Electromyographic Biofeedback Therapy for Dyssynergic Defecation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study tests a game-based electromyographic biofeedback approach for people with dyssynergic defecation and chronic constipation. Participants receive EMG biofeedback therapy with a sham control to retrain pelvic floor muscle coordination. Outcomes include quality of life, sleep quality, constipation severity, and pelvic floor function. The trial compares active therapy to a sham procedure to determine the effect on symptoms and daily functioning. Recruitment is centered at Kocaeli University in Izmit, Turkey.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Diagnosis of dyssynergic defecation was confirmed by anorectal manometry, which demonstrated paradoxical pelvic floor muscle contraction and/or inadequate relaxation during defecation.
2. Eligibility for a pelvic floor rehabilitation program was based on a comprehensive evaluation conducted at the Physical Medicine and Rehabilitation Clinic.
3. Age between 18 and 70 years.
4. A history of chronic constipation lasting at least six months, in accordance with the Rome IV diagnostic criteria.
5. Stool consistency was classified as type 1 or type 2 according to the Bristol Stool Scale, indicating a hard stool pattern.

Exclusion Criteria:

1. Presence of communication barriers that may interfere with participation in the study.
2. Cognitive impairment affects the ability to comply with rehabilitation programs or assessments.
3. Pregnancy.
4. Presence of severe depression and/or anxiety disorder.
5. Untreated metabolic or endocrine disorders, including but not limited to diabetes mellitus, hypothyroidism, hypokalemia, and hypercalcemia.
6. Use of medications known to cause or exacerbate constipation.
7. History of spinal, rectal, or pelvic surgery, excluding cholecystectomy, hysterectomy, and appendectomy.
8. Presence of colorectal malignancy or inflammatory bowel disease.
9. Anorectal malformations or congenital pelvic floor anomalies.
10. Spina bifida, spinal cord injury, or neurological disorders, including multiple sclerosis, Parkinson's disease, dementia, or epilepsy.
11. Presence of severe cardiac or renal disease.
12. Advanced-stage hemorrhoids, anal fissures, or anal fistulas.

Where it's running

• Kocaeli University
  Kocaeli, Izmit, Turkey (Türkiye) Recruiting

Study contacts

• Study coordinator: Tugba Gokbel, Assistant Prof, MD
• Email: tugbagokbelftr@gmail.com
• Phone: +905442877390

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.