Transcutaneous Tibial Nerve Stimulation for Urgency Urinary Incontinence

Not Applicable

Active, not recruiting

• Conditions: Urge Incontinence; Overactive Bladder
• Interventions: Device: transcutaneous tibial nerve stimulation (TTNS); Device: transcutaneous electrical stimulation (TENS)

• Registration Number: NCT04936464
• Lead Sponsor: Kaiser Permanente

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-15
• Study First Submitted QC: 2021-06-15
• Study First Posted: 2021-06-23
• Study Start: 2021-09-20
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-20
• Last Update Posted: 2023-10-23
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 99

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	transcutaneous tibial nerve stimulation (TTNS)	30-minute treatments, twice weekly x12 weeks
Sham Group	transcutaneous electrical stimulation (TENS)	30-minute treatments, twice weekly x12 weeks

Primary Outcome Measures

Name	Time	Method
Overactive Bladder Questionnaire (OAB-q)	12 weeks	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Kaiser Permanente San Diego; 🇺🇸 San Diego, California, United States