NCT04104165

Brief Summary

The aim of the study is to evaluate what is the most effective catheterization duration to resolve covert and overt postpartum urinary retention following vaginal delivery and caesarean delivery, with the highest patients' satisfaction.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 26, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
Last Updated

August 16, 2022

Status Verified

August 1, 2022

Enrollment Period

2.3 years

First QC Date

September 24, 2019

Last Update Submit

August 12, 2022

Conditions

Retention, Urinary

Outcome Measures

Primary Outcomes (1)

  • Mean time for urinary retention resolution.

    Mean time for urinary retention resolution following the intervention.

    Up to 10 days from diagnosis

Secondary Outcomes (2)

  • Urinary tract infection rate

    Up to 96 hours from diagnosis

  • Length of hospital stay

    Up to 96 hours from diagnosis

Study Arms (2)

Intermittent catheterization

ACTIVE COMPARATOR

women who are catheterized intermittently every 6-8 hours up to a total time of 48 hours

Device: Foley Catheter

Continous catheterization

ACTIVE COMPARATOR

women which will have an indwelling catheter inserted for 24 hours

Device: Foley Catheter

Interventions

Foley CatheterDEVICE

Foley catheter used for treatment of urinary retention

Continous catheterizationIntermittent catheterization

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale patients
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women who deliver at one of the centers included in the study
  • Overt postpartum urinary retention which refers to the absence of spontaneous micturition within six to eight hours of vaginal delivery; or within six to eight hours following removal of an indwelling catheter after cesarean delivery
  • Covert postpartum urinary retention diagnosed by ultrasound or catheterization of more than 150cc

You may not qualify if:

  • Spontaneous micturition 6-8 hours following vaginal or cesarean delivery
  • postpartum urinary retention less than 150cc on ultrasound
  • Known urinary tract infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Healthcare Campus

Haifa, Israel

Location

MeSH Terms

Conditions

Urinary Retention

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Roy Lauterbach, MD

    Rambam Healthcare Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 24, 2019

First Posted

September 26, 2019

Study Start

January 1, 2020

Primary Completion

April 30, 2022

Study Completion

May 31, 2022

Last Updated

August 16, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)