Biofeedback Therapy Versus Botox Injection in Treatment of Dyssynergic Defecation.

NCT06724250 | Completed Phase 4 FDA Drug FDA Device

• 1 other identifier: MS.23.090.2539
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obstructed Defaecation Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Improvement of pain for one year follow up

  One year

Study Arms (2)

Biofeedback therapy group

ACTIVE COMPARATOR

Patients with dyssynergic defecation underwent biofeedback training program in the form of six sessions over one month

Device: Biofeedback therapy

Botox injection group

ACTIVE COMPARATOR

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 )

Interventions

Biofeedback therapy DEVICE

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.

Biofeedback therapy group

Botulinum Toxin A (Botox ) DRUG

Botulinum toxin is injected into the pelvic floor muscles to reduce muscle overactivity and improve coordination, aiming to relieve symptoms of dyssynergic defecation.

Botox injection group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura faculty of medicine

Al Mansurah, 35516, Egypt

Location

MeSH Terms

Interventions

Biofeedback, Psychology; Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological; Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2024
• First Posted: December 9, 2024
• Study Start: August 1, 2023
• Primary Completion: August 31, 2024
• Study Completion: September 30, 2024
• Last Updated: December 9, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

EG (1)