Pelvic Organ Prolapse, Urinary Incontinence
Conditions
Brief summary
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.
Interventions
PROCEDURERetrograde bladder fill
Subjects will have their bladder retrograde filled with 300mL of fluid prior to a voiding trial.
OTHERspontaneous void
Subjects will not have retrograde fill of bladder, rather will be required to void 150 mL spontaneously prior to discharge.
Sponsors
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All 18-year-old or older women who undergo surgery for urinary incontinence and/or pelvic organ prolapse (POP)
Exclusion criteria
* Patients who require prolonged Foley catheter or suprapubic catheter
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Failure rate | Up to 2 days post op | The percentage of subjects who did not meet the required voiding assessment criteria and needed catheterization . |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Force of stream (FOS) | Up to 2 days post op. | Patient reported force of stream (FOS) during voiding; (0 being no urination, 10 being normal strong flow). |
| Patient Satisfaction Questionnaire for Voiding Assessment-method used | Up to 2 days post-surgery. | 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). |
| Patient Satisfaction Questionnaire for Voiding Assessment-negative emotions | Up to 2 days post-surgery. | 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). |
| Patient Satisfaction Questionnaire for Voiding Assessment-recommend method | Up to 2 days post-surgery. | 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). |
| Patient Satisfaction Questionnaire for Voiding Assessment-convenience of method | Up to 2 days post-surgery. | 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). |
| False pass rate | up to 30 days after discharge. | The percentage of women who initially met the voiding assessment but returned for re-catheterization due to voiding difficulty . |
| Postoperative pain score | One day post-surgery. | This outcome is measured by a 10-point visual analog scale where 0= no pain, 10=worst pain you have ever experienced. |
| Urinary tract infection (UTI) | Up to 30 days post surgery. | 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. |
| Post-operative complications | Up to 30 days post-surgery. | Post-operative complications assessed by medical record review. |
| Length of hospital stay | Up to 2 days post-surgery. | Length of hospital stay assessed by medical record review. |
| Patient Satisfaction Questionnaire for Voiding Assessment-preferred method | Up to 2 days post-surgery. | 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). |
Countries
United States
Outcome results
None listed