NCT07353944

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 18, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
7.6 years until next milestone

First Submitted

Initial submission to the registry

January 16, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 21, 2026

Completed
Last Updated

January 21, 2026

Status Verified

March 1, 2019

Enrollment Period

1.3 years

First QC Date

January 16, 2026

Last Update Submit

January 16, 2026

Conditions

Overactive Bladder

Keywords

overactive bladderOABPTNSpercutaneous tibial nerve stimulationTTNStranscutaneous tibial nerve stimulationcounty hospitalunderserved

Outcome Measures

Primary Outcomes (1)

  • ICIQ-OAB score

    OAB symptom severity

    Baseline, 6 weeks, 12 weeks, 6 months post treatment initiation

Secondary Outcomes (3)

  • Patient satisfaction

    6 weeks, 12 weeks, 6 months post treatment initiation

  • PGI-I

    6 weeks, 12 weeks, 6 months post treatment initiation

  • Compliance

    6 months post treatment initiation

Study Arms (2)

Percutaneous tibial nerve stimulation (PTNS)

ACTIVE COMPARATOR

Participants undergo weekly 30-minute percutaneous tibial nerve stimulation in our clinic. The PTNS device is a neuromodulation system comprised of an external signal generator attached to one electrode that is placed on the patient's foot, and the other to an acupuncture needle that is inserted in the patient's inner ankle. It delivers a low electrical signal (20 Hz, 200ms pulse width) to the posterior tibial nerve, adjusted to the participant's perception of stimulation without pain.

Device: Tibial nerve stimulation

Transcutaneous tibial nerve stimulation (TTNS)

EXPERIMENTAL

Participants receive a TENS unit and are taught how to conduct TTNS therapy at home at their recruitment visit. The TENS unit is a neuromodulation system comprised of an external signal generator attached to one electrode that is placed on the patient's foot, and the other to an electrode patch that is inserted in the patient's inner ankle. It delivers a low electrical signal (20 Hz, 200ms pulse width) to the posterior tibial nerve, adjusted to the participant's perception of stimulation without pain. They will be instructed to conduct this therapy every other day at home.

Device: Tibial nerve stimulation

Interventions

Tibial nerve stimulationDEVICE

neuromodulation therapy for overactive bladder that targets the posterior tibial nerve

Also known as: PTNS, TTNS
Percutaneous tibial nerve stimulation (PTNS)Transcutaneous tibial nerve stimulation (TTNS)

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • cognitive impairment or diagnosis of dementia
  • diagnosis of neurogenic bladder
  • prior midurethral sling procedure
  • use of an electronic pacemaker
  • current pregnancy
  • incarcerated persons

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harbor UCLA Medical Center

Torrance, California, 90509, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
After randomization, patients and care providers will not be blinded, however investigators will be blinded to the results of the survey instruments.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized control trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 16, 2026

First Posted

January 21, 2026

Study Start

January 18, 2017

Primary Completion

April 30, 2018

Study Completion

June 30, 2018

Last Updated

January 21, 2026

Record last verified: 2019-03

Locations

US(1)