Voiding Assessment Based on Minimum Spontaneous Void of 150 mL Compared to Retrograde Fill Method After Female Pelvic Floor Reconstructive Surgery
NCT03539107 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110
Last updated 2020-01-13
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.
Conditions
- Urinary Incontinence
- Pelvic Organ Prolapse
Interventions
- 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.
Sponsors & Collaborators
-
Yale University
lead OTHER
Principal Investigators
-
Harmanli Oz, MD · Yale University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-09-01
- Primary Completion
- 2019-12-20
- Completion
- 2019-12-20
Countries
- United States
Study Locations
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