NCT06804993

Rectocele Repair with or Without Internal Sphincter Botulinum Toxin Injection: a Prospective Randomized Trial

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Mansoura University · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a single-centre, prospective randomized controlled trial on female patients with anterior rectocele associated with obstructed defecation syndrome

Conditions

• Obstructed Defaecation Syndrome
• Anterior Rectocele

Interventions

Type	Name	Description
DRUG	Transvaginal repair & botulinum toxin type A injection	100 units of lyophilized botulinum toxin type A were diluted in saline to 50 U/mL before the injections. A total of 30 units of type-A botulinum toxin was injected with a 22-G needle evenly divided in 3 sites, 2 on either side of the internal anal sphincter (3 and 9 O'clock) and the third anteriorly (at 12 O'clock)
PROCEDURE	Transvaginal repair & distilled water injection	A total of 30 units of distilled water was injected with a 22-G needle evenly divided into 3 sites, 2 on either side of the internal anal sphincter (3 and 9 O'clock) and the third anteriorly (at 12 O'clock)

Timeline

• Start date: 2021-07-31
• Primary completion: 2023-09-30
• Completion: 2025-03-31
• First posted: 2025-02-03
• Last updated: 2025-02-03

Locations

1 site across 1 country: Egypt