Voiding Assessment Based on Minimum Spontaneous Void of 150 mL Compared to Retrograde Fill Method After Female Pelvic Floor Reconstructive Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Voiding Assessment Based on Minimum Spontaneous Void of 150 mL Compared to Retrograde Fill Method After Female Pelvic Floor Reconstructive Surgery: A Randomized Controlled Trial

Conditions
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Urinary Incontinence, Pelvic Organ Prolapse

Intervention / Treatment
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* Procedure: Retrograde bladder fill
* Other: spontaneous void


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spontaneous void<br>Subjects will not have retrograde fill of bladder, rather will be required to void 150 mL spontaneously prior to discharge. | Other: spontaneous void<br>* Subjects will not have retrograde fill of bladder, rather will be required to void 150 mL spontaneously prior to discharge.<br>|
| Active Comparator: Retrograde bladder fill<br>Subjects will have their bladder retrograde filled with 300mL of fluid prior to a voiding trial. | Procedure: Retrograde bladder fill<br>* Subjects will have their bladder retrograde filled with 300mL of fluid prior to a voiding trial.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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. |