Constipation Aggravated, Pelvic Floor; Incompetency
Conditions
Brief summary
Supporting the pelvic floor can reduce symptoms of constipation in patients with refractory constipation due to pelvic floor laxity and excessive perineal descent by means of a modified toilet seat, known as the Bottom's Up.
Detailed description
Efficacy and safety of a unique pelvic floor support device that fits into the Radiology defecography commode will be tested. Patients with refractory constipation due to known pelvic floor laxity and/or excessive perineal descent will be examined without, then with the device in place. Patients will complete questionnaires pertaining to device safety and efficacy before and after using the device. Radiographic images to document efficacy of support plus adequate emptying will be acquired during the study resulting in very low dose radiation exposure.
Interventions
DEVICEthe Bottom's Up
A modified toilet seat that supports the perineum, preventing excessive pelvic floor descent and laxity which can cause constipation.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
10 Males and female subjects greater that 18 years of age with aggravated constipation due to pelvic floor laxity of at least 4 cm and excessive perineal descent of at least 4 cm will be evaluated. Patients with constipation but no excessive laxity or descent will not be evaluated. Patients must be willing to sign consent, undergo defecography with and without The Bottom's Up device.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | through study completion, approximately one day | The number of participants to report adverse events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sense of Staining | post-defecography test, approximately 1 day | Sense of straining was measured using the self-reported answer to the modified Pelvic Floor Distress Inventory Questionnaire-20 (PFDI-20) question of 'Did you need to strain hard to empty your rectum'. The Likert scale questionnaire scores ranged from 0-10 where 0 = No, not at all and 10 = Yes, quite a bit. |
| Ease of Evacuation | post-defecography test, approximately 1 day | Ease of evacuation was measured using the self-reported answer to the modified Pelvic Floor Distress Inventory Questionnaire-20 (PFDI-20) question of 'Did you experience pain/discomfort when you emptied your rectum'. The Likert scale questionnaire scores ranged from 0-10 where 0 = No, not at all and 10 = Yes, quite a bit. |
| Completeness of Evacuation | post-defecography test, approximately 1 day | Completeness of evacuation was measured using the self-reported answer to the modified Pelvic Floor Distress Inventory Questionnaire-20 (PFDI-20) question of 'Did you feel that you completely emptied your rectum during this test'. The Likert scale questionnaire scores ranged from 0-10 where 0 = No, not at all and 10 = Yes, quite a bit. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Experimental Pelvic floor support device to treat refractory constipation.
the Bottom's Up: A modified toilet seat that supports the perineum, preventing excessive pelvic floor descent and laxity which can cause constipation. | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Experimental | — |
|---|---|---|
| Age, Continuous | 54 years STANDARD_DEVIATION 18.4 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 12 Participants | — |
| Sex: Female, Male Female | 12 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
Adverse Events
The number of participants to report adverse events.
Time frame: through study completion, approximately one day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Experimental | Adverse Events | 0 Participants |
Secondary
Completeness of Evacuation
Completeness of evacuation was measured using the self-reported answer to the modified Pelvic Floor Distress Inventory Questionnaire-20 (PFDI-20) question of 'Did you feel that you completely emptied your rectum during this test'. The Likert scale questionnaire scores ranged from 0-10 where 0 = No, not at all and 10 = Yes, quite a bit.
Time frame: post-defecography test, approximately 1 day
Population: Two subjects did not complete the questionnaire
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental | Completeness of Evacuation | 5.3 score on a scale | Standard Deviation 3 |
Secondary
Ease of Evacuation
Ease of evacuation was measured using the self-reported answer to the modified Pelvic Floor Distress Inventory Questionnaire-20 (PFDI-20) question of 'Did you experience pain/discomfort when you emptied your rectum'. The Likert scale questionnaire scores ranged from 0-10 where 0 = No, not at all and 10 = Yes, quite a bit.
Time frame: post-defecography test, approximately 1 day
Population: Two subjects did not complete the questionnaire
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental | Ease of Evacuation | 2.9 score on a scale | Standard Deviation 3.4 |
Secondary
Sense of Staining
Sense of straining was measured using the self-reported answer to the modified Pelvic Floor Distress Inventory Questionnaire-20 (PFDI-20) question of 'Did you need to strain hard to empty your rectum'. The Likert scale questionnaire scores ranged from 0-10 where 0 = No, not at all and 10 = Yes, quite a bit.
Time frame: post-defecography test, approximately 1 day
Population: Two subjects did not complete the questionnaire
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental | Sense of Staining | 6.1 score on a scale | Standard Deviation 2.8 |