Qualitative Assessment of the Impact of TTNS on QOL and Participation

NCT04248322 | Active Not Recruiting

• 1 other identifier: STUDY00004862
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spinal Cord Injuries; Neurogenic Bladder; Urinary Retention; Urinary Tract Infections

Keywords

Quality of Life; Participation; Barrier

Outcome Measures

Primary Outcomes (1)

• Consumer user-defined themes from qualitative interviews

  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 Outcomes (1)

• Follow-up calls regarding user-defined themes

  through study completion, an average of 1 year

Study Arms (1)

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

Interventions

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.

Subjects who used TTNS

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• Participated in TTNS Study for 1 year.

Sponsors & Collaborators

• Medstar Health Research Institute: lead

Study Sites (1)

MedStar National Rehabilitation Hospital

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

Location

MeSH Terms

Conditions

Urinary Bladder, Neurogenic; Urinary Retention; Urinary Tract Infections; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

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

Study Officials

• Emily Leonard, PhD

  Medstar Health Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2020
• First Posted: January 30, 2020
• Study Start: May 31, 2022
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)