TEST-ON - Does iStim Reduce Urinary Urgency?

Study Overview
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Brief Summary
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Overactive bladder (OAB) is a chronic disorder with an overall prevalence in the adult population of over 10%, but that may exceed 40% in elderly groups. Most overactive bladder treatments are aimed at decreasing urgency incontinence episodes. The purpose of this study is to determine whether an at-home transvaginal electrical stimulation (TES) program works to alleviate symptoms of urgency in patients with urinary urgency and frequency without incontinence. This is a cross-over trial. Women >18 yo presenting with OAB-dry will be randomized to receive one of two TES at home programs for 4 weeks. After completion of the program, the participant's symptoms will be assessed with standardized patient questionnaires. There will then be a 3 week washout period followed by the second at-home TES program. At the completion of the second program, the participant's symptoms will be assessed with the same standardized questionnaires. The participants will be followed for 6 months following the completion of the TES program.

Detailed Description
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This will be a prospective randomized cross over trial. We will recruit women who present to clinic to see a Female Pelvic Medicine and Reconstructive Surgery, fellowship-trained provider within the UCLA Health System with the symptoms of OAB-dry and have failed or decline anti-cholinergic therapy. Screening: Patients will be made aware of the study by their physician. Interested subjects will interact with study staff in person or by telephone for a complete description of the study. If they wish to continue, they will be screened for eligibility by study staff. If eligible, they will be given as much time as they wish to complete the process of informed consent and have their questions answered. Consent will be obtained electronically using the RedCap system. After informed consent, subjects will be asked to complete intake questionnaires, sent through the RedCap site. These questionnaires include the International Consultation on Incontinence Questionnaire-Female Lower Urinary Tract Symptoms (ICIQ-FLUTS), female GenitoUrinary Pain Index (fGUPI), Pelvic Organ Prolapse Distress Inventory (POPDI-6) portion of the Pelvic Floor Disability Index (PFDI), the first 8 questions of the OverActive Bladder questionnaire (OAB-q), the last question of the AUA symptom score, and the Urgency Perception Scale: UPC. After informed consent, study staff will access subjects' medical records to obtain the results of standard care procedures that are regularly performed for patients with this symptomatology, specifically, pelvic exam and urodynamics. Participants will be asked to make a research visit for training and to obtain materials. They will be issued the iStim device. Both groups will be oriented to the vaginal stimulation device which includes the iStim TENS unit and Transvaginal Probe. The iStim TENS unit delivers a bipolar square wave that can be delivered over a range of 0 to 100 mA. On the TENS unit the patient can set frequency, duration of stimulation, pulse duration, and amplitude. During each participant's in-person visit they will be instructed by trained study staff on how to use the electrical stimulation. Patients will be randomized to treatment A followed by treatment B (Group 1) or treatment B followed by treatment A (Group 2). The patients will be blinded to which treatment they are receiving first. Each treatment phase will be 4 weeks in duration. The washout period between phases will be three weeks. Patients will be given a log to record each session completed at home in order to determine compliance. They will also be asked to record the amplitude achieved for each session in the treatment phase. Patients will be able to report adverse events electronically through RedCap or by contacting study staff directly. At the end of each 4-week treatment patients will be asked to complete the same intake questionnaires again with the addition of the select questions from the modified version of the Overactive Bladder Patient Satisfaction with Treatment Questionnaire (OAB-PSTQ) and Patient Global Assessment (PGA) which assesses their perception of the intervention. At the end of the intervention, participants will be asked to complete a bladder diary again using the same IUGA bladder diary. Participants will be followed through their medical record for 6 months after completion of study activities. Further OAB therapies tried will be recorded as well as pelvic exams and/or urodynamics done as part of their standard care. They will be asked to complete the set of intake questionnaires once more at the end of 6 months.

Official Title
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Transvaginal Electrical Stimulation for the Treatment of OAB-dry

Conditions
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Overactive Bladder, Urgency-frequency Syndrome, Urinary Frequency More Than Once at Night

Intervention / Treatment
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* Device: iStim TENS unit and Transvaginal Probe


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female Age > 18 years old English speaking OAB symptoms for greater than 3 months duration defined as: Urgency: Answer to OAB-q3 > 4] Frequency: greater than 8 voids on bladder diary during waking hours and OAB-q1 > 3 No urinary urge incontinence: OAB-q8 < 2 and OAB-q4 < 2 No significant pelvic pain: fGUPI4 < 4 Exclusion Criteria: Age less than 18 Pregnancy Vaginal infection or lesion Neurogenic bladder Immunocompromised state (hx of transplant, on immunosuppressing drugs) PVR >150cc Urinary tract infections Neurogenic bladder Reduced perception of vaginal sensation Metallic implants Implanted electrical devices (i.e. pace maker)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Patient will then be randomized to treatment A followed by treamtent B (Group 1) or treatment B followed by treatment A (Group 2).
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Set Amplitude<br>This arm is to test a specific amplitude. Participants will be instructed to set the amplitude to 20 mA, frequency to 20 Hz, and pulse duration to 5 mS. The parameters will stay the same for the entire session. This stimulation will last 15 minutes and patients will be instructed to perform the at-home therapy once per day. | Device: iStim TENS unit and Transvaginal Probe<br>* iStim TENS unit and Transvaginal Probe are both commercially available products. TENS units work by delivering small electrical impulses through electrodes either attached to the skin or through a transvaginal probe. iStim transvaginal probe will be inserted vaginally to provide transvaginal electrical stimulation.<br>|
| Experimental: Customizable Amplitude<br>In this arm, the participant will set the frequency to 12 Hz and pulse duration to 1 millisecond. The participant will be instructed to increase the amplitude gradually and set it at the maximal tolerable amplitude. This stimulation will last 15 minutes and patients will be instructed to perform the at-home therapy once per day. | Device: iStim TENS unit and Transvaginal Probe<br>* iStim TENS unit and Transvaginal Probe are both commercially available products. TENS units work by delivering small electrical impulses through electrodes either attached to the skin or through a transvaginal probe. iStim transvaginal probe will be inserted vaginally to provide transvaginal electrical stimulation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary urgency | The primary outcome is the change in participant's reported urgency as measured by the composite score of the first 8 questions of the OAB-q questionnaire. The questionnaire is out of 8 with higher scores corresponding with more bother from urinary urgency. The primary outcome is the difference between the pre-treament and post-treatment scores. The range is 0 to 48 with a larger difference corresponding to more improvement in patient's urgency over the study period. | This will be the difference in score from the date of enrollment to the end of both treatment arms. This will range from 11 weeks to 20 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of assigned treatment sessions that were successfully completed | Number of home programs completed compared to planned treatments based on paper treatment log completed by patient. Range is 0 to 100% completion. | 4 weeks | 
| Change in Urinary Urgency Episodes | Change in number of urgency episodes (per 24 hours) as measured on the voiding diaries. This will be the difference in number of urgency episodes pretreatment compared to posttreatment. The range is 0 to 10 urgency episodes. | This will be the difference in score from the date of enrollment to the end of both treatment arms. This will range from 11 weeks to 20 weeks. | 
| Change in number of micturitions per 24 hours | Change in number of micturition episodes (per 24 hours) as measured on the voiding diaries. This will be the difference in number of micturition episodes pretreatment compared to post-treatment. The range is 0 to 20 micturition episodes. | This will be the difference in score from the date of enrollment to the end of both treatment arms. This will range from 11 weeks to 20 weeks. |