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OpenTrials
Completed

NCT Number: NCT07353944

TTNS vs PTNS 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

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Key information

Conditions

Overactive Bladder Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Harbor UCLA Medical Center

Torrance, California, 90509, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tibial Nerve Stimulation

Device

neuromodulation therapy for overactive bladder that targets the posterior tibial nerve

Other names: PTNS, TTNS

Primary outcomes

  1. ICIQ-OAB score

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

    OAB symptom severity

Secondary outcomes

  1. 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?)

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 21, 2026
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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