NCT06724250

Biofeedback Therapy Versus Botox Injection in Treatment of Dyssynergic Defecation.

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Mansoura University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Obstructed Defaecation Syndrome

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2023-08-01
• Primary completion: 2024-08-31
• Completion: 2024-09-30
• First posted: 2024-12-09
• Last updated: 2024-12-09

Locations

1 site across 1 country: Egypt

Regulatory

• FDA-regulated drug study
• FDA-regulated device study