Co., Limited
Priority date: 2016-06-07
Filing date: 2017-06-07
Publication date: 2017-12-14
Also published as: CN108495684A; WO2017210870A1

Abstract

A device (100) for treating urinary incontinence comprising a housing (101) having a periphery, a main control unit (303) provided inside the housing (101), a motor (300) stowed inside the housing (101), a pair of electrodes (102A, 102B) provided on the periphery of the housing (101), wherein the main control unit (303) comprises a wireless communication module, a vibration module/circuit (301) electrically connected to the motor (300) and an electrical stimulation module/circuit (302) electrically connected to the pair of electrodes (102A, 102B) for generating vibration and electrical stimulation.

Description

A URINARY INCONTINENCE MANAGEMENT SYSTEM

TECHNICAL FIELD

The present invention relates to a urinary incontinence management system including， for example， a urinary incontinence treatment device for use with a mobile computer device such as particularly， but not exclusively， a mobile phone installed with an application.

DESCRIPTION OF THE RELATED ART

Urinary incontinence is a common and often embarrassing problem. The severity ranges from occasionally leaking urine when you cough or sneeze to having an urge too sudden and strong to permit reaching a toilet in time. For most people， strengthening exercises， simple lifestyle change or medical treatment can ease discomfort or at least lessen the urinary incontinence.

There are different types of urinary incontinence which include stress incontinence where urine leaks when pressure is exerted on the bladder by coughing， sneezing， laughing， exercising or lifting heavy item； urge incontinence where there is a sudden， intense urge to urinate followed by an involuntary loss of urine that may be caused by a minor condition， such as infection， or a more severe condition such as neurologic disorder or diabetes； overflow incontinence in which the patient experiences frequent or constant dribbling of urine due to a bladder that fails to empty completely； functional incontinence is a physical or mental impairment that keeps a patient from making it to the toilet in time； and mixed incontinence which is where a patient experiences more than one type of the aforementioned.

Treatment for urinary incontinence depends on the type of incontinence， its severity and the underlying cause. A combination of treatments may be needed. It is common to try least invasive treatments first and move on to other options. The less invasive treatments include behavioral techniques such as bladder training to delay urination， double voiding to help empty bladder more completely， apply scheduled toilet trips and fluid /diet management to reduce liquid consumption. Pelvic floor muscle exercises (Kegel exercise) are exercises frequently use to strengthen the muscles that help control urination and are especially effective for stress incontinence but may not help urge incontinence. Electrical stimulation may be recommended to stimulate and strengthen pelvic floor muscles for treating both stress incontinence and urge incontinence. Multiple treatments over several months are common. It would take a lot of effort to travel to and from a clinic for such treatment.

Vibration exercise has been developed as a new modality in the field of physiotherapy. It has a positive effect on muscle strength and rate of force. Vibration is proven to be useful as a treatment. The Galileo machine is a unique device for applying whole-body vibration but is relative space occupying and expansive.

The invention seeks to eliminate or at least to mitigate such shortcomings by providing an improved urinary incontinence management system.

SUMMARY OF THE INVENTION

In a first aspect of the invention there is provided a device for treating urinary incontinence comprising a housing having a periphery， a main control unit provided inside the housing， a motor stowed inside the housing， a pair of electrodes provided on the periphery of the housing， The device as claimed in claim 1， wherein the main control unit is an integrated circuit containing the wireless communication module， the vibration module/circuit and the electrical stimulation module/circuit connected in parallel with the wireless communication module in the integrated circuit； preferably， the integrated circuit is adapted to receive instructions through a wireless communication and selectively provide instructions to one of the vibration module/circuit and the electrical stimulation module/circuit； more preferably， the wireless communication module is a Bluetooth module； Yet more preferably， the housing includes a battery as a power source； it is preferable that the battery comprises a rechargeable battery； advantageously， the housing comprises first portion on which the pair of electrodes are provided and a second portion having a control platform.

In a second aspect of the invention there is provided a urinary incontinence management system comprising the device as claimed in any one of claims 1 to 6 and a storage box which includes a housing defining a space for containing the device， wherein the housing includes a power inlet and a power outlet； preferably， the housing includes a power bank in electrical connection with the power inlet； more preferably， the power bank puts energy into the battery in the device by way of induction； it is preferable that the invention further comprises a mobile controller in wireless communication with the device； advantageously， the mobile controller comprises a mobile computer device.

