Recruiting

Biofeedback Treatments

Sponsor:

Mayo Clinic

Code:

NCT07225803

Conditions

Dyssynergic Defecation

Constipation

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Biofeedback

Inspiratory muscle training (IMT)

Study Details

Brief summary:

The purpose of this research is to better understand constipation and improve biofeedback treatments.

Conditions

Dyssynergic Defecation

Constipation

Study ID

NCT07225803

Start date

Jul 18, 2025

Status verified date

Oct, 2025

Completion date

Jul, 2029

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Biofeedback

During 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)

Subjects will engage in inspiratory muscle training (IMT) that is tailored to the baseline performance of the individual.

Primary outcome measure

  • Change in rectoanal gradient during evacuation [ Time Frame: Baseline, through study completion, an average of 16 weeks ]
  • Change in rectal pressure during evacuation [ Time Frame: Baseline, through study completion, an average of 16 weeks ]
  • Change in balloon expulsion time [ Time Frame: Baseline, through study completion, an average of 16 weeks ]
  • Change in rectal emptying time [ Time Frame: Baseline, through study completion, an average of 16 weeks ]
  • Change in rectal emptying rate [ Time Frame: Baseline, through study completion, an average of 16 weeks ]

Central Contacts and Locations

Central contacts

Kelly J. Feuerhak, RN, CCRP

507-255-6802feuerhak.kelly@mayo.edu

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Kelly J. Feuerhak, RN, CCRP

507-255-6802feuerhak.kelly@mayo.edu

More Information

Sponsor

Mayo Clinic

Last update posted

Nov 10, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2025-11-10.