Optimizing the Management of Postpartum Urinary Retention (PUR)

Northwestern University

Status: Terminated

Conditions: Urinary Retention

Treatments: Other: Duration of Indwelling Catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT04187365

STU00210382

Details and patient eligibility

About

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.

Full description

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

1. 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

2. The incidence of postpartum urinary retention (PUR) will vary by route of delivery, with operative vaginal delivery having the highest incidence.

3. Risk factors for PUR will be related to intrapartum and delivery conditions

Enrollment: 70 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age greater than or equal to 18.
2. Vaginal or cesarean delivery at term (37 weeks gestational age or later) of live-born infants.
3. English or Spanish speaking and reading.

Exclusion criteria

1. Adults unable to consent.
2. Women under the age of 18.
3. Women who are currently pregnant (All women in the study will have already delivered).
4. Prisoners or detained individuals.
5. Women who chronically use a urinary catheter for another medical condition.
6. Women with a neurological disease with bladder manifestations (examples: Cerebrovascular accidents, Multiple sclerosis, Parkinson disease, cerebral palsy).
7. Women with preeclampsia requiring magnesium treatment for seizure prevention.
8. Women with prior PUR
9. Women on anticholinergic medications.
10. Women who are actively being treated for a UTI.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

GROUP 1 (NonSevere PUR and women without PUR)

No Intervention group

Description:

Women in GROUP 1 will be prospectively observed to characterize their clinical outcomes.

GROUP 2 (Severe PUR)

Experimental group

Description:

Women in GROUP 2 will be a randomized to either 3 or 7 days of indwelling catheterization.

Treatment:

Other: Duration of Indwelling Catheter