In a third aspect of the invention， there is provided a method of managing urinary incontinence comprising the steps of providing a device having a main control unit with a wireless communication module， a vibration module/circuit electrically connected to the motor and an electrical stimulation module/circuit electrically connected to the pair of electrodes for generating vibration and electrical stimulation， providing a mobile controller having a wireless communication module， permitting pairing of the device and the mobile controller through their respective wireless communication module， permitting establishment of wireless communication between the device and the mobile controller after the pairing of the device and the mobile controller， providing first and second options of stimulation on the mobile controller for selective actuation by a user， and instructing the device， through an established wireless communication， to perform first or second function which corresponding to and based on the first or second option being selectively actuated； it is preferable that the method comprises the step of generating a first level interface on the mobile controller； preferably， the first level interface includes a connection key being generated together with the first level interface； it is advantageous that the method further comprises the step of establishing wireless communication between the device and the mobile controller by actuating the connection key on the mobile controller； it is preferable that the method further comprises the step of providing a core access key on the first level interface； preferably， it further comprises the step of generating a second level interface by actuation of the core access key； advantageously， the first level interface includes two or more core access keys correspond to two or more respective second level interfaces， actuation of one of the two or more core access key results in generation of a corresponding second level interface for performing a specific function； preferably， the method further comprises the step of generating a functional access key on the second level interface； more preferably， the method further comprises the step of generating a third level interface by actuation of the functional access key on the second level interface； advantageously， the method further comprises the step of generating two or more core access keys on the second level interface， the two or more core access keys correspond to two or more second level interfaces respectively； yet more preferably， it comprises the step of generating a corresponding second level interface by actuation of one of the two or mnore core access keys， it is preferable that the method comprises the step of generating a functional access key on the third level interface； it is preferable that the method further comprises the step of generating a fourth level interface by actuation of the functional access key on the third level interface； preferably， the method comprises the step of generating a core access key on the third level interface， which upon actuation generates a second level interface that replaces the third level interface； more preferably， the step of generating a core access key on the fourth level interface， which upon actuation generates a second level interface that replaces the fourth level interface； yet more preferably， the method further comprises the step of providing a reminder interface as a second level interface and generating a reminder in a human perceivable form based on information entered into the mobile controller through the reminder interface.

In a preferred embodiment the reminder includes a series of consecutive reminders generated periodically； preferably the method includes a step of suspending at least one reminder in the series of consecutive reminders by generating a suspension instruction； preferably， the functional key comprises an evaluation key which upon actuation generates a fillable evaluation questionnaire in a third level interface for self-assessment by a user； yet more preferably， the functional key comprises a report key which upon actuation generates a medical report in a third level interface； it is preferable that the medical comprises information of a previous treatment and results obtained from completion of the fillable evaluation questionnaire； more preferably， the functional key comprises an electrical stimulation key and a vibration stimulation key which upon actuation provides a first tier treatment instructions and prompts the mobile controller to generate a third level interface； advantageously， the method further comprises the step of generating two or more functional keys in the third level interface which upon actuation provides a second tier treatment instructions and prompts the mobile controller to generate a fourth level interface.

It is preferable that the second tier treatment instructions is more specific than the first tier treatment instructions； each of the two or more functional keys correspond to a specific and different mode of electrical stimulation for treating a specific type of urinary incontinence； advantageously， each of the two or more functional keys correspond to a specific and different mode of vibration stimulation； yet more advantageously， the functional keys are subdivided into first and second functional keys， instructions provided by actuation of a second functional key is more specific than instructions provided by actuation of a first functional key； it is preferable that the second functional key is assigned for adjustment of vibration intensity； and the method further comprises the step of actuating the first functional key to prompt the device in generating vibration stimulation which functions as an indicator to the user for taking a specific action； in a further embodiment， the method further comprises the step of generating and presenting a list of medical physician information， wherein each medical physician information constitute a key actuable by a user for establishing contact with the medical physician； and/or the step of generating and presenting a third level interface which contain specific information of one medical physician and includes functional key for establishing contact with said one medical physician； preferably， the second level interface comprises a diary interface which contains historical information of a conducted treatment； more preferably， the diary interface comprises indicator distinguishing a fully completed treatment from a partially completed treatment； the fourth level interface comprises any one of a group containing a game interface for entertaining a user， a， audio playing interface for music enjoyment， a countdown interface showing specific treatment mode and status and a self-evaluation result interface.

BRIEF DESCRIPTION OF DRAWINGS

The invention will now be more particularly described， by way of example only， with reference to the accompanying drawings， in which：

Figure 1A is a drawing showing a front view of a device in accordance with a first aspect of the invention；

Figure 1B is a drawing of a storage box in accordance with a second aspect of the invention for containing the device in Figure 1A；

Figure 2 is a functional block diagram showing the basic functions of the device；

Figures 3A to 3C are a zero level interfaces of an application on a mobile computer device in accordance with a third aspect of the invention for controlling the device in Figure 1A；

Figure 3D is a first level interface of an application on the mobile computer device in accordance with a third aspect of the invention；

Figure 4A is a second level interface of an application on the mobile computer device for selection of treatment mode to be performed by the device in Figure 1A， the treatment modes available for selection includes STIM and Vibration；

Figure 4B is a third level interface of an application on the mobile computer device after selection of STIM treatment mode， the interface permits selection of a condition of a patient to be treated by the device in Figure 1A；

Figure 4C is a fourth interface of an application on the mobile computer device after selection of the condition of the patient to be treated by the device in Figure 4B；

Figure 4D is a third level interface of an application on the mobile computer device after selection of vibration treatment mode， the interface permits selection of a preferred mode of treatment；

Figure 4E is a fourth interface of an application on the mobile computer device after selection of a preferred mode of treatment in Figure 4C；

Figure 5A is a second level interface on the mobile computer device in the application after selection of an evaluation mode， which offers self-assessment evaluation or directly obtain a previous stored result of self-assessment evaluation and treatment intensity level applied；

Figure 5B is a third level interface of the application on the mobile computer device after selection of a functional key， Evaluation， which presents a questionnaire for the patient to conduct self-assessment；

Figure 5C is a fourth level interface on the mobile computer device in the application showing results of the evaluation， after completing the self-assessment in Figure 5B；

Figure 5D is a third level interface on the mobile computer device in the application showing a report after selection of a functional key， Result.

