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Biofeedback Therapy Versus Botox Injection in Treatment of Dyssynergic Defecation.

NCT ID: NCT06724250

Last Updated: 2024-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2024-09-30

Brief Summary

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

Detailed Description

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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

Conditions

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Obstructed Defaecation Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Biofeedback therapy group

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

Group Type ACTIVE_COMPARATOR

Biofeedback therapy

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Botulinum Toxin A (Botox )

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Mansoura faculty of medicine

Al Mansurah, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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MS.23.090.2539

Identifier Type: -

Identifier Source: org_study_id