Biofeedback Therapy Versus Botox Injection in Treatment of Dyssynergic Defecation.

Mansoura University

Status and phase: Completed; Phase 4

Conditions: Obstructed Defaecation Syndrome

Treatments: Drug: Botulinum Toxin A (Botox ); Device: Biofeedback therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06724250

MS.23.090.2539

Details and patient eligibility

About

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

Full 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

Enrollment: 78 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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78 participants in 2 patient groups

Biofeedback therapy group

Active Comparator group

Description:

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

Treatment:

Device: Biofeedback therapy

Botox injection group

Active Comparator group

Description:

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.

Treatment:

Drug: Botulinum Toxin A (Botox )