Optimizing the Management of Postpartum Urinary Retention

Urinary Retention Clinical Trial

— PUR  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04187365
• Other study ID #: STU00210382
• Status: Terminated
• Phase: N/A
• Start date: November 22, 2019
• Est. completion date: February 27, 2022

Study information

• Verified date: April 2022
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 70
• Est. completion date: February 27, 2022
• Est. primary completion date: February 27, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Urinary Retention

Intervention

Other:
• Duration of Indwelling Catheter
Foley catheter

Locations

Country	Name	City	State
United States	Northwestern Medicine	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate whether 3 days of indwelling catheterization is inferior to 7 days in resolving postpartum urinary retention.		1 year