TEST-ON - Does iStim Reduce Urinary Urgency?

NCT ID: NCT04957524

Last Updated: 2025-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-20
• Study Completion Date: 2025-02-11

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Set Amplitude

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.

Group Type: ACTIVE_COMPARATOR

iStim TENS unit and Transvaginal Probe

Intervention Type: DEVICE

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.

Customizable Amplitude

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.

Group Type: EXPERIMENTAL

iStim TENS unit and Transvaginal Probe

Intervention Type: DEVICE

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.

Interventions

iStim TENS unit and Transvaginal Probe

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.

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Anne Lenore Ackerman

Assistant Professor of Urology and Director of Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anne L Ackerman, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UCLA, Department of Urology

Locations

UCLA Center for Women's Pelvic Health

Los Angeles, California, United States

Countries

United States

References

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Reference Type: BACKGROUND

PMID: 10699609 (View on PubMed)

Soomro NA, Khadra MH, Robson W, Neal DE. A crossover randomized trial of transcutaneous electrical nerve stimulation and oxybutynin in patients with detrusor instability. J Urol. 2001 Jul;166(1):146-9.

Reference Type: BACKGROUND

PMID: 11435843 (View on PubMed)

Primus G, Kramer G. Maximal external electrical stimulation for treatment of neurogenic or non-neurogenic urgency and/or urge incontinence. Neurourol Urodyn. 1996;15(3):187-94. doi: 10.1002/(SICI)1520-6777(1996)15:33.0.CO;2-B.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 10210602 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 25074260 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9322620 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 16752244 (View on PubMed)

Torosis M, Stothers L, Cisneros C, Dominique G, Lenore Ackerman A. Transvaginal Electrical Stimulation for Treatment of Overactive Bladder Without Incontinence: A Pilot Cross-Over Clinical Trial. Neurourol Urodyn. 2025 Jun;44(5):977-986. doi: 10.1002/nau.70034. Epub 2025 Mar 26.

Reference Type: DERIVED

PMID: 40135809 (View on PubMed)

Other Identifiers

21-005834

Identifier Type: -

Identifier Source: org_study_id