Biofeedback Versus Botox Injection in Treatment of Dyssynergic Defecation (Randomized Controlled Trial)
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Mansoura University
- Enrollment
- 78
- Locations
- 1
- Primary Endpoint
- Improvement of symptoms of constipation for one year follow up
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Biofeedback therapy group
Patients with dyssynergic defecation underwent biofeedback training program in the form of six sessions over one month
Intervention: Biofeedback therapy (Device)
Botox injection group
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.
Intervention: Botulinum Toxin A (Botox ) (Drug)
Outcomes
Primary Outcomes
Improvement of symptoms of constipation for one year follow up
Time Frame: 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 Outcomes
- Improvement of pain for one year follow up(One year)