Clinical trial NCT04957524: TEST-ON - Does iStim Reduce Urinary Urgency?
Official title: Transvaginal Electrical Stimulation for the Treatment of OAB-dry
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overactive Bladder
Urgency-frequency Syndrome
Urinary Frequency More Than Once at Night
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2021-07-12
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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).
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: 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.
Secondary outcomes:
measure: Percentage of assigned treatment sessions that were successfully completed
timeFrame: 4 weeks
measure: Change in Urinary Urgency Episodes
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.
measure: Change in number of micturitions per 24 hours
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.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Center for Women's Pelvic Health
state: California
Study officials:
affiliation: UCLA, Department of Urology
name: Anne L Ackerman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Brubaker L, Benson JT, Bent A, Clark A, Shott S. Transvaginal electrical stimulation for female urinary incontinence. Am J Obstet Gynecol. 1997 Sep;177(3):536-40. doi: 10.1016/s0002-9378(97)70142-x.
citation: Amaro JL, Gameiro MO, Kawano PR, Padovani CR. Intravaginal electrical stimulation: a randomized, double-blind study on the treatment of mixed urinary incontinence. Acta Obstet Gynecol Scand. 2006;85(5):619-22. doi: 10.1080/00016340500495058.