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Transcutaneous Tibial Nerve Stimulation for Urgency Urinary Incontinence

NCT04936464 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2023-10-23

No results posted yet for this study

Summary

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.

Conditions

Interventions

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.

DEVICE

transcutaneous electrical stimulation (TENS)

The sham intervention is designed to appear almost identical to the TTNS intervention.

Sponsors & Collaborators

  • American Urogynecologic Society

    collaborator OTHER

  • Kaiser Permanente

    lead OTHER

Principal Investigators

  • Nemi M Shah, MD · University of California San Diego/Kaiser Permanente San Diego

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-20
Primary Completion
2024-06-30
Completion
2024-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04936464 on ClinicalTrials.gov