Figure 6A is an interface on the mobile computer device in the application showing a diary system including a reminder system；

Figure 6B is an interface on the mobile computer device in the application that permits setting of the reminder system；

Figure 7A is an interface on the mobile computer device in the application that shows a list of doctors accessible from the application；

Figure 7B is an interface on the mobile computer device in the application showing details of a selected doctor provided in the list of doctors in Figure 7A；

Figure 8A to 8C are interfaces of pre-stored game programs in the application；

Figure 9 is a schematic illustration of a waveform of electrical stimulation generated by the device in Figure 1A； and

Figure 10 is a table showing respective treatment sessions and cycles once STIM key in Figure 4A is actuated.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENT

Referring to Figures 1A and 1B there is shown a urinary incontinence treatment device 100 of a urinary incontinence management system in accordance with the invention， in particular， the device is a pelvic floor muscle strengthening device 100， by way of electrical and mechanical stimulation. The mechanical stimulation comprises vibration motion generated by the device 100 acting against the pelvic floor muscle of a patient.

The embodiment of the device 100 as shown in Figures 1A and 1B includes a housing 101， a probe 102 at a first end portion of the housing 101 and a control module 103 at a second end portion of the housing 101. Preferably， the first and second end portions are opposite to one another， which permits easy manipulation of the device 100 when in use， with the probe 102 being inserted into the vagina/rectum of a patient. To avoid relying solely on an external source of power where a cable has to be attached when the device 100 is in use， a 3.7V battery is stowed inside the housing 101 for storage of electrical energy to power the device 100. In this specific embodiment， the battery is placed within the first end portion. It is electrically connected to a charging socket provided at a free end 101A of the housing 101 at the second end portion. Preferably， the free end 101A is a rear end of the housing 101. The control module 103 includes a user interface platform 103A which has an LED indicator 103B that shows the charging state of the device 100 and an on-off switch 103C for actuating the device 100.

The probe 102 is generally oblong in shape with a cross-sectional area that changes from one end to another across length of the device 100. Head of the probe 102 is bulb like with a smooth external surface， followed by a conical periphery tapering away from the head with two

electrode pads

102A and 102B arranged opposite one another. Behind the head of the probe 102， there are two oblong apertures provided opposite one another for accommodating the

electrode pads

102A and 102B. These electrode pads are +ve and -ve electrodes electrically connected to each other inside a hollow interior of the of the housing 101.

Within the hollow interior there is provided a PCB which includes a vibration module/circuit with circuit 301 and an electric stimulation module with circuit 302 connected to a motor 300 and the

electrode pads

102A and 102B respectively. The PCB further includes the switch 103C， the LED indicator 103A and a Bluetooth MCU 303.

Referring to Figure 2， the device 100 is controllable by the control module 103 and/or a mobile controller in the form of a mobile computer device 400 through a pre-installed application. The Bluetooth MCU 303 permits wireless communication between the device 100 and the mobile computer device 400 and has direct control over both the vibration module/circuit and circuit 301 and the electrical stimulation module/circuit and circuit 302. The vibration module/circuit and circuit 301 controls the motor 300 to bring about a desired vibration pattern and/or intensity， whereas the electrical stimulation module/circuit and circuit 302 controls the +ve and -ve

electrodes

102A and 102B to bring about a desired pattern and/or intensity of electrical stimulation.

The exact mechanism involved in improvement of urinary symptoms through electrical stimulation is not completely understood. Reorganization of spinal reflex and regulation of cortical activity are suggested as important outcomes of electrical stimulation， which would be related to the mechanism of action of this therapy. Some studies showed that transvaginal electrical stimulation causes contractions of the pelvic floor， increasing the number of muscle fibers with rapid contraction， which are responsible for continence in situations of stress. There is therefore a proposal of using vibration in addition or supplementary to electrical stimulation for enhancing effectiveness.

The device 100 can be switched on and off by activating the on-off switch 103C. Command from the mobile computer device 400 is received through wireless channel， preferably Bluetooth by the Bluetooth MCU 303. Based on the command， the MCU 303 instructs the electrical stimulation module/circuit and circuit 302 and/or the vibration module/circuit and circuit 301 to bring about the desired stimulation.

