Transcutaneous Tibial Nerve Stimulation for Urgency Urinary Incontinence

NCT04936464 | Unknown DMC FDA Device

• 1 other identifier: 12791
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Urge Incontinence; Overactive Bladder

Keywords

tibial nerve stimulation; transcutaneous electrical nerve stimulation; overactive bladder; urgency urinary incontinence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Voiding diary

  12 weeks

Other Outcomes (1)

• Incremental cost-effectiveness ratio (ICER)

  12 weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

30-minute treatments, twice weekly x12 weeks

Device: transcutaneous tibial nerve stimulation (TTNS)

Sham Group

SHAM COMPARATOR

30-minute treatments, twice weekly x12 weeks

Device: transcutaneous electrical stimulation (TENS)

Interventions

transcutaneous tibial nerve stimulation (TTNS) DEVICE

TTNS is a non-invasive, surface electrode therapeutic stimulation technique available for home administration that has been proposed as a treatment for overactive bladder.

Intervention Group

transcutaneous electrical stimulation (TENS) DEVICE

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

Sham Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Trial is open to biologically female participants only as this is the target population of interest.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaiser Permanente: lead
• American Urogynecologic Society: collaborator

Study Sites (1)

Kaiser Permanente San Diego

San Diego, California, 92110, United States

Location

Related Publications (1)

• Shah NM, Lukacz ES, Ferrante KL, Menefee SA. Transcutaneous Tibial Nerve Stimulation for Urge Incontinence: A Randomized Clinical Trial. Urogynecology (Phila). 2025 Mar 1;31(3):225-233. doi: 10.1097/SPV.0000000000001616. Epub 2024 Dec 13.

  PMID: 39621424 DERIVED

MeSH Terms

Conditions

Urinary Incontinence, Urge; Urinary Bladder, Overactive

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; 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; Urinary Bladder Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Nemi M Shah, MD

  University of California San Diego/Kaiser Permanente San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2021
• First Posted: June 23, 2021
• Study Start: September 20, 2021
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)