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

Yale University

Status: Completed

Conditions: Pelvic Organ Prolapse; Urinary Incontinence

Treatments: Other: spontaneous void; Procedure: Retrograde bladder fill

Study type: Interventional

Funder types: Other

Identifiers

NCT03539107

Popiel02

Details and patient eligibility

About

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.

Enrollment: 110 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

Spontaneous void

Experimental group

Description:

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

Treatment:

Other: spontaneous void

Retrograde bladder fill

Active Comparator group

Description:

Subjects will have their bladder retrograde filled with 300mL of fluid prior to a voiding trial.

Treatment:

Procedure: Retrograde bladder fill