Management of Dyssynergic Defecation
Part of paid clinical trials in Rochester, Minnesota.
- Sponsor
- Mayo Clinic
- Study ID
- NCT07225803
- Status
- Recruiting
Conditions
- Constipation
- Dyssynergic Defecation
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 80 Years
- Healthy Volunteers
- Not accepted
Interventions
- Biofeedback — BEHAVIORALDuring anorectal biofeedback therapy, subjects are coached to improve abnormal patterns while observing activity recorded by manometry and/or surface EMG (electromyography) on a computer monitor while seated on a chair or a commode.
- Inspiratory muscle training (IMT) — BEHAVIORALSubjects will engage in inspiratory muscle training (IMT) that is tailored to the baseline performance of the individual.
Study Details
The purpose of this research is to better understand constipation and improve biofeedback treatments.
Key Dates
- Start date
- Jul 18, 2025
- Status verified
- Oct 2025
- Primary completion
- Jul 31, 2028
- Completion
- Jul 31, 2029
Study Design
- Enrollment
- 200 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Biofeedback and inspiratory muscle training (BFT Plus)Subjects in the BFT Plus arm will participate in a minimum of 6 up to a maximum of 20 biofeedback sessions, with each session lasting approximately 60 minutes. In addition, subjects will engage in inspiratory muscle training (IMT) at home.
- Active Comparator: Biofeedback only (BFT Alone)Subjects in the BFT Plus arm will participate in a minimum of 6 up to a maximum of 20 biofeedback sessions, with each session lasting approximately 60 minutes.
Primary Outcome Measure
Change in rectoanal gradient during evacuation [ Time Frame: Baseline, through study completion, an average of 16 weeks ]
Central Contacts
- Kelly J. Feuerhak, RN, CCRP507-255-6802
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 |
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