The device 100 may be stored in a storage box 200 as shown in Figure 1B. The storage box 200 defines a shaped interior for close-fit accommodation of the device 100 and securely fixing the position of the device 100 within the storage box 200. In a preferred embodiment of the storage box 200， an aperture 201 is provided to permit for passage of a cable for electrically connecting the device 100 to an external power source. Alternatively， a rechargeable battery or power bank is provided in the storage box 200 which includes a power inlet 201 for electrical connection with an external power source by a cable. The battery of the storage box 200 may perform as a power bank including power outlet for establishing electric contact with the device 100 such that power stored in the battery of the storage box 200 may be used to charge the battery in the device 100.

In a preferred embodiment， the power bank in the storage box 200 is useful in electrically charging the battery in the device 100 by way of induction charging. In such embodiment， the storage box 200 may not include any power outlet for establishing physical connection with the device 100.

The Bluetooth MCU is in direct control of the vibration module/circuit and circuit 301 and the electrical stimulation module/circuit and circuit 302 respectively. The electrical connection with these modules and

circuits

301 and 302 are in parallel such that when any one of them becomes faulty， the function of the remaining other is unaffected. A Bluetooth module may be integrated with the modules and

circuits

301 and 302 to form the Bluetooth MCU 303. It is low power and highly integrated such that the space required for the overall electric connection is minimal yet offering wireless connectivity without compromising on costs and power consumption. The motor 300 is only connected to the vibration module/circuit and circuit 301 whereas the

electrodes

102A and 102B are connected to the electrical stimulation module/circuit and circuit 302 such that the motor 300 and the

electrodes

102A and 102B are completely independent from one another.

Referring to figures 3A to 8C， there is shown a control system of the device 100. The control system includes a mobile computer device 400 which acts as a user interface for initiating controls of the device 100 remotely. The mobile computer device 400 is modified to become a mobile controller of the device 100. Preferably， the mobile computer device 400 is installed with an application designed to communication with the device 100.

The mobile computer device 400， when modified， includes a specific operating system with specific sets of order or instructions for controlling the device 100. The specific operating system comprises a control system for controlling the device 100.

A zero level interfaces 900， 901， 902 is generated and presented when the operating system is activated for permitting a user to access the control system. The zero level interfaces include a sign-in interface 901 which may lead to a first level interface 500 as shown in Figure 3D when the user entered a pre-set value or may lead to another zero level interface 902 for registration when a Register Here key presented on the sign-in interface 901 is actuated. Once the control system is initiated， the mobile computer device 400 generates the first level interface 500. The device 400 also initiates and establishes pairing and connection with the device 100 by way of wireless connection， preferably Bluetooth connection. Pairing usually occurs in the first encounter of the two

devices

400 and 100 which then remain paired but may connect and disconnect as the user sees fit. More specifically， when the control system is initiated， a key， hereinafter known as the connection key， 501 is made available in the first level interface 500 for the user to actuate. Actuation of the connection key 501 will prompt the device 400 to try establish connection with the device 100. Once the

devices

400 and 100 are connected， re-actuation of the connection key 501 is required to disconnect the two

devices

400 and 100. In an alternative embodiment， connection may be established automatically when the two

devices

400 and 100 are in proximity (e.g. both within a specific range in space) . The two

devices

400 and 100 may disconnect when they are remote from one another (e.g. both outside a specific range in space) . Furthermore， the status of connection 502 between the

devices

400 and 100 is shown in a human readable format in the first level interface 500. A specific device 100， if in connection， is identified in an identification area503 in the first level interface 500. In the zero level interface of Figures 3B and 3C as well as the first level interface 500， four core keys or

icons

504， 505， 506 and 507 are generated and presented in the first level interface 500 for initiating a respective

second level interface

600， 601， 602 and 603. The core keys or

icons

504， 505， 506 and 507 are generated and presented in all different level interfaces to be introduced below. In other words they are common to all level interfaces. A further core key or icon 508 may be included to provide educational information and guidance to a user.

In the preferred embodiment， there are four second level interfaces 600， 601， 602 and 603 which can be generated by actuation of respective core keys or

icons

504， 505， 506 and 507 in the first level interface 500. Each of the second level interfaces 600， 601， 602 and 603 is designed for offering a specific function to the user. Through the second level interfaces 600， 601， 602 and 603， the user will be able to access a plurality of third level interfaces which are generated by and presented on the mobile computer device 400 when a first functional key or icon is initiated 600A， 600B. There are also a plurality of fourth level interfaces which are generated by and presented on the mobile computer device 400 when a second functional key or icon in a third level interface is actuated. The first functional key or icon represents a first level instruction which is then narrowed-down to a more specific second level instruction when one of the second functional key or icon is actuated. The first level instruction prompts the mobile computer device 400 to generate and present a number of specific second functional key or icon for the user to narrow down his instruction that is specific enough for permitting the device 100 or device 400 to perform a specific function.

