Clinical trial NCT04104165: Treatment of Postpartum Urinary Retention
Official title: Intermittent Versus Continous Catheterization for Treatment of Postpartum Urinary Retention.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retention, Urinary
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2019-09-26
Enrollment: 146
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Mean time for urinary retention resolution.
timeFrame: Up to 10 days from diagnosis
Secondary outcomes:
measure: Urinary tract infection rate
timeFrame: Up to 96 hours from diagnosis
measure: Length of hospital stay
timeFrame: Up to 96 hours from diagnosis
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Healthcare Campus
Study officials:
affiliation: Rambam Healthcare Campus
name: Roy Lauterbach, MD
role: PRINCIPAL_INVESTIGATOR
References: