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

Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03539107
• Other study ID #: Popiel02
• Status: Completed
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: December 20, 2019

Study information

• Verified date: January 2020
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: December 20, 2019
• Est. primary completion date: December 20, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse
• Urinary Incontinence

Intervention

Procedure:
• Retrograde bladder fill
Subjects will have their bladder retrograde filled with 300mL of fluid prior to a voiding trial.

Other:
• spontaneous void
Subjects will not have retrograde fill of bladder, rather will be required to void 150 mL spontaneously prior to discharge.

Locations

Country	Name	City	State
United States	Yale University	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Post-operative complications	Post-operative complications assessed by medical record review.	Up to 30 days post-surgery.
Secondary	Length of hospital stay	Length of hospital stay assessed by medical record review.	Up to 2 days post-surgery.