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Clinical Trials in Egypt / NCT06804993
Active, not recruiting Phase 4

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

NCT06804993 · tracked via the Priya Life Science Egypt tracker
Sponsor
Mansoura University
Phase
Phase 4
Started
2021-07-31
Last updated
2025-02-03

Condition(s) studied

Obstructed Defaecation SyndromeAnterior Rectocele

Investigational drug(s) / intervention(s)

Transvaginal repair & botulinum toxin type A injectionTransvaginal repair & distilled water injection

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)

Study summary

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

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Recurrence rate — One year

Trial sites (1)

FacilityCityRegionStatus
Mansoura University Hospital Al Mansurah Egypt

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06804993 on ClinicalTrials.gov ↗ ← All trials in Egypt