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This study will compare voiding assessment based on a minimum spontaneous voided volume of 150 cc with the standard retrograde fill approach in women after pelvic floor procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spontaneous void | Experimental | Subjects will not have retrograde fill of bladder, rather will be required to void 150 mL spontaneously prior to discharge. |
|
| Retrograde bladder fill | Active Comparator | Subjects will have their bladder retrograde filled with 300mL of fluid prior to a voiding trial. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Retrograde bladder fill | Procedure | Subjects will have their bladder retrograde filled with 300mL of fluid prior to a voiding trial. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Failure rate | The percentage of subjects who did not meet the required voiding assessment criteria and needed catheterization . | Up to 2 days post op |
| Measure | Description | Time Frame |
|---|---|---|
| False pass rate | The percentage of women who initially met the voiding assessment but returned for re-catheterization due to voiding difficulty . | up to 30 days after discharge. |
| Force of stream (FOS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Harmanli Oz, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | New Haven | Connecticut | 06510 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34184246 | Derived | Ellahi A, Stewart F, Kidd EA, Griffiths R, Fernandez R, Omar MI. Strategies for the removal of short-term indwelling urethral catheters in adults. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD004011. doi: 10.1002/14651858.CD004011.pub4. |
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| spontaneous void | Other | Subjects will not have retrograde fill of bladder, rather will be required to void 150 mL spontaneously prior to discharge. |
|
Patient reported force of stream (FOS) during voiding; (0 being no urination, 10 being normal strong flow).
| Up to 2 days post op. |
| Force of stream (FOS) | Patient reported force of stream (FOS) during voiding; (0 being no urination, 10 being normal strong flow). | Up to 2 days post-surgery. |
| Patient Satisfaction Questionnaire for Voiding Assessment-method used | This question asks "How satisfied were you with the method we used to evaluate how well you could urinate after our surgery?" It is measured on a continuum from 0 (very dissatisfied) to 100 (very satisfied). | Up to 2 days post-surgery. |
| Patient Satisfaction Questionnaire for Voiding Assessment-negative emotions | This question asks "Did you experience any negative emotions such as fear or anxiety when we were evaluating urination after our surgery?" It is measured on a continuum from 0 (many negative emotions) to 100 (no negative emotions). | Up to 2 days post-surgery. |
| Patient Satisfaction Questionnaire for Voiding Assessment-recommend method | This question asks "How likely would you be to recommend to a friend or family member, the method we used to evaluate your urination after our surgery, if they were in the same situation?" It is measured on a continuum from 0 (very unlikely) to 100 (very likely). | Up to 2 days post-surgery. |
| Patient Satisfaction Questionnaire for Voiding Assessment-convenience of method | This question asks "How convenient was the method we used to evaluate your urination after our surgery (e.g. time, ease etc.)? It is measured on a continuum from 0 (very inconvenient) to 100 (very convenient). | Up to 2 days post-surgery. |
| Patient Satisfaction Questionnaire for Voiding Assessment-preferred method | This question asks the patient: "If it was all up to you, which It is measured on a continuum from 0 (strongly prefer backfill before catheter) to 100 (strongly prefer no backfill before catheter removal). | Up to 2 days post-surgery. |
| Postoperative pain score | This outcome is measured by a 10-point visual analog scale where 0= no pain, 10=worst pain you have ever experienced. | One day post-surgery. |
| Urinary tract infection (UTI) | UTI is defined as culture-proven bladder infection or, in the absence of a culture, clinical suspicion of a bladder infection that resulted in treatment. | Up to 30 days post surgery. |
| Post-operative complications | Post-operative complications assessed by medical record review. | Up to 30 days post-surgery. |
| Length of hospital stay | Length of hospital stay assessed by medical record review. | Up to 2 days post-surgery. |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
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