Constipation
Conditions
Brief summary
Constipation is a very common problem. Western style toilets that are nearly universal in the United States require the person to sit on the toilet. However, results from uncontrolled studies suggests that a squatting posture (as prevalent in many foreign countries) may be better at facilitating evacuation compared to a Western style commode. One uncontrolled, unpublished study suggests that a footstool improved bowel symptoms in nearly 98% of 153 constipated participants. Hence, the investigators propose to evaluate the benefits of a footstool on symptoms and anorectal functions in constipated patients. Hypothesis: the regular squatting assist device (7 inches) but not a sham device (2 inches tall) will improve symptoms of constipation.
Interventions
DEVICESquatting Assist Device
The Squatty Potty is a 7 inch tall stool to assist subjects in maintaining a squatting position while using a toilet. While sitting on the toilet, the subject supports her feet on the Squatty Potty.
DEVICESham Squatting Assist Device
This stool will be 2 inches tall and be similar in appearance to the Squatty Potty. While sitting on the toilet, the subject supports her feet on the 2 inch high stool.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Able to communicate adequately with the investigator and to comply with the requirements for the entire study * Meet Rome III criteria for functional constipation as assessed by questionnaires in period 1, i.e., report at least 2 of the following symptoms for last 3 months or more with symptom onset at least 6 months prior to diagnosis: a) \<3 SBMs/week b) hard or lumpy stools ≥ 25% of time c) straining ≥ 25% of time d) sense of incomplete evacuation ≥ 25% of time e) feeling of anorectal blockage ≥ 25% of time or f) manual maneuvers to facilitate defecation ≥ 25% of time. Patients who meet Rome III criteria for irritable bowel syndrome will also be eligible provided they also meet above criteria.
Exclusion criteria
* Clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal. hematological, neurological, psychiatric or other disease 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 or past history of colon or rectal cancer, scleroderma, inflammatory bowel disease, congenital anorectal abnormalities, rectal prolapse, solitary rectal ulcer syndrome, history of rectal resection or pelvic irradiation * Active cancer * Pregnant or nursing women, prisoners and institutionalized individuals * Weight \> 300 lbs. * Current or Prior use of Squatty Potty® * Current use of opioid analgesics. Patients on opioids will be allowed to participate if they have discontinued them for at least 3 days (72 hrs.) before date of screening and are willing to stay off them for the duration of the study. * Current use of anticholinergics (e.g. nortriptyline, amitriptyline, hyoscyamine). Patients who use low dose tricyclic antidepressants (nortriptyline upto 50 mg/day or amitriptyline upto 25 mg/day ) will be eligible provided they do not increase the dose during the study period. Patients on higher doses or on other anticholinergics are eligible to participate if they can discontinue their medication 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 (MiraLax, 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Weekly Complete Spontaneous Bowel Movement (CSBM) Frequency | baseline, 4 weeks | Subjects completed a bowel diary indicating the number of CSBMs they had each week. Weekly CSBM Frequency = (Number of CSBMs recorded in 7 days/Number of days with bowel entries in subject diary) X 7 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Weekly Spontaneous Bowel Movement (SBM) Frequency | Baseline; 4 weeks | Subjects completed a bowel diary indicating the number of SBMs (bowel movements that occurred without requiring the use of a laxative or enema or of manual disimpaction) they had each week. Weekly SBM frequency= (Number of SBMs recorded in 7 days /Number of days with bowel entries) X 7 |
| Mean Bristol Stool Form Score (BSFS) | Baseline; 4 weeks | The Bristol Stool Scale classifies human stool into seven types, ranging from hard lumps (1) indicating constipation to watery stools (7) indicating diarrhea. Total scores range from 1 to 7 with higher scores indicating less constipation. |
| Straining Severity Score | Baseline; 4 weeks | Straining severity score was measured using a 5-point scale. Total scores ranged from 1 to 5 with higher scores indicating more severe straining. |
| Worst Abdominal Bloating Score | Baseline; 4 Weeks | Worse abdominal bloating score was measured using a 5-point scale. Total scores ranged from 1 to 5 with higher scores indicating more abdominal bloating. |
| Average Overall Relief of Constipation Score | Week 2, Week 3, Week 4 | Overall relief of constipation score was measured using a 7-point scale. Scores ranged from 1 (considerably relieved) to 7 (significantly worse) with higher scores indicating worse overall relief. The average scores were calculated through week 2, week 3 and week 4 then combined for a total overall average relief score divided by 3. |
| Adequate Relief of Constipation | Week 1, Week 2, Week 3, Week 4 | The number of subjects who reported adequate relief of constipation for ≥ 3 of 4 weeks during treatment period |
| Satisfaction With Effects of the Foot Stool on Bowel Symptoms | 4 Weeks | Satisfaction was rated on a 5-point scale from 1 (not at all satisfied) to 5 (very satisfied). Total score ranges from 1-5 with higher scores indicating higher satisfaction. |
| Perceived Improvement in Constipation With Foot Stool Use | 4 Weeks | Perceived improvement in constipation with foot stool use was measured using a 100-point scale. Scores ranged from 0 (no improvement) to 100 (extremely improved) with higher scores indicating higher perceived improvement. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAdil E Bharucha, MBBS, MD
Mayo Clinic
Participant flow
Pre-assignment details
107 subjects were enrolled however 43 subjects were excluded prior to randomization due to 25 subjects screen failing and 18 subjects withdrawing.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 50.3 years STANDARD_DEVIATION 12 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 61 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 59 Participants |
| Region of Enrollment United States | 64 participants |
| Sex: Female, Male Female | 64 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 33 |
| other Total, other adverse events | 0 / 31 | 0 / 33 |
| serious Total, serious adverse events | 0 / 31 | 0 / 33 |
Outcome results
None listed