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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".
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Pelvic floor support device to treat refractory constipation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| "the Bottom's Up" | Device | A modified toilet seat that supports the perineum, preventing excessive pelvic floor descent and laxity which can cause constipation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | The number of participants to report adverse events. | through study completion, approximately one day |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | post-defecography test, approximately 1 day |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Amy Foxx-Orenstein, DO | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Arizona | Scottsdale | Arizona | 85259 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Adverse Events | The number of participants to report adverse events. | Posted | Count of Participants | Participants | through study completion, approximately one day |
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Adverse event data were collected for the duration each subject was enrolled in the study, one day.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Amy Foxx-Orenstein | Mayo Clinic | 480-301-6990 | foxx-orenstein.amy@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 1, 2016 | Aug 11, 2020 | Prot_SAP_000.pdf |
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| 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. | post-defecography test, approximately 1 day |
| 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. | post-defecography test, approximately 1 day |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 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. | Two subjects did not complete the questionnaire | Posted | Mean | Standard Deviation | score on a scale | post-defecography test, approximately 1 day |
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| 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. | Two subjects did not complete the questionnaire | Posted | Mean | Standard Deviation | score on a scale | post-defecography test, approximately 1 day |
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| 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. | Two subjects did not complete the questionnaire | Posted | Mean | Standard Deviation | score on a scale | post-defecography test, approximately 1 day |
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| 0 |
| 12 |
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| 12 |
| 0 |
| 12 |
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