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

PHASE4Active, not recruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

July 31, 2021

Primary Completion Date

September 30, 2023

Study Completion Date

March 31, 2025

Conditions
Obstructed Defaecation SyndromeAnterior Rectocele
Interventions
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)

Trial Locations (1)

35516

Mansoura University Hospital, Al Mansurah

All Listed Sponsors
lead

Mansoura University

OTHER