Postoperative Catheterization After Anterior Colporrhaphy - Full Text View

Sponsors and Collaborators:	Atrium Medical Center Maastricht University Medical Center
Information provided by:	Atrium Medical Center
ClinicalTrials.gov Identifier:	NCT00622076

Purpose

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.

Condition	Intervention
Cystocele Cystitis	Procedure: postoperative catheterization

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment
Official Title:	Randomised Controled Multicenter Trial Regarding the Appropriate Length of Postoperative Catheterization After Anterior Colporrhaphy for Repair of Cystocele

Resource links provided by NLM:

MedlinePlus related topics: Bladder Diseases

U.S. FDA Resources

Further study details as provided by Atrium Medical Center:

Primary Outcome Measures:

how many patients do need replacement of a catheter because of urine retention in both groups: 2 days versus 5 days in dwelling catheterization after anterior colporrhaphy [ Time Frame: 6-8 hours after removal of catheter ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

how many patients develop cystitis after catheterization in both groups: 2 days versus 5 days in dwelling catheterization after anterior colporrhaphy [ Time Frame: 6 weeks after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment:	230
Study Start Date:	January 2006
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator postoperative catheterization after anterior colporrhaphy during five days.	Procedure: postoperative catheterization postoperative catheterization after anterior colporrhaphy for five days versus two days.
2.: Active Comparator postoperative catheterization after anterior colporrhaphy during two days	Procedure: postoperative catheterization postoperative catheterization after anterior colporrhaphy for five days versus two days.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00622076

Contacts

Contact: Mirjam Weemhoff, Drs	+31433876747	mwee@sgyn.azm.nl
Contact: Paul Kampschöer, Drs	+31454766666	p.kampschöer@atriummc.nl

Locations

Netherlands
atriumMC	Recruiting
Heerlen, Netherlands, 6401 CX
Contact: Martine Wassen, Drs +31454766666
Contact: Paul Kampschöer, Drs +31455766666
Sub-Investigator: Martine Wassen, Drs
Maastricht university medical center	Recruiting
Maastricht, Netherlands, 6229 HC
Contact: Mirjam Weemhoff, Drs
Principal Investigator: Mirjam Weemhoff, Drs

Sponsors and Collaborators

Atrium Medical Center

Maastricht University Medical Center

Investigators

Study Director:	Frans Roumen, Dr	Atrium Medical Center
Principal Investigator:	Mirjam Weemhoff, DRS	Maastricht University Medical Center

More Information

No publications provided

Responsible Party:	Atrium medical center Heerlen ( Weemhoff )
Study ID Numbers:	05-P-47
Study First Received:	February 13, 2008
Last Updated:	February 13, 2008
ClinicalTrials.gov Identifier:	NCT00622076 History of Changes
Health Authority:	Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Atrium Medical Center:

postoperative
Catheterization
colporrhaphy
cystocele
cystitis

Study placed in the following topic categories:

Cystocele
Urologic Diseases
Urinary Bladder Diseases
Cystitis

Additional relevant MeSH terms:

Cystocele
Urologic Diseases
Urinary Bladder Diseases
Cystitis

ClinicalTrials.gov processed this record on September 03, 2009