Qualitative Assessment of the Impact of TTNS on QOL and Participation

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04248322

Enrollment

Registered

2020-01-30

Start date

2022-05-31

Completion date

2026-09-01

Last updated

2026-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Quality of Life, Participation, Barrier

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.

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.

Interventions

BEHAVIORALSemi-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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

Inclusion: Participated in TTNS Study for 1 year.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

United States

Contacts

PRINCIPAL_INVESTIGATOREmily Leonard, PhD

Medstar Health Research Institute

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 12, 2026