Biofeedback Therapy Versus Botox Injection in Treatment of Dyssynergic Defecation.

Biofeedback Versus Botox Injection in Treatment of Dyssynergic Defecation (Randomized Controlled Trial)

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

Study Overview

• Status: Completed
• Conditions: Obstructed Defaecation Syndrome
• Intervention / Treatment: Device: Biofeedback therapy; Drug: Botulinum Toxin A (Botox )

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 Type: Interventional
• Enrollment (Actual): 78
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Mansoura, Egypt, 35516
    • Mansoura Faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Biofeedback therapy group; Patients with dyssynergic defecation underwent biofeedback training program in the form of six sessions over one month	Device: Biofeedback therapy; Biofeedback therapy involves the use of specialized equipment to provide real-time feedback on pelvic floor muscle activity. Participants are trained to improve muscle coordination and relaxation through guided exercises, targeting the resolution of dyssynergic defecation.
Active Comparator: 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.	Drug: Botulinum Toxin A (Botox ); Botulinum toxin is injected into the pelvic floor muscles to reduce muscle overactivity and improve coordination, aiming to relieve symptoms of dyssynergic defecation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of symptoms of constipation for one year follow up	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.	One year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Actual): August 31, 2024
• Study Completion (Actual): September 30, 2024

Study Registration Dates

• First Submitted: November 29, 2024
• First Submitted That Met QC Criteria: December 6, 2024
• First Posted (Estimated): December 9, 2024

Study Record Updates

• Last Update Posted (Estimated): December 9, 2024
• Last Update Submitted That Met QC Criteria: December 6, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Neurotransmitter Agents; Membrane Transport Modulators; Cholinergic Agents; Neuromuscular Agents; Acetylcholine Release Inhibitors; Botulinum Toxins, Type A; abobotulinumtoxinA; Botulinum Toxins
• Other Study ID Numbers: MS.23.090.2539

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes