Obstructed Defaecation Syndrome
Conditions
Brief 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
Interventions
DEVICEBiofeedback 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.
Botulinum toxin is injected into the pelvic floor muscles to reduce muscle overactivity and improve coordination, aiming to relieve symptoms of dyssynergic defecation.
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of symptoms of constipation for one year follow up | 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
| Measure | Time frame | Description |
|---|---|---|
| Improvement of pain for one year follow up | 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. |
Countries
Egypt
Outcome results
None listed