Management of Dyssynergic Defecation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorMayo Clinic
About this trial
The purpose of this research is to better understand constipation and improve biofeedback treatments.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Biofeedback
BehavioralDuring 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)
BehavioralSubjects will engage in inspiratory muscle training (IMT) that is tailored to the baseline performance of the individual.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Biofeedback and inspiratory muscle training (BFT Plus)Experimental treatment 2 interventions
Group B: Biofeedback only (BFT Alone)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
Baseline, through study completion, an average of 16 weeks2
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).
Time frame
Baseline, through study completion, an average of 16 weeks3
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.
Time frame
Baseline, through study completion, an average of 16 weeks4
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
Time frame
Baseline, through study completion, an average of 16 weeksSecondary outcomes
1
Change in Patient Assessment of Constipation-Symptoms (PAC-SYM) questionnaire
The PAC-SYM questionnaire assesses the severity of patient-reported symptoms related to constipation. The questionnaire is divided into three symptom subscales: abdominal (four items); rectal (three items); and stool (five items). Items are scored on 5-point Likert scales, with scores ranging from 0 to 4 (0 = 'symptom absent', 1 = 'mild', 2 = 'moderate', 3 = 'severe' and 4 = 'very severe'). A mean total score in the range of 0-4 is generated by dividing the total score by the number of questions completed; the lower the total score, the lower the symptom burden. Scores range from 0 to 48.
Time frame
Baseline, through study completion, an average of 16 weeks, 3 months post completion, 12 months post completion2
Change in Patient Assessment of Constipation - Quality of Life (PAC-QOL) questionnaire
The PAC-QOL questionnaire is a patient-reported outcome measure to evaluate quality of life in constipated persons. The questionnaire is divided into four subscales: worries and concerns (11 items), physical discomfort (4 items), psychosocial discomfort (8 items), and satisfaction (5 items). Scale scores represent average item scores and range from 0 to 4, where higher scores represent poorer quality of life. Scores range from 0 to 112.
Time frame
Baseline, through study completion, an average of 16 weeks, 3 months post completion , 12 months post completion3
Physical Activity Rating Scale
Physical Activity Rating is a questionnaire for categorizing physical activity level, which is used in the equation for the non-exercise fitness test. The Physical Activity Rating is a score value between 0 to 7. The non-exercise fitness test of VO2max, a measure of cardiovascular fitness, will be calculated using the following equation: 56.363 + 1.921 (Physical Activity Rating) - 0.381(Age) - 0.754(Body Mass Index) + 10.987(Sex: 0 for women, 1 for men)
Time frame
Baseline4
Quebec User Evaluation of Satisfaction with Assistive Technology questionnaire
Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) 11-item questionnaire is a standardized tool to measure the satisfaction of an individual who is using an assistive device. It inquiries about the assistive device itself: dimensions, weight, ease of adjustment, safety, durability, ease of use, comfortability, and effectiveness; and service: service delivery, maintenance, professional services, and follow up services. Each question is answered on a Likert scale, where 1 = not satisfied at all, and 5 = very satisfied. Possible scores range from 11 to 55.
Time frame
through study completion, an average of 16 weeksSponsors and contacts
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Source ClinicalTrials.gov