Treatment of Postpartum Urinary Retention

NCT ID: NCT04104165

Last Updated: 2022-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 146 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2022-05-31

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.

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.

Conditions

Retention, Urinary

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intermittent catheterization

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

Group Type: ACTIVE_COMPARATOR

Foley Catheter

Intervention Type: DEVICE

Foley catheter used for treatment of urinary retention

Continous catheterization

women which will have an indwelling catheter inserted for 24 hours

Group Type: ACTIVE_COMPARATOR

Foley Catheter

Intervention Type: DEVICE

Foley catheter used for treatment of urinary retention

Interventions

Foley Catheter

Foley catheter used for treatment of urinary retention

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Rambam Health Care Campus

OTHER

Sponsor Role: lead

Responsible Party

ROY LAUTERBACH MD

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Roy Lauterbach, MD

Role: PRINCIPAL_INVESTIGATOR

Rambam Healthcare Campus

Locations

Rambam Healthcare Campus

Haifa, , Israel

Countries

Israel

Other Identifiers

0515-19-RMB

Identifier Type: -

Identifier Source: org_study_id