Defining the Safety and Efficacy of POSterIor Tibial NeRve StimulatiON in Children

Sponsor
Chi Dang Hornik
Study ID
NCT06769854
Phase
PHASE4
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Overactive Bladder
  • Overactive Bladder Syndrome

Eligibility Criteria

Sex
ALL
Age
5 Years - 21 Years
Healthy Volunteers
Accepted

Interventions

  • Urgent PC — DEVICE
    PTNS is a technique of electrical neuromodulation used primarily for treating OAB. The procedure for PTNS consists of the insertion of a fine needle above the medial malleolus near the posterior tibial nerve followed by the application of low-voltage electrical stimulation that produces sensory and motor responses.

Study Details

The purpose of this study is to find out if overactive bladder (OAB) can be safely treated by stimulating a nerve near the ankle. This procedure is called percutaneous tibial nerve stimulation (PTNS). It will be done by a device called the Urgent PC. The Urgent PC works by sending weak electrical signals through a thin needle to the nerve near the ankle. Stimulating this nerve may change bladder control.

Key Dates

First listed
Jan 10, 2025
Start date
Apr 1, 2027
Status verified
Jun 2026
Primary completion
May 31, 2029
Completion
Oct 31, 2029

Study Design

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

Arms

  • Experimental: Single-Arm Cohort
    Single Arm Cohort: (n=50) PTNS treatment weekly over 30 minutes for a total of 12 weekly sessions.

Primary Outcome Measure

The frequency of select safety Events of Special Interest. [ Time Frame: Weekly, Week 1 through Week 16 ]

Central Contacts

Related Studies