Management of Dyssynergic Defecation

Overview

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

Interventions

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

Primary outcome measures

• 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]

Secondary outcome measures (12)

• Change in Patient Assessment of Constipation-Symptoms (PAC-SYM) questionnaire [Time frame: 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 [Time frame: Baseline, through study completion, an average of 16 weeks, 3 months post completion , 12 months post completion]
• Physical Activity Rating Scale [Time frame: Baseline]
• Quebec User Evaluation of Satisfaction with Assistive Technology questionnaire [Time frame: through study completion, an average of 16 weeks]
• Change in stool frequency [Time frame: Baseline, through study completion, an average of 16 weeks, 3 months post completion, 12 months post completion]
• Change in stool consistency [Time frame: Baseline, through study completion, an average of 16 weeks, 3 months post completion, 12 months post completion]
• Change in anal digitation [Time frame: Baseline, through study completion, an average of 16 weeks, 3 months post completion, 12 months post completion]
• Change in sense of incomplete evacuation [Time frame: Baseline, through study completion, an average of 16 weeks, 3 months post completion, 12 months post completion]
• Change in spontaneous bowel movements [Time frame: Baseline, through study completion, an average of 16 weeks, 3 months post completion, 12 months post completion]
• Change in pain during bowel movements [Time frame: Baseline, through study completion, an average of 16 weeks, 3 months post completion, 12 months post completion]
• Change in bowel symptoms before and after biofeedback therapy [Time frame: Baseline, through study completion, an average of 16 weeks, 3 months post completion, 12 months post completion]
• Change in Hospital Anxiety and Depression (HAD) score [Time frame: Baseline, through study completion, an average of 16 weeks]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Mayo Clinic — Rochester

Identifiers

NCT: NCT07225803 · 25-003767

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