Rectocele Repair with or Without Internal Sphincter Botulinum Toxin Injection: a Prospective Randomized Trial
Phase 4
Active, not recruiting
- Conditions
- Obstructed Defaecation SyndromeAnterior Rectocele
- Interventions
- Drug: Transvaginal repair & botulinum toxin type A injectionProcedure: Transvaginal repair & distilled water injection
- Registration Number
- NCT06804993
- Lead Sponsor
- Mansoura University
- Brief Summary
This is a single-centre, prospective randomized controlled trial on female patients with anterior rectocele associated with obstructed defecation syndrome
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 60
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Transvaginal repair & botulinum toxin type A toxin injection Transvaginal repair & botulinum toxin type A injection - Transvaginal repair & distilled water injection Transvaginal repair & distilled water injection -
- Primary Outcome Measures
Name Time Method Recurrence rate One year
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie botulinum toxin type A's effect on internal sphincter dysfunction in rectocele repair?
How does transvaginal rectocele repair with botulinum toxin compare to standard-of-care surgical interventions for obstructed defecation syndrome?
Which anorectal manometry biomarkers predict response to botulinum toxin injection in anterior rectocele patients?
What are the long-term adverse event profiles of botulinum toxin versus placebo injection in pelvic floor reconstructive surgery?
How do combination therapies like botulinum toxin and sacral nerve stimulation compare for obstructed defecation syndrome management?
Trial Locations
- Locations (1)
Mansoura University Hospital
🇪🇬Mansoura, Egypt