Optimizing the Management of Postpartum Urinary Retention

Study Overview
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Brief Summary
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A study aimed at characterizing the comparing duration of catheterization for treatment of postpartum urinary retention (PUR) and characterizing short and long-term pelvic floor symptoms in women who have PUR.

Detailed Description
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The purpose of the study is to compare clinical outcomes of women with bladder distension injuries due to postpartum urinary retention (PUR) who have varying duration of catheterization for initial treatment of postpartum urinary retention. Hypotheses Longer duration of therapeutic catheterization will be associated with resolution of postpartum voiding dysfunction in women who sustain severe bladder distension injuries due to postpartum urinary retention. Definition of resolution of postpartum voiding dysfunction: A. A post void residual volume of less than half of initial instilled volume on the first retrograde voiding trial, AND B. No need for re-treatment for urinary retention within 1 week The incidence of postpartum urinary retention (PUR) will vary by route of delivery, with operative vaginal delivery having the highest incidence. Risk factors for PUR will be related to intrapartum and delivery conditions

Official Title
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Optimizing the Management of Postpartum Urinary Retention: Postpartum Urinary Retention (PUR) Study

Conditions
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Urinary Retention

Intervention / Treatment
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* Other: Duration of Indwelling Catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age greater than or equal to 18. Vaginal or cesarean delivery at term (37 weeks gestational age or later) of live-born infants. English or Spanish speaking and reading. Exclusion Criteria: Adults unable to consent. Women under the age of 18. Women who are currently pregnant (All women in the study will have already delivered). Prisoners or detained individuals. Women who chronically use a urinary catheter for another medical condition. Women with a neurological disease with bladder manifestations (examples: Cerebrovascular accidents, Multiple sclerosis, Parkinson disease, cerebral palsy). Women with preeclampsia requiring magnesium treatment for seizure prevention. Women with prior PUR Women on anticholinergic medications. Women who are actively being treated for a UTI.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: In Arm 2, women with severe postpartum urinary retention will be randomized to 3 or 7 days of foley catheter.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: GROUP 1 (NonSevere PUR and women without PUR)<br>Women in GROUP 1 will be prospectively observed to characterize their clinical outcomes. | |
| Experimental: GROUP 2 (Severe PUR)<br>Women in GROUP 2 will be a randomized to either 3 or 7 days of indwelling catheterization. | Other: Duration of Indwelling Catheter<br>* Foley catheter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate whether 3 days of indwelling catheterization is inferior to 7 days in resolving postpartum urinary retention. |  | 1 year |