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Study Comparing Biofeedback Therapy and Pelvic Floor Muscle Training in Patients with Constipation Due to Difficulty in Defecation

Assessment of Efficacy of Biofeedback Versus Pelvic Floor Muscle Training in Patients with Constipation having Dyssynergic Defecation: A Randomized controlled Trial Using Block Randomization - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/05/110844
Enrollment
66
Registered
2026-05-21
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Health Condition 1: K590- Constipation

Interventions

Intervention1: Biofeedback Therapy: Computer software-based manometry-guided biofeedback therapy including pelvic floor relaxation training, coordination training and simulated evacuation training. Ma

Sponsors

Dr Suraj Bhagat
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age 18 to 75 years. Fulfilling Rome IV criteria for functional constipation alone or IBS with Constipation or both. Dyssynergic defecation confirmed by high resolution anorectal manometry and balloon expulsion test. Willingness to provide informed written consent.

Exclusion criteria

Exclusion criteria: Structural anorectal abnormalities. History of colorectal surgery. Secondary constipation due to metabolic, endocrine, drug-induced, neurological or malignant causes. Pregnancy. Severe psychiatric illness impairing participation or patients on psychiatric medications during past 3 months.

Design outcomes

Primary

MeasureTime frame
Reduction in Cleveland Constipation ScoreTimepoint: 3 months—

Secondary

MeasureTime frame
Change in Visual Analogue ScaleTimepoint: 3 months;Change in SF- 36 Quality of Life ScoreTimepoint: 3 months;Change in anorectal manometry parametersTimepoint: 3 months;Risk factors associated with poor responseTimepoint: 3 months—

Countries

India

Contacts

Public ContactDr. Ishaan Hriday Darbari

Department of Medical Gastroenterology, Amrita Hospital, Faridabad

ishaan.hd@fbd.amrita.edu9958470011

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026