Transcutaneous Tibial Nerve Stimulation for Urgency Urinary Incontinence

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-20

Study Completion Date

2024-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Tibial Transcutaneous Electrostimulation in Women with Urgency Urinary Incontinence

NCT05590481

Urinary Incontinence, Urge

COMPLETED NA

Electromagnetic Stimulation for the Treatment of Urge Urinary Incontinence and Overactive Bladder

NCT01464372

Urinary Incontinence, Urge

TERMINATED PHASE3

Comparison of the Efficacy of Transcutaneos Nerve Stimulations in Women With Idiopathic Overactive Bladder

NCT06349694

Urinary Bladder, Overactive

NOT_YET_RECRUITING NA

Comparison of the Effects of Transcutaneous Electrical Nerve Stimulation Protocols in Women With Overactive Bladder

NCT05672277

Overactive Bladder

UNKNOWN NA

Transcutaneous Peripheral Neuromodulation for Neurogenic Bladder

NCT02582151

Urinary Bladder, Neurogenic

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Urge Incontinence Overactive Bladder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention Group

30-minute treatments, twice weekly x12 weeks

Group Type EXPERIMENTAL

transcutaneous tibial nerve stimulation (TTNS)

Intervention Type 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.

Sham Group

30-minute treatments, twice weekly x12 weeks

Group Type SHAM_COMPARATOR

transcutaneous electrical stimulation (TENS)

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

transcutaneous electrical stimulation (TENS)

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No