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Study on Biofeedback and Inspiratory Muscle Training for Dyssynergic Defecation

This study is looking for people aged 18-80 with dyssynergic defecation (a type of constipation where muscles don't work together properly during bowel movements) to better understand and improve treatments. You would receive either biofeedback therapy, which helps you learn to control your muscles using a computer monitor, or inspiratory muscle training (IMT), which involves exercises to strengthen your breathing muscles. Researchers will measure changes in how your muscles work during bowel movements and how long it takes to expel a balloon over about 16 weeks to see if these treatments are successful. The study is currently recruiting up to 200 participants.

Study design
This interventional study plans to enroll 200 participants. It is not specified if it is randomized or blinded.
What's involved
Participants will receive either biofeedback therapy or inspiratory muscle training. Measurements will be taken at the beginning of the study and through study completion, which is an average of 16 weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed through study completion, an average of 16 weeks, to measure changes in primary endpoints.

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NCT07225803

Management of Dyssynergic Defecation

Recruiting
NAAges 18–80InterventionalTreatment
Mayo Clinic
~200 participants
Updated 2025-11-10 on ClinicalTrials.gov
What's tested:BiofeedbackInspiratory muscle training (IMT)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in rectoanal gradient during evacuation
Measured over Baseline, through study completion, an average of 16 weeks
+4 more outcomes measured

Conditions

Dyssynergic Defecation
Constipation

Explore related trials

ConstipationDyssynergic Defecation

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • Adil E. Bharucha, MBBS, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Kelly J. Feuerhak, RN, CCRP
[email protected]
507-255-6802
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Change in rectoanal gradient during evacuationBaseline, through study completion, an average of 16 weeks

    Rectoanal gradient during evacuation is the pressure difference between the rectum and the anal canal during simulated evacuation, measured in millimeters of mercury (mmHg).

  • Change in rectal pressure during evacuationBaseline, through study completion, an average of 16 weeks

    Rectal pressure during evacuation is the difference in rectal pressure during - before evacuation. Results are measured in millimeters of mercury (mmHg).

  • Change in balloon expulsion timeBaseline, through study completion, an average of 16 weeks

    Rectal balloon expulsion directly assesses evacuation. Patients will be asked to expel a rectal balloon inflated up to 50 ml of water. The time required to expel the balloon will be measured and reported in seconds.

  • Change in rectal emptying timeBaseline, through study completion, an average of 16 weeks

    Rectal emptying will be assessed via fecoflowmetry by measuring the time required to defecate (seconds) artificial stool from the rectum

  • Change in rectal emptying rateBaseline, through study completion, an average of 16 weeks

    Rectal emptying will be assessed via fecoflowmetry by measuring the amount (gm) of artificial stool from the rectum. The 2 metrics - amount and time - are integrated to measure amount (gm) evacuated per unit time (second) (gm/sec).