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NCT Number: NCT06804993

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Obstructed Defaecation Syndrome Anterior Rectocele

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Mansoura University Hospital

Al Mansurah, 35516, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

all required

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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 & 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)

Primary outcomes

  1. Recurrence rate

    Time frame: One year

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2025
First posted
Feb 3, 2025
Registry last updated
Feb 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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