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CompletedNCT04104165Updated Aug 16, 2022

Treatment of Postpartum Urinary Retention

An interventional study of Foley Catheter in Retention, Urinary, sponsored by Rambam Health Care Campus. Completed at 1 site in Israel. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2022-08-16.

Sponsored by Rambam Health Care Campus · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
146
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study 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.

Read the detailed description
  1. Women who are unable to micturate for more than 6-8 hours following vaginal delivery or within six to eight hours following removal of an indwelling catheter after cesarean delivery (overt postpartum urinary retention), or women with postvoid residual bladder volume of at least 150 mL (covert postpartum urinary retention) will be randomized into 2 groups: one group will include women who are catheterized intermittently every 6-8 hours up to a total time of 48 hours. If at any time, post voiding residual volume is less than 150cc (assessed by ultrasound or by catheterization), no additional catheterization is needed. The second group will include women which will have an indwelling catheter inserted for 24 hours. The catheter will be removed 24 hours following its insertion and post voiding residual volume will be assessed 6 hours following the catheter removal (by ultrasound or by catheterization). In cases of post voiding residual volume more than 150 cc or women are unable to micturate spontaneously, an indwelling catheter will be inserted for additional 24 hours.
  2. After 48 hours from postpartum urinary retention diagnosis, an indwelling catheter will be inserted for additional time that will be set at every center by its common protocol.
02

Conditions studied

  • Retention, Urinary

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03

In context

Urinary Retention

235 studies on the registry are indexed under Urinary Retention; 39 are open to participants now.

This study's enrollment of 146 is above the median of 95 across 185 interventional studies indexed under Urinary Retention.

Browse Urinary Retention studies →

Lead sponsor

Rambam Health Care Campus is the lead sponsor of 456 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Spontaneous micturition 6-8 hours following vaginal or cesarean delivery
  • postpartum urinary retention less than 150cc on ultrasound
  • Known urinary tract infection
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
146 participants (actual)

Study arms

  • Active comparator
    Intermittent catheterization

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

    Device: Foley Catheter

  • Active comparator
    Continous catheterization

    women which will have an indwelling catheter inserted for 24 hours

    Device: Foley Catheter

Interventions

  • DeviceFoley Catheter

    Foley catheter used for treatment of urinary retention

06

What researchers measure

Primary outcomes

  1. Mean time for urinary retention resolution.

    Mean time for urinary retention resolution following the intervention.

    Time frame: Up to 10 days from diagnosis

Secondary outcomes

  1. Urinary tract infection rate

    Incidence of Urinary tract infections

    Time frame: Up to 96 hours from diagnosis

  2. Length of hospital stay

    Length of hospital stay

    Time frame: Up to 96 hours from diagnosis

07

Study locations

1 site
  • Rambam Healthcare Campus
    Haifa, Israel
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 16, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04104165
Lead sponsor
Rambam Health Care Campus
Responsible party
ROY LAUTERBACH MD (Principal investigator, Rambam Health Care Campus) — Principal investigator
First posted
Sep 26, 2019
Start date
Jan 1, 2020
Primary completion
Apr 30, 2022
Completion
May 31, 2022
Last update
Aug 16, 2022

Study contacts

Roy Lauterbach, MD
principal investigator · Rambam Healthcare Campus

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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