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Transcutaneous Tibial Nerve Stimulation for Urgency Urinary Incontinence (TTeNS)

Primary Purpose

Urge Incontinence, Overactive Bladder

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
transcutaneous tibial nerve stimulation (TTNS)
transcutaneous electrical stimulation (TENS)
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urge Incontinence focused on measuring tibial nerve stimulation, transcutaneous electrical nerve stimulation, overactive bladder, urgency urinary incontinence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Kaiser Permanente San Diego

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Intervention Group

Sham Group

Arm Description

30-minute treatments, twice weekly x12 weeks

30-minute treatments, twice weekly x12 weeks

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
June 15, 2021
Last Updated
October 20, 2023
Sponsor
Kaiser Permanente
Collaborators
American Urogynecologic Society
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1. Study Identification

Unique Protocol Identification Number
NCT04936464
Brief Title
Transcutaneous Tibial Nerve Stimulation for Urgency Urinary Incontinence
Acronym
TTeNS
Official Title
Transcutaneous Tibial Nerve Stimulation for Urgency Urinary Incontinence: A Sham-Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 20, 2021 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente
Collaborators
American Urogynecologic Society

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urge Incontinence, Overactive Bladder
Keywords
tibial nerve stimulation, transcutaneous electrical nerve stimulation, overactive bladder, urgency urinary incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
99 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
30-minute treatments, twice weekly x12 weeks
Arm Title
Sham Group
Arm Type
Sham Comparator
Arm Description
30-minute treatments, twice weekly x12 weeks
Intervention Type
Device
Intervention Name(s)
transcutaneous tibial nerve stimulation (TTNS)
Intervention Description
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 Type
Device
Intervention Name(s)
transcutaneous electrical stimulation (TENS)
Intervention Description
The sham intervention is designed to appear almost identical to the TTNS intervention.
Primary Outcome Measure Information:
Title
Overactive Bladder Questionnaire (OAB-q)
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Voiding diary
Description
To evaluate the efficacy of a 12-week course of TTNS in reducing the frequency of UUI episodes in the intervention versus sham group.
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Incremental cost-effectiveness ratio (ICER)
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Trial is open to biologically female participants only as this is the target population of interest.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nemi M Shah, MD
Organizational Affiliation
University of California San Diego/Kaiser Permanente San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanente San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Transcutaneous Tibial Nerve Stimulation for Urgency Urinary Incontinence

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