TTNS in SCI Patients With Neurogenic Detrusor Overactivity

Sponsor
National University Hospital, Singapore
Study ID
NCT07785258
Status
Not Yet Recruiting

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Conditions

  • Neurogenic Detrusor Overactivity
  • Spinal Cord Injuries

Eligibility Criteria

Sex
ALL
Age
21 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • TTNS — DEVICE
    Participants will undergo 28 sessions of TTNS in 4 weeks. TTNS will be administered using a neuromodulation device - Tensi+.

Study Details

This is a prospective, single-arm, pilot study to assess effectiveness and tolerability of transcutaneous tibial nerve stimulation (TTNS) in managing neurogenic detrusor overactivity in spinal cord injury patients. 12 - 16 spinal cord injury patients with neurogenic detrusor overactivity will be recruited. The intervention includes administration of TTNS at the highest tolerated level for 20 minutes daily for 4 weeks, using a neuromodulation device -- Tensi+. Outcome measures including Urodynamic Study (UDS) will be retrieved or collected at baseline and collected after the 4 weeks of TTNS administration. Other outcome measures include Overactive Bladder Questionnaire Short Form (OAB-Q-SF), which will be administered before and after TTNS administration, subject's level of discomfort and any adverse events experienced by the subject will be recorded after each intervention session and a bladder diary will be recorded weekly for subjects not on indwelling urinary catheters. A TTNS satisfaction survey will also be performed at the end of the study.

Key Dates

First listed
Aug 25, 2026
Start date
Sep 1, 2026
Status verified
Sep 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: transcutaneous tibial nerve stimulation
    28 sessions of transcutaneous tibial nerve stimulation (TTNS) in 4 weeks

Primary Outcome Measure

Maximum Cystometric Capacity (MCC) [ Time Frame: Week 0 ]

Central Contacts

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