Biofeedback Therapy Versus Botox Injection in Treatment of Dyssynergic Defecation.

Phase 4

Completed

• Conditions: Obstructed Defaecation Syndrome
• Interventions: Device: Biofeedback therapy; Drug: Botulinum Toxin A (Botox )

• Registration Number: NCT06724250
• Lead Sponsor: Mansoura University

Brief Summary

assessment the Improvement symptoms of obstructed defecation after biofeedback training versus botulinum toxin injection

Detailed Description

This is a randomized controlled trial including 78 patients diagnosed with obstructed defecation syndrome confirmed by detailed history talking, full clinical examination, anorectal manometry and defecography.

Included patients divided into two equal groups: first group ( biofeedback therapy group) patients recieved biofeedback therapy for six sessions over one month, the second group:( botulinum toxin group) received botulinum toxin injection 100 IU in buborectalis muscle.

The primary outcome is improvement of symptoms after one year

Study Timeline

• Study Start: 2023-08-01
• Primary Completion: 2024-08-31
• Study Completion: 2024-09-30
• Status Verified: 2024-11
• Study First Submitted: 2024-11-29
• Study First Submitted QC: 2024-12-06
• Last Update Submitted: 2024-12-06
• Study First Posted: 2024-12-09
• Last Update Posted: 2024-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

• patients of both genders
• age of 18 years or older
• fulfillment of the Rome 3 constipation criteria for the past 3 months, symptom onset as a maximum six months prior to diagnosis, patients suffer from prolonged, incomplete and challenging evacuation

Exclusion Criteria

• Anismus cases with secondary reason for constipation
• patients who undergone anorectal surgery Patients with colonic inertia
• conditions that make biofeedback training impossible
• cases with primary illness causing constipation as hypothyroidism

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Biofeedback therapy group	Biofeedback therapy	Patients with dyssynergic defecation underwent biofeedback training program in the form of six sessions over one month
Botox injection group	Botulinum Toxin A (Botox )	Participants in this group received 100 international unit of botulinum toxin type A that was injected injections into the puborectalis muscle to alleviate dyssynergic defecation by reducing muscle overactivity and improving coordination.

Primary Outcome Measures

Name	Time	Method
Improvement of symptoms of constipation for one year follow up	One year	* Follow-up was conducted for about 1 year as regard the improvement in bowel habits.; * Patients was asked to fill up a symptom questionnaire (Wexner constipation score with a maximum score of 30 and a minimum of 0) following the therapeutic procedure The wexner constipation score : include 8-item questionnaire about bowel movements frequency, anal pain during evacuation, abdominal pain, incomplete evacuation, time taken for evacuation per attempt, number of attempts for a successful bowel movement in the previous 24 hours, type of assistance for defecation, and duration of constipation. All items are scored from 0 to 4 except for the "type of assistance for defecation," which is scored from 0 to 2.The clinical improvement was chosen when there was decrease in the score.

Secondary Outcome Measures

Name	Time	Method
Improvement of pain for one year follow up	One year	Pain improvement on the visual analogue scale is from 0 to 10, where 0 means no pain and 10 means the worst pain.

Trial Locations

Locations (1)

Mansoura faculty of medicine; 🇪🇬 Mansoura, Egypt