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

NCT ID: NCT03539107

Last Updated: 2020-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2019-12-20

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.

Detailed Description

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Conditions

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Urinary Incontinence Pelvic Organ Prolapse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Spontaneous void

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

Group Type EXPERIMENTAL

spontaneous void

Intervention Type OTHER

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

Retrograde bladder fill

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

Group Type ACTIVE_COMPARATOR

Retrograde bladder fill

Intervention Type PROCEDURE

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

Interventions

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Retrograde bladder fill

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

Intervention Type PROCEDURE

spontaneous void

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

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Harmanli Oz, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Yale University

New Haven, Connecticut, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 34184246 (View on PubMed)

Other Identifiers

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Popiel02

Identifier Type: -

Identifier Source: org_study_id

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