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Rectocele Repair with or Without Internal Sphincter Botulinum Toxin Injection: a Prospective Randomized Trial
Sponsor: Mansoura University
Summary
This is a single-centre, prospective randomized controlled trial on female patients with anterior rectocele associated with obstructed defecation syndrome
Key Details
Gender
FEMALE
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2021-07-31
Completion Date
2025-03-31
Last Updated
2025-02-03
Healthy Volunteers
No
Interventions
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)
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)
Locations (1)
Mansoura University Hospital
Al Mansurah, Egypt