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

NCT06804993 | Active Not Recruiting Phase 4

• 1 other identifier: MD.21.03.441
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Recurrence rate

  One year

Study Arms (2)

Transvaginal repair & botulinum toxin type A toxin injection

EXPERIMENTAL

Drug: Transvaginal repair & botulinum toxin type A injection

Transvaginal repair & distilled water injection

PLACEBO COMPARATOR

Procedure: Transvaginal repair & distilled water injection

Interventions

Transvaginal repair & botulinum toxin type A injection DRUG

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 & botulinum toxin type A toxin injection

Transvaginal repair & distilled water injection PROCEDURE

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)

Transvaginal repair & distilled water injection

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• female patients
• symptomatic rectocele
• failed conservative treatments for at least 3 months
• anterior rectocele larger than 3 cm in size in defecogram.
• retention of the contrast in the rectocele on defecography
• obstructed defecation manifestations: excessive straining, a sense of incomplete evacuation, the need for digital manipulation during defecation, or dyspareunia

You may not qualify if:

• significant urinary manifestations due to anterior vaginal wall prolapse
• recurrent rectocele
• previous anal surgery
• slow-transit constipation
• faecal incontinence (FI)
• abnormal thyroid functions
• patients under systemic steroid treatment
• patients with connective tissue disease
• ASA classification \>3

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University Hospital

Al Mansurah, 35516, Egypt

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor & Consultant Colorectal Surgeon

Study Record Dates

• First Submitted: January 28, 2025
• First Posted: February 3, 2025
• Study Start: July 31, 2021
• Primary Completion: September 30, 2023
• Study Completion: March 31, 2025
• Last Updated: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)