Treatment of Postpartum Urinary Retention

Retention, Urinary Clinical Trial

Official title:

Intermittent Versus Continous Catheterization for Treatment of Postpartum Urinary Retention.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04104165
• Other study ID #: 0515-19-RMB
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: May 31, 2022

Study information

• Verified date: August 2022
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: May 31, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Retention, Urinary
• Urinary Retention

Intervention

Device:
• Foley Catheter
Foley catheter used for treatment of urinary retention

Locations

Country	Name	City	State
Israel	Rambam Healthcare Campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean time for urinary retention resolution.	Mean time for urinary retention resolution following the intervention.	Up to 10 days from diagnosis
Secondary	Urinary tract infection rate	Incidence of Urinary tract infections	Up to 96 hours from diagnosis
Secondary	Length of hospital stay	Length of hospital stay	Up to 96 hours from diagnosis