NCT07390682

Obesity on the Efficacy of Bilateral Tibial Nerve Stimulation

Impact of Obesity on the Efficacy of Bilateral Tibial Nerve Stimulation in Obstructed Defecation

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: General Committee of Teaching Hospitals and Institutes, Egypt · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Obstructed defecation syndrome (ODS) is a common functional bowel disorder characterized by difficulty in stool evacuation. Bilateral posterior tibial nerve stimulation (BT PTNS) has emerged as a noninvasive, safe, and effective therapeutic option for functional ODS, improving symptom severity and quality of life.

Detailed description

Obesity is associated with altered pelvic floor mechanics, which may affect the response to neuromodulation therapy. However, the effect of obesity on BT PTNS outcomes in ODS has not been systematically evaluated. This study aims to fill this knowledge gap by comparing treatment efficacy between obese and non-obese patients.

Conditions

• Obstructed Defecation

Interventions

Type	Name	Description
PROCEDURE	Bilateral posterior tibial nerve stimulation	* Procedure: BT PTNS will be administered via transcutaneous electrodes placed bilaterally along the posterior tibial nerve at the medial malleolus. * Frequency: 3 sessions per week for 6 weeks (total of 18 sessions). * Duration per Session: 30 minutes. * Monitoring: Patients will be monitored for adverse events during and after each session.

Timeline

• Start date: 2026-02-01
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2026-02-05
• Last updated: 2026-02-05

Locations

1 site across 1 country: Egypt