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OpenTrials
Completed

NCT Number: NCT04104165

Treatment of Postpartum Urinary Retention

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Rambam Healthcare Campus

Haifa, Israel

About this study

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

foley catheter

Device

Foley catheter used for treatment of urinary retention

Primary outcomes

  1. Mean time for urinary retention resolution.

    Time frame: Up to 10 days from diagnosis

    Mean time for urinary retention resolution following the intervention.

Secondary outcomes

  1. Urinary tract infection rate

    Time frame: Up to 96 hours from diagnosis

    Incidence of Urinary tract infections

  2. Length of hospital stay

    Time frame: Up to 96 hours from diagnosis

    Length of hospital stay

Sponsors and collaborators

Lead sponsor

Rambam Health Care Campus

Other

Registry information

Official study title

Intermittent Versus Continous Catheterization for Treatment of Postpartum Urinary Retention.

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 26, 2019
Registry last updated
Aug 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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