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Observation of the Clinical Efficacy of Selective Serotonin Reuptake Inhibitors (SSRIs) in puborectalis muscle relaxation-deficient type of defecation: A Prospective,Multicenter, Randomized Controlled Trial

Observation of the Clinical Efficacy of Selective Serotonin Reuptake Inhibitors (SSRIs) in puborectalis muscle relaxation-deficient type of defecation: A Prospective,Multicenter, Randomized Controlled Trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400080264
Enrollment
Unknown
Registered
2024-01-24
Start date
2024-02-01
Completion date
Unknown
Last updated
2024-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

puborectalis muscle relaxation-deficient type of defecation

Interventions

Experimental group:Fluoxetine hydrochloride capsules
Control group:Starch capsules
Treatment failure group:Fluoxetine hydrochloride capsule treatment was ineffective, and polyethylene glycol electrolyte powder was used for symptomatic treatment

Sponsors

Ningxia Hui Autonomous Region People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1)Symptoms of difficulty in defecation must have persisted for at least 6 months. 2)In the past 3 months, at least 25% of bowel movements must be accompanied by features indicative of pelvic floor dyssynergia. Features of pelvic floor dyssynergia include: Difficulty in defecation: Straining or exertion during bowel movements, prolonged duration of bowel movements, sensation of incomplete evacuation, etc. Constipation: Reduced frequency of bowel movements, increased intervals between bowel movements, dry and hard stool consistency, etc. At least one of the following examinations (pelvic floor electromyography (EMG), (dynamic) magnetic resonance defecography, and barium enema) should indicate concentrated features: Pelvic floor muscle tension: Excessive tension in pelvic floor muscles leading to difficulty in defecation. Inability of pelvic floor muscles to relax: Impaired relaxation of the pelvic floor muscles affecting defecation. Pelvic floor muscle dysfunction: Weakness in muscles, coordination issues, etc. 3)All subjects must undergo screening by departments of digestive surgery, psychosomatic medicine, and radiology. 4)Presence of anxiety or depression as assessed by a psychiatrist or psychologist. 5)Participants must willingly and knowingly agree to participate, and provide signed informed consent.

Exclusion criteria

Exclusion criteria: 1)Individuals with constipation caused by opioid medications. 2)Those with organic intestinal diseases diagnosed through electronic colonoscopy or barium enema. 3)Women who are breastfeeding or pregnant. 4)Participants who have received treatment with neuroregulators in the three months prior to enrollment. 5)Individuals assessed as incapable of self-care based on activities of daily living assessment.

Design outcomes

Primary

MeasureTime frame
Patient symptom self-rating scale;

Secondary

MeasureTime frame
Magnetic resonance defecography (MRD);Electromyography (EMG);Barium enema;Constipation Patient Lifestyle Assessment Scale;Kess Scale;Generalized Anxiety Disorder Scale (GAD-7);Patient Health Questionnaire-9 (PHQ-9);Patient Health Questionnaire-15 (PHQ-15);

Countries

China

Contacts

Public ContactLi Xuzhao

Ningxia Hui Autonomous Region People's Hospital

lixvzhao2022@163.com+86 187 9538 1479

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026