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

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

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.

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence; Pelvic Organ Prolapse
• Intervention / Treatment: Other: spontaneous void; Procedure: Retrograde bladder fill

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: Harmanli Oz, MD, Yale University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Actual): December 20, 2019
• Study Completion (Actual): December 20, 2019

Study Registration Dates

• First Submitted: May 15, 2018
• First Submitted That Met QC Criteria: May 24, 2018
• First Posted (Actual): May 29, 2018

Study Record Updates

• Last Update Posted (Actual): January 13, 2020
• Last Update Submitted That Met QC Criteria: January 8, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Pathological Conditions, Anatomical; Urinary Incontinence; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: Popiel02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No