TEST-ON - Does iStim Reduce Urinary Urgency?

NCT04957524 | Completed DMC

• 1 other identifier: 21-005834
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Percentage of assigned treatment sessions that were successfully completed

  4 weeks

• Change in Urinary 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

  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.

Study Arms (2)

Set Amplitude

ACTIVE COMPARATOR

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

Customizable Amplitude

EXPERIMENTAL

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

Interventions

iStim TENS unit and Transvaginal Probe 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; Set Amplitude

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA Center for Women's Pelvic Health

Los Angeles, California, 90095, United States

Location

Related Publications (9)

• Yamanishi T, Yasuda K, Sakakibara R, Hattori T, Suda S. Randomized, double-blind study of electrical stimulation for urinary incontinence due to detrusor overactivity. Urology. 2000 Mar;55(3):353-7. doi: 10.1016/s0090-4295(99)00476-8.

  PMID: 10699609 BACKGROUND

• 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.

  PMID: 11435843 BACKGROUND

• 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.

  PMID: 8732985 BACKGROUND

• Messelink EJ. The overactive bladder and the role of the pelvic floor muscles. BJU Int. 1999 Mar;83 Suppl 2:31-5. doi: 10.1046/j.1464-410x.83.s2.7.x. No abstract available.

  PMID: 10210602 BACKGROUND

• Hoffman D. Understanding multisymptom presentations in chronic pelvic pain: the inter-relationships between the viscera and myofascial pelvic floor dysfunction. Curr Pain Headache Rep. 2011 Oct;15(5):343-6. doi: 10.1007/s11916-011-0215-1.

  PMID: 21739128 BACKGROUND

• Guralnick ML, Kelly H, Engelke H, Koduri S, O'Connor RC. InTone: a novel pelvic floor rehabilitation device for urinary incontinence. Int Urogynecol J. 2015 Jan;26(1):99-106. doi: 10.1007/s00192-014-2476-9. Epub 2014 Jul 30.

  PMID: 25074260 BACKGROUND

• 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.

  PMID: 9322620 BACKGROUND

• 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.

  PMID: 16752244 BACKGROUND

• 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.

  PMID: 40135809 DERIVED

MeSH Terms

Conditions

Urinary Bladder, Overactive; Nocturia

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Anne L Ackerman, MD, PhD

  UCLA, Department of Urology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants will be masked to which treatment they are receiving in which order. They will be randomly assigned to one of two groups. The randomization assignments will be generated by the principal statistician in the UCLA Department of Urology with a random number generator algorithm in Microsoft Excel so that the proposed recruited patients will be randomly assigned to control or intervention group in an equal amount per group. This will be stored in a central location on a password protected system on the UCLA Health Box for the research staff to access and as each patient is randomized they will use the next available group assignment on the sheet and cross them off. This will be closely monitored to maintain appropriate use. The randomization will occur at the time of enrollment.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Urology and Director of Research

Model Details: Patient will then be randomized to treatment A followed by treamtent B (Group 1) or treatment B followed by treatment A (Group 2).

Study Record Dates

• First Submitted: June 23, 2021
• First Posted: July 12, 2021
• Study Start: December 20, 2021
• Primary Completion: May 15, 2023
• Study Completion: February 11, 2025
• Last Updated: May 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)