Qualitative Assessment of the Impact of TTNS on QOL and Participation

January 28, 2026 updated by: Medstar Health Research Institute

Qualitative Assessment of the Impact of Transcutaneous Tibial Nerve Stimulation (TTNS) on Quality of Life and Participation

This study through the use of semi-structured interviews or focus groups will explore the lived experience with Transcutaneous Tibial Nerve Stimulation (TTNS) with Neurogenic Lower Urinary Tract Dysfunction to generate user-defined themes regarding bladder function and catheter-related barriers and the daily impacts on one's life.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Identify NLUTD user-defined themes regarding bladder function and and the daily impacts on one's life Specific Aim: Using iterative, semi-structured interviews or focus groups to explore the lived experience using TTNS neuromodulation to generate user-defined themes regarding bladder function and the daily impacts on one's life.

Study Type

Observational

Enrollment (Actual)

75

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
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • MedStar National Rehabilitation Hospital

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

We will purposively recruit consumers Y1-Y4 to explore their experience with bladder function, as well as NLUTD-related barriers and impact on one's life. Recruitment will be guided by a random sampling of patient characteristics to promote comprehensive sampling as follows: usual bladder management, and etiology of NLUTD (n=20).

Description

Inclusion:

Participated in TTNS Study for 1 year.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Subjects who used TTNS
Subjects will have Neurogenic Lower Urinary Tract Dysfunction and will have participated in a study with TTNS. n=20
Behavioral: Semi-structured interview
Using iterative, semi-structured interviews or focus groups to explore the lived experience with CC and usual customary care (UCC) of catheter users with NLUTD and their caretakers to generate user-defined themes regarding bladder function and catheter-related barriers and the daily impacts on one's life.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Consumer user-defined themes from qualitative interviews
Time Frame: Collected once at study completion at 1 year
Explore the lived experience using the transcutaneous tibial nerve stimulation to generate user-defined themes regarding bladder function and the daily impacts on one's life. Qualitative analysis will be used to define these themes about how TTNS impacted ones life, and bladder function
Collected once at study completion at 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Follow-up calls regarding user-defined themes
Time Frame: through study completion, an average of 1 year
Possible follow-up calls for clarification on user-defined themes (primary outcome) may need to be done to
through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Medstar Health Research Institute

Investigators

  • Principal Investigator: Emily Leonard, PhD, Medstar Health Research Institute

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)

May 31, 2022

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

January 27, 2020

First Submitted That Met QC Criteria

January 28, 2020

First Posted (Actual)

January 30, 2020

Study Record Updates

Last Update Posted (Actual)

January 30, 2026

Last Update Submitted That Met QC Criteria

January 28, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00004862

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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