Biofeedback Therapy Versus Botox Inject… | Clinical Trial

Key information

Conditions

Obstructed Defaecation Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mansoura faculty of medicine

Al Mansurah, 35516, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

Improvement of symptoms of constipation for one year follow up

Time frame: One year
- 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.

Secondary outcomes

Improvement of pain for one year follow up

Time frame: One year

Pain improvement on the visual analogue scale is from 0 to 10, where 0 means no pain and 10 means the worst pain.

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: Dec 9, 2024
Registry last updated: Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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