Trial record 1 of 6 for:
Open Studies | cystocele
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
Recruitment status was Recruiting
Sponsor:
Atrium Medical Center
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
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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
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 Urinary Bladder Diseases Urologic Diseases |
Pelvic Organ Prolapse Prolapse Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on May 16, 2013