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Urinary Catheter Self-Discontinuation After Urogynecology Surgery

NCT ID: NCT05860634

Last Updated: 2024-12-11

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

RECRUITING

Clinical Phase

NA

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2025-11-01

Brief Summary

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The goal of this randomized clinical trial is to determine if removal of transurethral urinary catheters by patients at home is as safe as catheter removal in the office following urogynecologic surgery.

Participants will be randomized to either standard catheter removal in the office or catheter self-removal at home.

Detailed Description

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This is a prospective, randomized, two-parallel arm, non-inferiority trial to evaluate two methods of catheter discontinuation in women with post-operative urinary retention (POUR) after surgery for pelvic organ prolapse (POP) or stress urinary incontinence (SUI). This study will evaluate whether self-discontinuation of transurethral catheter by patients is non-inferior to standard office discontinuation based on rates of persistent POUR on post-operative day (POD) 1.

Conditions

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Urinary Retention Pelvic Organ Prolapse Stress Urinary Incontinence Catheter Related Complication

Keywords

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Post-operative urinary retention Pelvic organ prolapse Stress urinary incontinence Cather self-discontinuation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Catheter office-discontinuation group

The patients randomized to the office-discontinuation group will visit the office for a repeat voiding trial on postoperative day 1. At this visit, the patients will undergo a backfill voiding trial.

Group Type NO_INTERVENTION

No interventions assigned to this group

Catheter self-discontinuation group

The patients randomized to the catheter self-discontinuation group will be provided with a diagrammatic handout and will be instructed to remove their indwelling urinary catheter at home on the morning of Postoperative day 1.

Group Type EXPERIMENTAL

Catheter self-discontinuation

Intervention Type PROCEDURE

Self-discontinuation of a transurethral catheter

Interventions

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Catheter self-discontinuation

Self-discontinuation of a transurethral catheter

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Are at least 18 years of age
2. Are fluent and able to read in English or Spanish
3. Undergo POP and/or SUI surgery (uterosacral ligament suspension, sacrospinous ligament fixation, sacral colpopexy, anterior colporrhaphy, posterior colporrhaphy, and/or mid-urethral sling) that occurs on Monday - Thursday
4. Have transurethral catheter in place at the conclusion of surgery as part of standard care
5. Are diagnosed with POUR on POD0 based on ultrasound bladder scan PVR of 100 mL or more
6. Are discharged home on the same day of surgery (POD 0)

Exclusion Criteria

1. Have preoperative voiding dysfunction requiring self-catheterization or indwelling transurethral catheter
2. Have physical or mental impairment that would impact their ability to remove their catheter themselves.
3. Undergo urethral bulking injections as part of surgery
4. Have undergone a planned or unplanned urinary tract procedure requiring prolonged catheterization as standard of care (e.g. cystotomy repair, ureteral reimplantation, vesicovaginal fistula repair, urethral diverticulum repair)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Texas at Austin

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mary M Rieger, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas at Austin

Collin M McKenzie, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas at Austin

Locations

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University of Texas of Austin - Dell Seton Medical Center

Austin, Texas, United States

Site Status RECRUITING

Seton Medical Center Austin

Austin, Texas, United States

Site Status RECRUITING

Ascension Seton Hays Hospital

Kyle, Texas, United States

Site Status RECRUITING

Seton Medical Center Williamson

Round Rock, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Mary M Rieger, MD

Role: CONTACT

Phone: 512-324-8670

Email: [email protected]

Facility Contacts

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Collin M McKenzie, MD

Role: primary

Collin M McKenzie, MD

Role: primary

Collin M McKenzie, MD

Role: primary

Collin M McKenzie, MD

Role: primary

Other Identifiers

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STUDY00004321

Identifier Type: -

Identifier Source: org_study_id