TTNS vs PTNS in a County Hospital System.

January 16, 2026 updated by: Tajnoos Yazdany, M.D., Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Assessment of Patient Satisfaction With Transcutaneous Tibial Nerve Stimulation in a County Hospital System

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Torrance, California, United States, 90509
        • Harbor UCLA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Percutaneous tibial nerve stimulation (PTNS)
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
neuromodulation therapy for overactive bladder that targets the posterior tibial nerve
Other Names:
  • PTNS
  • TTNS
Experimental: Transcutaneous tibial nerve stimulation (TTNS)
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
neuromodulation therapy for overactive bladder that targets the posterior tibial nerve
Other Names:
  • PTNS
  • TTNS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICIQ-OAB score
Time Frame: Baseline, 6 weeks, 12 weeks, 6 months post treatment initiation
OAB symptom severity
Baseline, 6 weeks, 12 weeks, 6 months post treatment initiation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction
Time Frame: 6 weeks, 12 weeks, 6 months post treatment initiation
Patient satisfaction with the intervention (Y/N; would you recommend it to others?)
6 weeks, 12 weeks, 6 months post treatment initiation
PGI-I
Time Frame: 6 weeks, 12 weeks, 6 months post treatment initiation
Patient global assessment of overall improvement, graded on a scale of 1-7
6 weeks, 12 weeks, 6 months post treatment initiation
Compliance
Time Frame: 6 months post treatment initiation
Number and percentage of PTNS visits (PTNS arm); Patient reported number of self-administered TTNS treatments per week
6 months post treatment initiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2017

Primary Completion (Actual)

April 30, 2018

Study Completion (Actual)

June 30, 2018

Study Registration Dates

First Submitted

January 16, 2026

First Submitted That Met QC Criteria

January 16, 2026

First Posted (Actual)

January 21, 2026

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 16, 2026

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-32833-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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