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NCT02996968

Self-discontinuation of a Transurethral Catheter

Completed NA Results posted Last updated 12 November 2019
What this trial tests

NA trial testing Self-removal in Postoperative Urinary Retention in 158 participants. Completed in 16 May 2019.

Timeline
10 January 2017
Primary endpoint
16 May 2019
16 May 2019

Quick facts

Lead sponsorTriHealth Inc.
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposesupportive care
Enrollment158
Start date10 January 2017
Primary completion16 May 2019
Estimated completion16 May 2019
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

TriHealth Inc. — full company profile →

Who can join

18 and older, female only, with Postoperative Urinary Retention. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Postoperative Urinary Retention Primary · postoperative day 6-8

Number of Participants with postoperative urinary retention (POUR) following pelvic reconstructive surgery for pelvic organ prolapse. Pour at 1-week was defined as continued catheterization on POD 6-8

GroupValue95% CI
Self-discontinuation Group11
Office-discontinuation Group11

Sponsor's own description

This study is to determine if self-discontinuation of transurethral foley catheters in patients diagnosed with postoperative urinary retention (POUR), which is defined as the continued need for catheterization, following impatient pelvic organ prolapse surgery is non-inferior to office-discontinuation.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Self-Removal of a Urinary Catheter After Urogynecologic Surgery: A Randomized Controlled Trial.
    Shatkin-Margolis A, Yook E, Hill AM, Crisp CC, et al · · 2019 · cited 23× · PMID 31599827 · DOI 10.1097/aog.0000000000003531
  2. Strategies for the removal of short-term indwelling urethral catheters in adults.
    Ellahi A, Stewart F, Kidd EA, Griffiths R, et al · · 2021 · cited 18× · PMID 34184246 · DOI 10.1002/14651858.cd004011.pub4

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Other TriHealth Inc. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02996968.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing