TTeNS: Transcutaneous Tibial Nerve Stimulation for Urgency Urinary Incontinence

• Sponsor: Kaiser Permanente (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT04936464
• Collaborator: American Urogynecologic Society (Other)
• Enrollment: 99
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 18.3
• Patients Per Site Per Month: 5.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Urge Incontinence; Overactive Bladder	Device: transcutaneous tibial nerve stimulation (TTNS); Device: transcutaneous electrical stimulation (TENS)	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 99 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Transcutaneous Tibial Nerve Stimulation for Urgency Urinary Incontinence: A Sham-Controlled Trial
• Actual Study Start Date: Sep 20, 2021
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Mar 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Group	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	Device: transcutaneous electrical stimulation (TENS); The sham intervention is designed to appear almost identical to the TTNS intervention.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

Other Outcome Measures

1. Incremental cost-effectiveness ratio (ICER) [12 weeks]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kaiser Permanente San Diego	San Diego	California	United States	92110

Sponsors and Collaborators

• Kaiser Permanente
• American Urogynecologic Society

Investigators

• Principal Investigator: Nemi M Shah, MD, University of California San Diego/Kaiser Permanente San Diego

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kaiser Permanente
• ClinicalTrials.gov Identifier: NCT04936464
• Other Study ID Numbers: 12791
• First Posted: Jun 23, 2021
• Last Update Posted: Dec 16, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Kaiser Permanente: tibial nerve stimulation; transcutaneous electrical nerve stimulation; overactive bladder; urgency urinary incontinence
• Additional relevant MeSH terms: Urinary Incontinence; Enuresis; Urinary Bladder, Overactive; Urinary Incontinence, Urge

Study Results

No Results Posted as of Dec 16, 2021