Transcutaneous Tibial Nerve Stimulation for Urgency Urinary Incontinence

Overactive Bladder Clinical Trial

— TTeNS  

Official title:

Transcutaneous Tibial Nerve Stimulation for Urgency Urinary Incontinence: A Sham-Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04936464
• Other study ID #: 12791
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 20, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: October 2023
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 99
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Overactive Bladder
• Urge Incontinence
• Urinary Bladder, Overactive
• Urinary Incontinence
• Urinary Incontinence, Urge

Intervention

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.
• transcutaneous electrical stimulation (TENS)
The sham intervention is designed to appear almost identical to the TTNS intervention.

Locations

Country	Name	City	State
United States	Kaiser Permanente San Diego	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Kaiser Permanente	American Urogynecologic Society

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incremental cost-effectiveness ratio (ICER)	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.	12 weeks
Primary	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	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.	12 weeks