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Recruiting
NCT07482696
Electromyographic Biofeedback Therapy in Patients With Dyssynergic Defecation
Conditions: Defecation Disorder
Sex: All
Ages: 18 Years – 70 Years
Healthy volunteers: No
Phase: NA
Enrollment: 36
Sponsor: Kocaeli University
Location: Kocaeli University Kocaeli Izmit
Summary
This study aimed to investigate the effects of game-based electromyographic (EMG) biofeedback therapy on the quality of life and sleep quality of individuals diagnosed with dyssynergic defecation.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07482696). StuddyBuddy aggregates publicly available trial information.