NCT04936464

Transcutaneous Tibial Nerve Stimulation for Urgency Urinary Incontinence

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 99 (estimated)
• Sponsor: Kaiser Permanente · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Urge Incontinence
• Overactive Bladder

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-09-20
• Primary completion: 2024-06-30
• Completion: 2024-06-30
• First posted: 2021-06-23
• Last updated: 2023-10-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study