Transcutaneous Tibial Nerve Stimulation for Urgency Urinary Incontinence (TTeNS)

Transcutaneous Tibial Nerve Stimulation for Urgency Urinary Incontinence: A Sham-Controlled Trial

This is a single-center, double-blinded, randomized controlled trial evaluating the efficacy of TTNS versus a sham intervention. Both interventions will be performed by participants in their homes after standardized instruction. The primary outcome is a comparison of the mean change in OAB-q scores before and after treatment between the intervention and control groups. Changes in the number of urgency incontinence episodes and an estimation of cost effectiveness will additionally be measured. Intention to treat analysis will be performed.

Study Overview

• Status: Active, not recruiting
• Conditions: Overactive Bladder; Urge Incontinence
• Intervention / Treatment: Device: transcutaneous tibial nerve stimulation (TTNS); Device: transcutaneous electrical stimulation (TENS)

• Study Type: Interventional
• Enrollment (Estimated): 99
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92110
      • Kaiser Permanente San Diego

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• ≥ 6 episodes urgency incontinence on 3-day voiding diary
• Duration of symptoms ≥ 3 months
• Off antimuscarinic or 3-adrenoreceptor agonist therapy for 2 weeks
• No known neurologic disease
• Ability to complete home sessions and clinic follow up
• Ability to complete voiding diaries
• Internet access and proficiency
• English or Spanish-speaking

Exclusion Criteria:

• Pregnant
• Known or suspected urinary retention
• Symptomatic urinary tract infection unresolved at the time of randomization
• Recurrent urinary tract infection (≥ 3/12 months)
• Bladder pain syndrome
• Known or suspected advanced (stage III or IV) pelvic organ prolapse
• Neurogenic bladder
• Current or prior bladder malignancy
• Current or previous use of bladder Botox injections, percutaneous tibial nerve stimulation, or sacral neuromodulation
• Pacemaker or other implantable device
• Disease affecting lower extremities
• Bilateral metallic lower limb implant
• Incarceration

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; 30-minute treatments, twice weekly x12 weeks	Device: transcutaneous tibial nerve stimulation (TTNS); TTNS is a non-invasive, surface electrode therapeutic stimulation technique available for home administration that has been proposed as a treatment for overactive bladder.
Sham Comparator: Sham Group; 30-minute treatments, twice weekly x12 weeks	Device: transcutaneous electrical stimulation (TENS); The sham intervention is designed to appear almost identical to the TTNS intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overactive Bladder Questionnaire (OAB-q)	To evaluate the efficacy of a 12-week course of TTNS in reducing urgency urinary incontinence (UUI) symptom bother in the intervention versus sham group.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Voiding diary	To evaluate the efficacy of a 12-week course of TTNS in reducing the frequency of UUI episodes in the intervention versus sham group.	12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incremental cost-effectiveness ratio (ICER)	To describe the cost effectiveness of a 12-week course of home-based TTNS therapy using an ICER calculated from the sum of direct medical and indirect non-medical costs relative to health-related quality of life, as measured by the European Quality of Life-5 Dimensions index.	12 weeks

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Collaborators: American Urogynecologic Society
• Investigators: Principal Investigator: Nemi M Shah, MD, University of California San Diego/Kaiser Permanente San Diego

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2021
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: June 15, 2021
• First Submitted That Met QC Criteria: June 15, 2021
• First Posted (Actual): June 23, 2021

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 20, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: overactive bladder; transcutaneous electrical nerve stimulation; urgency urinary incontinence; tibial nerve stimulation
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder, Overactive; Urinary Incontinence; Enuresis; Urinary Incontinence, Urge
• Other Study ID Numbers: 12791

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No