Postoperative Catheterization After Anterior Colporrhaphy

NCT ID: NCT00622076

Last Updated: 2008-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2009-12-31

Brief Summary

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Randomised controled multicenter trial about the appropriate length of postoperative catheterization after anterior colporrhaphy. Patients are included at the moment that they are planned for surgery and are allocated to one of the study arms after the operation in the recovery by a digital randomisation-procedure. 230 patients will be enrolled in the study and half of the patients will have a catheter during five days postoperatively and the other half will be catheterized only during two days. Main outcome measurements regards replacement of a catheter because of bladder retention and the occurence of cystitis.

Detailed Description

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Conditions

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Cystocele Cystitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

postoperative catheterization after anterior colporrhaphy during five days.

Group Type ACTIVE_COMPARATOR

postoperative catheterization

Intervention Type PROCEDURE

postoperative catheterization after anterior colporrhaphy for five days versus two days.

2.

postoperative catheterization after anterior colporrhaphy during two days

Group Type ACTIVE_COMPARATOR

postoperative catheterization

Intervention Type PROCEDURE

postoperative catheterization after anterior colporrhaphy for five days versus two days.

Interventions

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postoperative catheterization

postoperative catheterization after anterior colporrhaphy for five days versus two days.

Intervention Type PROCEDURE

Other Intervention Names

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catheterization protocol

Eligibility Criteria

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Inclusion Criteria

* all patients planned for a cystocele repair

Exclusion Criteria

* patients who already have voiding problems before the operation not related to the cystocele
* patients that are not capable of understanding our patient information form because of mental status or language
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Maastricht University

OTHER

Sponsor Role collaborator

Atrium Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Atrium medical center Heerlen

Principal Investigators

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Frans Roumen, Dr

Role: STUDY_DIRECTOR

Atrium Medical Center

Mirjam Weemhoff, DRS

Role: PRINCIPAL_INVESTIGATOR

Maastricht University

Locations

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atriumMC

Heerlen, , Netherlands

Site Status RECRUITING

Maastricht university medical center

Maastricht, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Mirjam Weemhoff, Drs

Role: CONTACT

+31433876747

Paul Kampschöer, Drs

Role: CONTACT

Facility Contacts

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Martine Wassen, Drs

Role: primary

+31454766666

Paul Kampschöer, Drs

Role: backup

+31455766666

Mirjam Weemhoff, Drs

Role: primary

References

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Ellahi A, Stewart F, Kidd EA, Griffiths R, Fernandez R, Omar MI. Strategies for the removal of short-term indwelling urethral catheters in adults. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD004011. doi: 10.1002/14651858.CD004011.pub4.

Reference Type DERIVED
PMID: 34184246 (View on PubMed)

Other Identifiers

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05-P-47

Identifier Type: -

Identifier Source: org_study_id

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