Treatment

Referring to Figures 4A to 4E， when the key or icon 504 is actuated， the second level interface 600， hereinafter known as the Treatment interface 600， as shown in Figure 4A is generated and presented on the mobile computer device 400. Along with the second level interface 600， two first functional keys or icons， namely the STIM (first option) and Vibration (second option) keys 600A and 600B are generated and made available to the user for selective actuation. These keys 600A and 600B upon actuation provides a first tier treatment instruction. The core keys or

icons

504， 505， 506， 507 and 508 are also generated and presented in the second level interface 600 for establishing interconnection with the other second level interfaces 601， 602 and 603. When the STIM key 600A of the second level interface 600 is actuated， the mobile computer device 400 is prompted to generate and present a third level interface 700， hereinafter known as the STIM interface 700. In the STIM interface 700， five second functional keys or icons 700A to 700E are made available for actuation by the user. These five function keys or icons are known as Stress Incontinence key 700A， Urge Incontinence key 700B， Mixed Incontinence key 700C， Overflow Incontinence key 700D and Pain Relief key 700E. Each of them is related to a specific program of treatment predetermined in the Bluetooth MCU 303 in the device 100. The actuation of any one of them would result in the provision of a second tier treatment instruction to the device 100. The second tier treatment instruction is more specific than the first tier treatment instruction. In each of the second functional keys or icons 700A to 700E there may include a respective further second function keys which upon actuation provide detailed medical information of an incontinence condition represented by each of the second function keys or icons 700A to 700E.

The actuation of any one of the second functional keys or icons 700A to 700E prompts the system to generate and present a fourth level interface 800 which is a Mode Specific fourth level interface 800 e.g. a Stress Incontinence interface 800. A countdown clock 800A and a number of control keys are provided， namely a Play key 800B， Stop key 800C and an Again key 800D. The selected mode of treatment 800E is presented in the Mode Specific fourth level interface 800 for the user’s information. In the preferred embodiment， the previous level of intensity for electrical stimulation 800F may be presented in the fourth level interface. By actuating the Play key 800B， the user initiates the treatment. By actuating the Stop key 800C， the user temporarily stop the treatment and by actuating the Again key 800D， the user restarts the treatment. The countdown clock calculate and record the time for as long as the treatment is commenced. It stops counting when the treatment is temporarily stopped. In the fourth level interface 800， an entertainment program is generated and presented for manipulation by the user for relaxation. For example， there is a song playing program 800G that allows the user to listen to music during the treatment. A list of songs may be provided with the application for relaxation and enjoyment. Alternatively， the application may have access to the user’s song list stored in the mobile computer device 400 for selection and enjoyment. A number of games may also be provided with the application for selection and enjoyment as shown in Figures 8A to 8C.

For example， actuation of the Stress Incontinence key 700A constitutes an instruction to the device 100 prompting the system to generate the fourth level interface 800 showing the specific mode of treatment “Stress Incontinence” . By actuating the Play key 800B， the system prompts the Bluetooth MCU 303 to instruct the

electrodes

102A and 102B to bring about a specific pattern and duration of electrical stimulation. Referring to Figures 9 and 10， there is shown examples of electrical stimulation treatment offered in different programs pre-set for different incontinence condition. Taking stress incontinence as an example， the frequency of electrical stimulation is about 50Hz with a pulse width of 300 us. An up ramp time is about 1 second and the down ramp time is also about 1 second. The actual work time is around 5 seconds and the rest time between each stimulation is about 10 seconds. Such stimulation is repeated until a whole treatment time of 30 minutes is achieved. This forms one session of treatment. Depending on the specific condition of each user， a cycle of treatment involves three to five sessions of treatment per week. The whole course of treatment would involve four to eight cycles of treatment.

For urge inconsistency， the frequency of electrical stimulation is around 10Hz with a pulse width of 200us， An up ramp time is about 1 second and the down ramp time is also about 1 second. The actual work time is around 5 seconds and the rest time between each stimulation is about 10 seconds. The same applies to mixed incontinence except that the frequency of electrical stimulation is about 20Hz with a pulse width of 250us. Such stimulation is repeated until a whole treatment time of 30 minutes is achieved. This forms one session of treatment. Depending on the specific condition of each user， a cycle of treatment involves three to five sessions of treatment per week. The whole course of treatment would involve four to eight cycles of treatment.

As to overflow inconsistency， the frequency of electrical stimulation is around 35Hz with a pulse width of 250us， An up ramp time is about 1 second and the down ramp time is also about 1 second. The actual work time is around 3 seconds and the rest time between each stimulation is about 6 seconds. Such stimulation is repeated until a whole treatment time of 30 minutes is achieved. This forms one session of treatment. Depending on the specific condition of each user， a cycle of treatment involves three to five sessions of treatment per week. The whole course of treatment would involve four to eight cycles of treatment.

Concerning Pelvic Floor Pain treatment， the frequency of electrical stimulation is around 3Hz with a pulse width of 200us， The stimulation is continuous without ramp time or rest time until a whole treatment time of 20 minutes is achieved. This forms one session of treatment. Depending on the specific condition of each user， a cycle of treatment involves three to five sessions of treatment per week. The whole course of treatment would involve four to eight cycles of treatment.

