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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04187365
Other study ID # STU00210382
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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