RCT About Two Different Regimens of Clean Intermittent Ca... | NCT05188963

Studies
RCT About Two Different Regimens of Clean Intermittent Catheterization in Women With Overt Postpartum Urinary Retention

NCT05188963

Sponsor

Medical University of Vienna

Status

Unknown status

Last Update Posted

Mar 15, 2023Actual

Enrollment

96Estimated

Phase

Not Applicable

Conditions

Urinary Retention
Postpartum Period

Interventions

Intermittent catheterization

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 29, 2021Actual

Primary Completion Date

Jun 28, 2025Estimated

Completion Date

Jun 28, 2025Estimated

First Submitted Date

Dec 27, 2021

First Submission Date that Met QC Criteria

Jan 11, 2022

First Posted Date

Jan 12, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 14, 2023

Last Update Posted Date

Mar 15, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Soren Lange, Fellow, Principal Investigator, M.D., Medical University of ViennaPrincipal Investigator

Lead Sponsor

Medical University of ViennaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A randomized controlled trial of two different regimens of intermittent catheterization in women with overt postpartum urinary retention.

Participants will be randomized to one of two groups with different cut-offs for accepted postvoid residual urine (150 ml vs 250 ml).

Primary endpoint is be the time to regain normal bladder function in each group. Secondary endpoints are 1) presence/absence of bacteriuria or urinary tract infections, 2) the duration of hospital stay, 3) scores on the adapted version of the German pelvic floor questionnaire section about bladder function and postpartum symptoms.

The calculated sample size is 96 (48 in each group).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

96Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Women with postvoid residual volume cut-off at 150 ml	Active Comparator		Procedure: Intermittent catheterization
Women with postvoid residual volume cut-off at 250 ml	Experimental		Procedure: Intermittent catheterization

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intermittent catheterization	Procedure	Intermittent catheterization is performed as treatment for urinary retention. Treatment is stopped when postvoid urinary retention volume is below the threshold of each group.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to regain normal bladder function	The time until bladder function returned to normal.	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosed overt postpartum urinary retention.
Age ≥ 18 years at delivery date.
Delivery at study site.
signed informed consent.

Exclusion Criteria:

Refusal to participate.
Language barrier.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sören Lange, Dr.med.	Contact	+43 (0)1-40400-29150		soeren.lange@meduniwien.ac.at

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University of Vienna/Allgemeines Krankenhaus Wien	Recruiting	Vienna		1090	Austria

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016055	Urinary Retention

Ancestor Terms

ID	Term
D014555	Urination Disorders
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D057928	Intermittent Urethral Catheterization

Ancestor Terms

ID	Term
D014546	Urinary Catheterization
D002404	Catheterization
D013812	Therapeutics
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided