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Optimizing the Management of Postpartum Urinary Retention

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04187365
Acronym
PUR
Enrollment
70
Registered
2019-12-05
Start date
2019-11-22
Completion date
2022-02-27
Last updated
2022-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Retention

Brief summary

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

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

Interventions

OTHERDuration of Indwelling Catheter

Foley catheter

Sponsors

Northwestern University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Masking description

No masking.

Intervention model description

In Arm 2, women with severe postpartum urinary retention will be randomized to 3 or 7 days of foley catheter.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
To evaluate whether 3 days of indwelling catheterization is inferior to 7 days in resolving postpartum urinary retention.1 year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026