NCT03595215: OAB Aim 2

Posterior Tibial Nerve Stimulation's Effectiveness in UI Frequency in Overactive Patients in Home

Completed NA Results posted Last updated 21 May 2021

What this trial tests

NA trial testing TENS in Overactive Bladder in 18 participants. Completed in 17 September 2019.

Timeline

10 September 2018

Primary endpoint
10 July 2019

17 September 2019

Quick facts

Lead sponsor	Theranova, L.L.C.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	18
Start date	10 September 2018
Primary completion	10 July 2019
Estimated completion	17 September 2019
Sites	1 location across United States

Drugs / interventions tested

• TENS

Conditions studied

• Overactive Bladder — all drugs for Overactive Bladder →

Sponsor

Theranova, L.L.C.

Who can join

Adults 55 to 100, female only, with Overactive Bladder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Urge Incontinence Episodes Primary · Baseline and 8 weeks

Group	Value	95% CI
TENS Treatment Arm	3.9	± 4.0

Change in Micturitions Per Day Secondary · Baseline and 8 weeks

Mean number of urinary voids per day (taken over a 3-day period)

Group	Value	95% CI
TENS Treatment Arm	5.6	± 13.9

Change in Health-related Quality of Life (HRQL) Secondary · Baseline and 8 weeks

Change in incontinence health-related quality of life (HRQL) scores compared to pre-treatment. The survey consists of 13 questions that can be scored from 1 to 6. Lower scores correspond with better quality of life. The lowest score possible is 13 and the highest is 78.

Group	Value	95% CI
TENS Treatment Arm	-19.5	± 14.5

Sponsor's own description

This pilot clinical study, which focuses on feasibility and proof-of-principle, will be conducted in 11 female subjects (55-100 years old) with UI. Subjects will use the device three times a week for 8 weeks and complete 3-day "voiding diaries" to record instances of UI episodes and OAB quality of life.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Pilot Study of a Novel At-Home Posterior Tibial Nerve System for Overactive Bladder Syndrome.
   Burton CS, Sokol ER. · · 2024 · cited 2× · PMID 37493289 · DOI 10.1097/spv.0000000000001399