TEST-ON - Does iStim Reduce Urinary Urgency? (NCT04957524) | Clinical Trial Compass
CompletedNot Applicable
TEST-ON - Does iStim Reduce Urinary Urgency?
United States24 participantsStarted 2021-12-20
Plain-language summary
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.
Who can participate
Age range
18 Years – 120 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Urinary urgency
Timeframe: 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.