TTNS vs PTNS in a County Hospital System.

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center70 enrolled

Overview

The goal of this clinical trial is to study whether transcutaneous tibial nerve stimulation (TTNS) is a feasible and satisfactory treatment for overactive bladder in Urogynecology patients who receive their care at a county hospital. Researchers will compare outcomes with TTNS to patients who undergo percutaneous tibial nerve stimulation (PTNS). The main questions it aims to answer are: * Is TTNS non-inferior to PTNS in terms of OAB symptom severity? * Are patients as satisfied with TTNS as they are with PTNS? * Are patients' symptoms improved with TTNS? Participants will: * either undergo PTNS or be taught how to do TTNS therapy at home * complete surveys about their bladder symptoms and satisfaction with treatment

Patients who consent to this study will be randomly assigned to either receive PTNS in clinic weekly, or TTNS every other day at home. The severity of their overactive bladder symptoms and satisfaction with treatment will be assessed before starting treatment as well as 6 weeks, 12 weeks and 6 months after starting treatment. The results of these surveys will be compared between groups to determine whether TTNS is non-inferior to PTNS in this particular patient population.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Overactive Bladder

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * age between 18 - 90 years old * patient of the Urogynecology clinic at Harbor UCLA medical center * diagnosis of overactive bladder * patient elects non-pharmacologic treatment of overactive bladder * English or Spanish speaking * able to consent and participate in research Exclusion Criteria: * cognitive impairment or diagnosis of dementia * diagnosis of neurogenic bladder * prior midurethral sling procedure * use of an electronic pacemaker * current pregnancy * incarcerated persons

Outcomes

Primary Outcomes

ICIQ-OAB score

OAB symptom severity

Time frame: Baseline, 6 weeks, 12 weeks, 6 months post treatment initiation

Secondary Outcomes

Patient satisfaction

Patient satisfaction with the intervention (Y/N; would you recommend it to others?)

Time frame: 6 weeks, 12 weeks, 6 months post treatment initiation

PGI-I

Patient global assessment of overall improvement, graded on a scale of 1-7

Time frame: 6 weeks, 12 weeks, 6 months post treatment initiation

Compliance

Number and percentage of PTNS visits (PTNS arm); Patient reported number of self-administered TTNS treatments per week

Time frame: 6 months post treatment initiation