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NCT Number: NCT04248322

Qualitative Assessment of the Impact of TTNS on QOL 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Neurogenic Bladder Central Nervous System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Urinary Bladder Diseases Urinary Bladder, Neurogenic Urinary Retention Urinary Tract Infections Urination Disorders Urogenital Diseases Urologic Diseases Wounds and Injuries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

MedStar National Rehabilitation Hospital

Washington D.C., District of Columbia, 20010, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion:

Participated in TTNS Study for 1 year.

Treatment and study plan

Semi-structured interview

Behavioral

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Medstar Health Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jan 30, 2020
Registry last updated
Jan 30, 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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