Qualitative Assessment of the Impact of TTNS on QOL and Participation

NCT ID: NCT04248322

Last Updated: 2024-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-31

Study Completion Date

2025-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Neurogenic Bladder Urinary Retention Urinary Tract Infections Spinal Cord Injuries

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Subjects who used TTNS

Subjects will have Neurogenic Lower Urinary Tract Dysfunction and will have participated in a study with TTNS. n=20

Semi-structured interview

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

Participated in TTNS Study for 1 year.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medstar Health Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emily Leonard, PhD

Role: PRINCIPAL_INVESTIGATOR

Medstar Health Research Institute

Locations

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MedStar National Rehabilitation Hospital

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

Site Status RECRUITING

Countries

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United States

Central Contacts

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Emily Leonard, PhD

Role: CONTACT

202 877-1844

Facility Contacts

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Emily Leonard, PhD

Role: primary

202-877-1844

Inger Ljungberg, MPH

Role: backup

202 877-1694

Other Identifiers

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STUDY00004862

Identifier Type: -

Identifier Source: org_study_id

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