Postoperative Catheterization After Anterior Colporrhaphy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by Atrium Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Maastricht University
Information provided by:
Atrium Medical Center
ClinicalTrials.gov Identifier:
NCT00622076
First received: February 13, 2008
Last updated: NA
Last verified: January 2008
History: No changes posted
  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: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomised Controled Multicenter Trial Regarding the Appropriate Length of Postoperative Catheterization After Anterior Colporrhaphy for Repair of Cystocele

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
Active Comparator: 1
postoperative catheterization after anterior colporrhaphy during five days.
Procedure: postoperative catheterization
postoperative catheterization after anterior colporrhaphy for five days versus two days.
Other Name: catheterization protocol
Active Comparator: 2.
postoperative catheterization after anterior colporrhaphy during two days
Procedure: postoperative catheterization
postoperative catheterization after anterior colporrhaphy for five days versus two days.
Other Name: catheterization protocol

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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

Keywords provided by Atrium Medical Center:
postoperative
Catheterization
colporrhaphy
cystocele
cystitis

Additional relevant MeSH terms:
Cystitis
Cystocele
Pathological Conditions, Anatomical
Pelvic Organ Prolapse
Prolapse
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on October 23, 2014