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

Mansoura University

Status and phase: Active, not recruiting; Phase 4

Conditions: Anterior Rectocele; Obstructed Defaecation Syndrome

Treatments: Procedure: Transvaginal repair & distilled water injection; Drug: Transvaginal repair & botulinum toxin type A injection

Study type: Interventional

Funder types: Other

Identifiers

NCT06804993

MD.21.03.441

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Transvaginal repair & botulinum toxin type A toxin injection

Experimental group

Treatment:

Drug: Transvaginal repair & botulinum toxin type A injection

Transvaginal repair & distilled water injection

Placebo Comparator group

Treatment:

Procedure: Transvaginal repair & distilled water injection