By pressing the core key or icon 504， the mobile computer device 400 generates and presents the Treatment interface 600 to the user. By actuating the Vibration key 600B， it prompts the mobile computer device 400 to generate a third level interface 701 which are hereinafter known as the Vibration interface 701. In the vibration treatment， two different modes are available namely the continuous mode and pulse mode. In continuous mode， vibration is continuous while in the pulse mode， vibration is intermittent at regular intervals. The pulse mode is further subdivided into pulse mode-treatment and pulse mode-training. For the pulse mode-treatment， the vibration generated by the device 100 causes contraction of the pelvic floor muscle whereas in the pulse mode-training， the vibration generated by the device 100 is only a signal or indicator prompting the user to voluntarily contract the pelvic floor muscle. To cater for the selection of different modes and their subdivided modes， three first functional keys are available 701A， 701B and 701C. The intensity of vibration may be customized by actuation of three second functional keys 701D to 701F assigned for each of the first functional keys 701A， 701B and 701C. The actuation of the functional keys provides more instructions and the instructions provided by the second functional key 701D to 701F is generally more specific than those provided by the first functional key 701A， 701B and 701C. The actuation of the first and/or second functional keys 701A to 701F prompts the mobile computer device 400 to send instructions to the device 100 by way of Bluetooth communication which is received by the Bluetooth MCU 303 in the device 100 which interprets the instructions and translate into a predetermined pattern and duration of vibration. As mentioned above， the user may identify a preferred intensity of vibration by actuating one of the Intensity 1 key 701D， Intensity 2 key 701E or Intensity 3 key 701F. Each of these keys 701D to 701F represent a specific intensity of vibration. When any one of these key is actuated， instructions are sent to the device 100 which is received by the Bluetooth MCU 303 for interpretation. Specific instructions are then provided by the Bluetooth MCU 303 to the motor 300 to bring about a predetermined pattern， intensity and/or duration of vibration. In an alternative embodiment， the vibration may be of a pre-set intensity when one of the Continuous Mode or Pulse Mode keys 701A or 701C is actuated. The pre-set intensity may be override by the user when the Intensity 1 key 701D， Intensity 2 key 701E or Intensity 3 key 701F is initiated. Once initiated， the mobile computer device 400 provides instructions to the Bluetooth MCU in the device 100 which prompts the motor to alter its output to bring about a desired intensity of vibration. Upon completion of the selection of the mode and intensity，

The actuation of any one of the first and/or second functional keys or icons 7001A to 701F prompts the system to generate and present a fourth level interface 801 which is a Mode Specific fourth level interface 801 e.g. a Continuous Mode interface 801. A countdown clock 801A and a number of control keys are provided， namely a Play key 801B， Stop key 801C and an Again key 801D. The selected mode of treatment 801E is presented in the Mode Specific fourth level interface 801 for the user’s information. By actuating the Play key 801B， the user initiates the treatment. By actuating the Stop key 801C， the user temporarily stop the treatment and by actuating the Again key 801D， the user restarts the treatment. The countdown clock calculate and record the time for as long as the treatment is commenced. It stops counting when the treatment is temporarily stopped. In the fourth level interface 801， an entertainment program is generated and presented for manipulation by the user for relaxation. For example， there is a song playing program 800G that allows the user to listen to music during the treatment. A list of songs may be provided with the application for enjoyment. Alternatively， the application may have access to the user’s song list stored in the mobile computer device 400 for selection and enjoyment. A number of games may also be provided with the application for selection and enjoyment as shown in Figures 8A to 8C.

In each of the second， third and fourth level interfaces 600， 700， 701， 800 and 801， the core icon 504， herein known as the Core Treatment key or icon， permits the user to move up and down one level interface between the Treatment， STIM， Vibration and Mode Specific fourth level interfaces.

By actuating any one of the other

core icons

505， 506， 507 and 508， it prompts the mobile computer device 400 to generate and present the respective functional second level interfaces 601， 602， 603. It may also amount to an overriding stop key putting a previous action to an end.

Evaluation

We now turn to Figures 5A to 5D. If a user actuates the Core key 506 in the first level interface or any of the second， third and fourth level interfaces， the mobile computer device 400 is prompt to generate and present a second level interface known as the Evaluation interface 601. Two functional keys or icons 601A and 601B， known as the Evaluation key 601A and the Result key 601B are generated and presented. By actuating the Evaluation key 601A， it prompts the mobile computer device 400 to generate a pre-stored evaluation questionnaire (e.g. the Revised Urinary Incontinence Scale (RUIS) and/or Incontinence Severity Index (ISI) questionnaires) to be presented in a third level interface， hereinafter known as the Evaluation interface 702， mainly for self-evaluation by the user or a treated person. It can of course be filled in by a third party such as a medical physician on behalf of the user or the treated person.

The completed questionnaire can be saved in a database formed by the mobile computer device 400 specifically for the urinary incontinence management system. Any history of previous treatment conducted is also stored in specific database. The results of the completed questionnaire as well as the previous treatment history can be generated and presented in a third level interface 703 by actuation of the Result key 601B. These include the date of treatment the intensity or level of stimulation as well as the evaluation results recorded if any.

Again， the core keys and icons are available in each of the second and third level interfaces. Their functions are the same as that detailed above.

