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Qualitative Assessment of the Impact of TTNS on QOL and Participation

Sponsor
Medstar Health Research Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT04248322
Collaborator
(none)
20
Enrollment
1
Location
28.1
Anticipated Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Semi-structured interview

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 Design

Study Type:
Observational
Anticipated Enrollment :
20 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Qualitative Assessment of the Impact of Transcutaneous Tibial Nerve Stimulation (TTNS) on Quality of Life and Participation
Actual Study Start Date :
May 31, 2022
Anticipated Primary Completion Date :
Oct 1, 2024
Anticipated Study Completion Date :
Oct 1, 2024

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Consumer user-defined themes from qualitative interviews [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 Outcome Measures

  1. Follow-up calls regarding user-defined themes [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion:

Participated in TTNS Study for 1 year.

Contacts and Locations

Locations

Site City State Country Postal Code
1 MedStar National Rehabilitation Hospital Washington District of Columbia United States 20010

Sponsors and Collaborators

  • Medstar Health Research Institute

Investigators

  • Principal Investigator: Amanda K Rounds, PhD, Medstar Health Research Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Medstar Health Research Institute
ClinicalTrials.gov Identifier:
NCT04248322
Other Study ID Numbers:
  • STUDY00004862
First Posted:
Jan 30, 2020
Last Update Posted:
Jul 13, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Medstar Health Research Institute
Quality of Life
Participation
Barrier
Additional relevant MeSH terms:
Urinary Tract Infections
Spinal Cord Injuries
Urinary Bladder, Neurogenic
Urinary Retention

Study Results

No Results Posted as of Jul 13, 2022