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Treatment of Postpartum Urinary Retention

Primary Purpose

Retention, Urinary

Status

Completed

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Foley Catheter

About this trial

This is an interventional treatment trial for Retention, Urinary

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Women who deliver at one of the centers included in the study
Overt postpartum urinary retention which refers to the absence of spontaneous micturition within six to eight hours of vaginal delivery; or within six to eight hours following removal of an indwelling catheter after cesarean delivery
Covert postpartum urinary retention diagnosed by ultrasound or catheterization of more than 150cc

Exclusion Criteria:

Spontaneous micturition 6-8 hours following vaginal or cesarean delivery
postpartum urinary retention less than 150cc on ultrasound
Known urinary tract infection

Sites / Locations

Rambam Healthcare Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Intermittent catheterization

Continous catheterization

Arm Description

women who are catheterized intermittently every 6-8 hours up to a total time of 48 hours

women which will have an indwelling catheter inserted for 24 hours

Outcomes

Primary Outcome Measures

Mean time for urinary retention resolution.

Mean time for urinary retention resolution following the intervention.

Secondary Outcome Measures

Urinary tract infection rate

Incidence of Urinary tract infections

Length of hospital stay

Full Information

NCT ID

NCT04104165

First Posted

September 24, 2019

Last Updated

August 12, 2022

Sponsor

Rambam Health Care Campus

1. Study Identification

Unique Protocol Identification Number

NCT04104165

Brief Title

Treatment of Postpartum Urinary Retention

Official Title

Intermittent Versus Continous Catheterization for Treatment of Postpartum Urinary Retention.

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Completed

Study Start Date

January 1, 2020 (Actual)

Primary Completion Date

April 30, 2022 (Actual)

Study Completion Date

May 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rambam Health Care Campus

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The aim of the study is to evaluate what is the most effective catheterization duration to resolve covert and overt postpartum urinary retention following vaginal delivery and caesarean delivery, with the highest patients' satisfaction.

Detailed Description

Women who are unable to micturate for more than 6-8 hours following vaginal delivery or within six to eight hours following removal of an indwelling catheter after cesarean delivery (overt postpartum urinary retention), or women with postvoid residual bladder volume of at least 150 mL (covert postpartum urinary retention) will be randomized into 2 groups: one group will include women who are catheterized intermittently every 6-8 hours up to a total time of 48 hours. If at any time, post voiding residual volume is less than 150cc (assessed by ultrasound or by catheterization), no additional catheterization is needed. The second group will include women which will have an indwelling catheter inserted for 24 hours. The catheter will be removed 24 hours following its insertion and post voiding residual volume will be assessed 6 hours following the catheter removal (by ultrasound or by catheterization). In cases of post voiding residual volume more than 150 cc or women are unable to micturate spontaneously, an indwelling catheter will be inserted for additional 24 hours. After 48 hours from postpartum urinary retention diagnosis, an indwelling catheter will be inserted for additional time that will be set at every center by its common protocol.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Retention, Urinary

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

146 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intermittent catheterization

Arm Type

Active Comparator

Arm Description

women who are catheterized intermittently every 6-8 hours up to a total time of 48 hours

Arm Title

Continous catheterization

Arm Type

Active Comparator

Arm Description

women which will have an indwelling catheter inserted for 24 hours

Intervention Type

Device

Intervention Name(s)

Foley Catheter

Intervention Description

Foley catheter used for treatment of urinary retention

Primary Outcome Measure Information:

Title

Mean time for urinary retention resolution.

Description

Mean time for urinary retention resolution following the intervention.

Time Frame

Up to 10 days from diagnosis

Secondary Outcome Measure Information:

Title

Urinary tract infection rate

Description

Incidence of Urinary tract infections

Time Frame

Up to 96 hours from diagnosis

Title

Length of hospital stay

Description

Length of hospital stay

Time Frame

Up to 96 hours from diagnosis

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

Female patients

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Women who deliver at one of the centers included in the study Overt postpartum urinary retention which refers to the absence of spontaneous micturition within six to eight hours of vaginal delivery; or within six to eight hours following removal of an indwelling catheter after cesarean delivery Covert postpartum urinary retention diagnosed by ultrasound or catheterization of more than 150cc Exclusion Criteria: Spontaneous micturition 6-8 hours following vaginal or cesarean delivery postpartum urinary retention less than 150cc on ultrasound Known urinary tract infection

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Roy Lauterbach, MD

Organizational Affiliation

Rambam Healthcare Campus

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rambam Healthcare Campus

City

Haifa

Country

Israel

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Treatment of Postpartum Urinary Retention

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