The Core key 506 is assigned for evaluation function. By actuating Core key 506 at different level interfaces will permit the user to move from one level interface to another within the evaluation function. Actuation of the

other Core keys

504， 505 or 507 will allow the user to access the respective functional second level interfaces 600， 602， 603.

Reminder

Referring to Figures 6A and 6B， there is provided a diary system on a second level interface， hereinafter known as the Diary interface 602. Information of a user such as her period cycle can be entered such that a period of time in the diary is blocked out 602B from treatment as shown in Figure 6A. Information of a previous treatment e.g. start date， mode and status may also be entered voluntarily by the user or by the system itself for calculation of a subsequent treatment sessions， cycles and course. This is shown on a calendar in the Diary interface 602. Indicator 602C is made available to show a completed treatment session which is distinguishable from an indicator 602D showing a partially completed session. Details of previous treatment session 602E are also shown in the Diary interface 602.

One Diary interface 602 is assigned to each type of incontinence a user is suffering from once treatment has been commenced for that specific type of incontinence such that the user is able to retrieve specific history of a specific type of treatment in the Diary interface 602.

Reminder is made available when a Reminder key 602A is switched on which prompts the system to generate a third level interface known as the Reminder interface 704. The reminder interface 704 permit user to customize the reminder to be generated for reminding a user to conduct a treatment session.

Upon completion or pausing of a treatment， the system automatically record such information and present it in the Diary interface 602 as information in relation to the last treatment. In particular， if the previous treatment is incomplete， the duration of performed treatment will be shown to prompt the user to complete the incomplete treatment.

For each type of incontinence， the urinary incontinence management system is pre-set with specific treatment programs which involve consecutive treatment sessions to be performed periodically within a specific time frame. To assist the user in following the treatment program thoroughly， the Diary interface 602 also contains the Reminder key 602B which if turned on prompts the diary and reminder system to generate a reminder in human perceivable form urging the user to perform a next treatment. During the block out period， the generation of reminder as well as the treatment sessions are temporarily suspended. The suspension of the reminder and treatment session is due to the generation of an overriding instructions by the mobile computer device 400 based on a calculation making use of the information entered by the user. Outside the block out period， the urinary incontinence management system will remind the user of an upcoming treatment session.

All pre-set treatment parameters may be altered by way of provision of new set of instructions or rules downloadable from internet in the form of a version update.

Consultation

The Core key 507 if actuated prompts the mobile computer device 400 to generate in a second user interface 603 (hereinafter known as e-Health interface) a list of medical physicians. Each medical physician occupies a key 603A to 603F which if actuate prompts the mobile computer device 400 to generate and presents a third level interface hereinafter known as Doctor interface 705 which provides detailed information of the selected medical physician. Functional keys such as a Full Report key 705A and a Summary Report key 705B are made available for selective actuation by a user to produce and send through internet a full medical report or a summary medical report to the selected medical physician.

Communication within the urinary incontinence management system， more specifically between the

devices

100 and 400 may be conducted through wired or wireless communication which is preferably Bluetooth but may well be 2.4GHz， Wireless internet， IR or any type of wireless communication.

In addition to the function as a urinary incontinence management device， the device 100 may be used as a sexual pleasure stimulator.

The invention has been given by way of example only， and various other modifications of and/or alterations to the described embodiment may be made by persons skilled in the art without departing from the scope of the invention as specified in the appended claims.

Claims

A device for treating urinary incontinence comprising：

a housing having a periphery，

a main control unit provided inside the housing，

a motor stowed inside the housing，

a pair of electrodes provided on the periphery of the housing，

wherein the main control unit comprises a wireless communication module， a vibration module/circuit electrically connected to the motor and an electrical stimulation module/circuit electrically connected to the pair of electrodes for generating vibration and electrical stimulation.
The device as claimed in claim 1， wherein the main control unit is an integrated circuit containing the wireless communication module， the vibration module/circuit and the electrical stimulation module/circuit connected in parallel with the wireless communication module in the integrated circuit.
The device as claimed in claim 1 or claim 2， wherein the integrated circuit is adapted to receive instructions through a wireless communication and selectively provide instructions to one of the vibration module/circuit and the electrical stimulation module/circuit.
The device as claimed in any one of claims 1 to 3， wherein the wireless communication module is a Bluetooth module.
The device as claimed in any one of claims 1 to claim 4， wherein the housing includes a rechargeable battery as a power source.
The device as claimed in claim 1， wherein the housing comprises first portion on which the pair of electrodes are provided and a second portion having a control platform.
A urinary incontinence management system comprising the device as claimed in any one of claims 1 to 6 and a storage box which includes a housing defining a space for containing the device， wherein the housing includes a power inlet and a power outlet.
The urinary incontinence management system as claimed in claim 7， wherein the housing includes a power bank in electrical connection with the power inlet.
The urinary incontinence management system as claimed in claim 8， wherein the power bank puts energy into the battery in the device by way of induction.
The urinary incontinence management system as claimed in claim 7 further comprising a mobile controller in wireless communication with the device.
The urinary incontinence management system as claimed in claim 10， wherein the mobile controller comprises a mobile computer device.
A method of managing urinary incontinence comprising the steps of：

