RECRUITING

Urinary Catheter Self-Discontinuation After Urogynecology Surgery

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Conditions

Urinary RetentionPelvic Organ ProlapseStress Urinary IncontinenceCatheter Related ComplicationPost-operative urinary retentionCather self-discontinuation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Urinary Catheter Self-Discontinuation After Urogynecology Surgery

Quick Facts

Study Start:2023-08-01
Study Completion:2024-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05860634

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Are at least 18 years of age
  2. 2. Are fluent and able to read in English or Spanish
  3. 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. 4. Have transurethral catheter in place at the conclusion of surgery as part of standard care
  5. 5. Are diagnosed with POUR on POD0 based on ultrasound bladder scan PVR of 100 mL or more
  6. 6. Are discharged home on the same day of surgery (POD 0)
  1. 1. Have preoperative voiding dysfunction requiring self-catheterization or indwelling transurethral catheter
  2. 2. Have physical or mental impairment that would impact their ability to remove their catheter themselves.
  3. 3. Undergo urethral bulking injections as part of surgery
  4. 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)

Contacts and Locations

Study Contact

Mary M Rieger, MD
CONTACT
512-324-8670
mary.rieger@austin.utexas.edu

Principal Investigator

Mary M Rieger, MD
PRINCIPAL_INVESTIGATOR
University of Texas at Austin
Collin M McKenzie, MD
PRINCIPAL_INVESTIGATOR
University of Texas at Austin

Study Locations (Sites)

University of Texas of Austin - Dell Seton Medical Center
Austin, Texas, 78701
United States
Seton Medical Center Austin
Austin, Texas, 78705
United States
Ascension Seton Hays Hospital
Kyle, Texas, 78640
United States
Seton Medical Center Williamson
Round Rock, Texas, 78665
United States

Collaborators and Investigators

Sponsor: University of Texas at Austin

  • Mary M Rieger, MD, PRINCIPAL_INVESTIGATOR, University of Texas at Austin
  • Collin M McKenzie, MD, PRINCIPAL_INVESTIGATOR, University of Texas at Austin

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-01
Study Completion Date2024-10

Study Record Updates

Study Start Date2023-08-01
Study Completion Date2024-10

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Urinary Retention
  • Pelvic Organ Prolapse
  • Stress Urinary Incontinence
  • Catheter Related Complication