Treating dyssynergic defecation and constipation
Management of Dyssynergic Defecation
This trial tests whether biofeedback therapy, with or without inspiratory muscle training, helps adults with dyssynergic defecation or chronic constipation improve bowel function.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT07225803 on ClinicalTrials.gov |
What this trial studies
This interventional project enrolls adults aged 18–80 who meet Rome III criteria for functional constipation or IBS and have objective dyssynergic defecation on anorectal testing. Participants receive biofeedback therapy and some will also perform inspiratory muscle training as an adjunct to retrain pelvic floor and breathing mechanics. Researchers will collect anorectal physiological measures and patient-reported bowel symptoms before and after treatment to compare outcomes. The goal is to better understand constipation mechanisms and refine non-drug therapies to improve symptom control.
Who should consider this trial
Good fit: Adults 18–80 who meet Rome III criteria for functional constipation or IBS and have objective dyssynergic defecation on anorectal testing are the intended participants.
Not a fit: Patients with major structural anorectal abnormalities, recent significant abdominal surgery, active anal fissure, or serious comorbid conditions are unlikely to benefit or to be eligible for this intervention.
Why it matters
Potential benefit: If successful, the approach could improve coordination of the pelvic floor and reduce constipation symptoms using non-pharmacologic therapies.
How similar studies have performed: Biofeedback has demonstrated benefit for dyssynergic defecation in prior trials, while using inspiratory muscle training as an adjunct is a less-studied, more novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Men and women aged 18-80 years who are able and willing to provide written informed consent and to comply with the requirements for the entire study * Satisfy Rome III criteria for functional constipation and/or irritable bowel syndrome as assessed by questionnaires and objective evidence of dyssynergic defecation on anorectal testing Exclusion Criteria: * Clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric or other diseases that may interfere with the objectives of the study and/or pose safety concerns. * History of total, hemi- or subtotal colectomy at any time or other abdominal operations within 60 days prior to entry into the study. Segmental resection of the colon (e.g. sigmoid resection) for diverticulitis will be permitted. * Current anal fissure * Clinically significant structural abnormalities (eg, rectocele \> 4cm, large enterocele, full thickness rectal prolapse) that, in the opinion of the investigator, are likely contributing to symptoms * Current or past history of colon or rectal cancer, scleroderma, inflammatory bowel disease, congenital anorectal abnormalities, solitary rectal ulcer syndrome, rectal resection or pelvic irradiation * Pregnant or nursing women, prisoners and institutionalized individuals * BMI \>35 kg/m2 * Use of opioid analgesics or GLP-1 receptor agonists. Patients on opioids will be allowed to participate if they have discontinued them for at least 1 week before the date of screening and are willing to stay off them for the duration of the study. * Current use of anticholinergics (eg. amitriptyline, hyoscyamine). Patients who use low dose tricyclic antidepressants (nortriptyline or amitriptyline up to 50 mg/day) will be eligible provided they do not increase the dose during the study period. Patients on higher doses are eligible to participate if it is safe and they are willing to reduce their medication dose at least 3 days (72 hrs) before the date of screening and are willing to stay off them till the study is complete. * Current use of laxatives (Ex-lax, senna, herbal supplements), linaclotide, lubiprostone, and prucalopride to treat constipation- patients using these medications will be eligible to participate if they can discontinue the medication at least 3 days (72 hrs.) before the date of screening and are willing to stay off them till the study is complete (As detailed later, all participants can use Miralax throughout the study). * Any other factors that increase the risk to participants of participating in the study and/or undermine the integrity of the data.
Where this trial is running
Rochester, Minnesota
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Adil E. Bharucha, MBBS, MD — Mayo Clinic
- Study coordinator: Kelly J. Feuerhak, RN, CCRP
- Email: feuerhak.kelly@mayo.edu
- Phone: 507-255-6802
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.