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Enrolling By Invitation NCT07622732

Biofeedback for Women With Dyssynergic Defecation (DD)

Conditions: Dyssenergic Defecation, Straining, Hard Stools, Incomplete Evacuation

Sex: Female
Ages: 35 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 58
Sponsor: Ahram Canadian University

Location: Ahram Canadian University Giza Cairo Governorate

Summary

This research aimed to compare the effect of Biofeedback (BFB) versus Lifestyle management in form of stretching positions and patient's education position of defecation, in addition to rectal massage, and anal dilators among Dyssynergic Defecation (DD) in Females. It is common and affects up to one half of patients with chronic constipation. This acquired behavioral problem is due to the inability to coordinate the abdominal and pelvic floor muscles to evacuate stools

Eligibility Criteria

Inclusion Criteria: * Female patients aged between 35-65 years, their BMI 30-34 kg/m2, they are suffering from DD, have ability to perform BFB, and cooperative and capable of providing informed consent. namely two or more of 6 symptoms present for the last 3 months with an onset more than 6 months in the past; the symptoms are: straining, lumpy or hard stools, sensation of incomplete evacuation, sensation of anorectal obstruction/blockage, or manual manoeuvres to facilitate defecation, or less than 3 bowel movements per week. All the included patients will have selected to be unresponsive to dietary modification, life style modification, and laxatives for a period of at least 3 months. Exclusion Criteria: * Significant anatomical issues such as a large rectocele, full rectal prolapse, active anal fissures, severe internal anal sphincter injuries, or anorectal neoplasia, history of recent anal region surgery (e.g., within the last 6 months), history of previous gastrointestinal, spinal, or pelvic surgery, neurological diseases that affect bowel function, such as multiple sclerosis, stroke, spinal cord injury, or Parkinson's disease, severe cardiac, renal, or chronic obstructive pulmonary disease (COPD), inflammatory bowel disease (Crohn's disease or ulcerative colitis), diabetes mellitus, or thyroid dysfunction. Use of opioids within a specified recent period (e.g., the previous 2 weeks or not on a stable dose). Use of medications known to cause constipation or interfere with the study, such as certain antidepressants or analgesics. Recent history (e.g., within 6 months) of Botox injections for pelvic floor issues. Pregnancy, Impaired cognition or mental health issues (e.g., severe depression, psychotic disorders, cognitive disability) that would prevent understanding and cooperation with the treatment. Alternating patterns of constipation and diarrhea, which may indicate Irritable Bowel Syndrome (IBS) without a clear constipation subtype.

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Source: ClinicalTrials.gov (NCT07622732). StuddyBuddy aggregates publicly available trial information.