Management of Dyssynergic Defecation

NCT07225803 | Recruiting

• 1 other identifier: 25-003767
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dyssynergic Defecation; Constipation

Outcome Measures

Primary Outcomes (5)

• Change in rectoanal gradient during evacuation

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

  Baseline, through study completion, an average of 16 weeks

• Change in rectal pressure during evacuation

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

  Baseline, through study completion, an average of 16 weeks

• Change in balloon expulsion time

  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.

  Baseline, through study completion, an average of 16 weeks

• Change in rectal emptying time

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

  Baseline, through study completion, an average of 16 weeks

• Change in rectal emptying rate

  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).

  Baseline, through study completion, an average of 16 weeks

Secondary Outcomes (23)

• Change in Patient Assessment of Constipation-Symptoms (PAC-SYM) questionnaire

  Baseline, through study completion, an average of 16 weeks, 3 months post completion, 12 months post completion

• Change in Patient Assessment of Constipation - Quality of Life (PAC-QOL) questionnaire

  Baseline, through study completion, an average of 16 weeks, 3 months post completion , 12 months post completion

• Physical Activity Rating Scale

  Baseline

• Quebec User Evaluation of Satisfaction with Assistive Technology questionnaire

  through study completion, an average of 16 weeks

• Change in stool frequency

  Baseline, through study completion, an average of 16 weeks, 3 months post completion, 12 months post completion

Study Arms (2)

Biofeedback and inspiratory muscle training (BFT Plus)

EXPERIMENTAL

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.

Behavioral: Biofeedback; Behavioral: Inspiratory muscle training (IMT)

Biofeedback only (BFT Alone)

ACTIVE COMPARATOR

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.

Behavioral: Biofeedback

Interventions

Biofeedback BEHAVIORAL

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.

Biofeedback and inspiratory muscle training (BFT Plus); Biofeedback only (BFT Alone)

Inspiratory muscle training (IMT) BEHAVIORAL

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

Biofeedback and inspiratory muscle training (BFT Plus)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Constipation

Interventions

Biofeedback, Psychology

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Officials

• Adil E. Bharucha, MBBS, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kelly J. Feuerhak, RN, CCRP

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 17, 2025
• First Posted: November 10, 2025
• Study Start: July 18, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2029
• Last Updated: November 10, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)