Treatment of Postpartum Urinary Retention

Study Overview
=================
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
-----------------
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.

Official Title
-----------------
Intermittent Versus Continous Catheterization for Treatment of Postpartum Urinary Retention.

Conditions
-----------------
Retention, Urinary

Intervention / Treatment
-----------------
* Device: Foley Catheter


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intermittent catheterization<br>women who are catheterized intermittently every 6-8 hours up to a total time of 48 hours | Device: Foley Catheter<br>* Foley catheter used for treatment of urinary retention<br>|
| Active Comparator: Continous catheterization<br>women which will have an indwelling catheter inserted for 24 hours | Device: Foley Catheter<br>* Foley catheter used for treatment of urinary retention<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean time for urinary retention resolution. | Mean time for urinary retention resolution following the intervention. | Up to 10 days from diagnosis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary tract infection rate | Incidence of Urinary tract infections | Up to 96 hours from diagnosis | 
| Length of hospital stay | Length of hospital stay | Up to 96 hours from diagnosis |