providing a device having a main control unit with a wireless communication module， a vibration module/circuit electrically connected to the motor and an electrical stimulation module/circuit electrically connected to the pair of electrodes for generating vibration and electrical stimulation，

providing a mobile controller having a wireless communication module，

permitting pairing of the device and the mobile controller through their respective wireless communication module，

permitting establishment of wireless communication between the device and the mobile controller after the pairing of the device and the mobile controller，

providing first and second options of stimulation on the mobile controller for selective actuation by a user， and

instructing the device， through an established wireless communication， to perform first or second function which corresponding to and based on the first or second option being selectively actuated.
The method as claimed in claim 12 further comprising the step of generating a first level interface on the mobile controller.
The method as claimed in claim 13， wherein the first level interface includes a connection key being generated together with the first level interface.
The method as claimed in claim 14 further comprising the step of establishing wireless communication between the device and the mobile controller by actuating the connection key on the mobile controller.
The method as claimed in claim 13 further comprising the step of providing a core access key on the first level interface.
The method as claimed in claim 16 further comprising the step of generating a second level interface by actuation of the core access key.
The method as claimed in claim 14， wherein the first level interface includes two or more core access keys correspond to two or more respective second level interfaces， actuation of one of the two or more core access key results in generation of a corresponding second level interface for performing a specific function.
The method as claimed in claim 14 further comprising the step of generating a functional access key on the second level interface.
The method as claimed in claim 19 further comprising the step of generating a third level interface by actuation of the functional access key on the second level interface.
The method as claimed in claim 17 further comprising the step of generating two or more core access keys on the second level interface， the two or more core access keys correspond to two or more second level interfaces respectively.
The method as claimed in claim 21 further comprising the step of generating a corresponding second level interface by actuation of one of the two or more core access keys.
The method as claimed in claim 20 further comprising the step of generating a functional access key on the third level interface.
The method as claimed in claim 23 further comprising the step of generating a fourth level interface by actuation of the functional access key on the third level interface.
The method as claimed in claim 20 further comprising the step of generating a core access key on the third level interface， which upon actuation generates a second level interface that replaces the third level interface.
The method as claimed in claim 25 further comprising the step of generating a core access key on the fourth level interface， which upon actuation generates a second level interface that replaces the fourth level interface.
The method as claimed in any one of claims 17 to 26 further comprising the step of providing a reminder interface as a second level interface and generating a reminder in a human perceivable form based on information entered into the mobile controller through the reminder interface.
The method as claimed in claim 27， wherein the reminder includes a series of consecutive reminders generated periodically.
The method as claimed in claim 28 further comprising the step of suspending at least one reminder in the series of consecutive reminders by generating a suspension instruction.
The method as claimed in claim 19， wherein the functional key comprises an evaluation key which upon actuation generates a fillable evaluation questionnaire in a third level interface for self-assessment by a user.
The method as claimed in claim 19， wherein the functional key comprises a report key which upon actuation generates a medical report in a third level interface.
The method as claimed in claim 31， wherein the medical comprises information of a previous treatment and results obtained from completion of the fillable evaluation questionnaire.
The method as claimed in claim 19， wherein the functional key comprises an electrical stimulation key and a vibration stimulation key which upon actuation provides a first tier treatment instructions and prompts the mobile controller to generate a third level interface.
The method as claimed in claim 33 further comprising the step of generating two or more functional keys in the third level interface which upon actuation provides a second tier treatment instructions and prompts the mobile controller to generate a fourth level interface.
The method as claimed in claim 34， wherein the second tier treatment instructions is more specific than the first tier treatment instructions.
The method as claimed in claim 34， wherein each of the two or more functional keys correspond to a specific and different mode of electrical stimulation for treating a specific type of urinary incontinence.
The method as claimed in claim 34， wherein each of the two or more functional keys correspond to a specific and different mode of vibration stimulation.
The method as claimed in claim 37， wherein the functional keys are subdivided into first and second functional keys， instructions provided by actuation of a second functional key is more specific than instructions provided by actuation of a first functional key.
The method as claimed in claim 38， wherein the second functional key is assigned for adjustment of vibration intensity.
The method as claimed in claim 38 further comprising the step of actuating the first functional key to prompt the device in generating vibration stimulation which functions as an indicator to the user for taking a specific action.
The method as claimed in claim 17， further comprising the step of generating and presenting a list of medical physician information in a second level interface， wherein each medical physician information constitute a key actuable by a user for establishing contact with the medical physician.
The method as claim in claim 41 further comprising the step of generating and presenting a third level interface which contain specific information of one medical physician and includes functional key for establishing contact with said one medical physician.
The method as claimed in claim 17， wherein the second level interface comprises a diary interface which contains historical information of a conducted treatment.
The method as claimed in claim 43， wherein the diary interface comprises indicator distinguishing a fully completed treatment from a partially completed treatment.
The method as claimed in claim 24， wherein the fourth level interface comprises any one of a group containing a game interface for entertaining a user， a， audio playing interface for music enjoyment， a countdown interface showing specific treatment mode and status and a self-evaluation result interface.