Postoperative Catheterization After Anterior Colporrhaphy
Primary Purpose
Cystocele, Cystitis
Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
postoperative catheterization
Sponsored by
About this trial
This is an interventional treatment trial for Cystocele focused on measuring postoperative, Catheterization, colporrhaphy, cystocele, cystitis
Eligibility 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
Sites / Locations
- atriumMCRecruiting
- Maastricht university medical centerRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2.
Arm Description
postoperative catheterization after anterior colporrhaphy during five days.
postoperative catheterization after anterior colporrhaphy during two days
Outcomes
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
Secondary Outcome Measures
how many patients develop cystitis after catheterization in both groups: 2 days versus 5 days in dwelling catheterization after anterior colporrhaphy
Full Information
NCT ID
NCT00622076
First Posted
February 13, 2008
Last Updated
February 13, 2008
Sponsor
Atrium Medical Center
Collaborators
Maastricht University
1. Study Identification
Unique Protocol Identification Number
NCT00622076
Brief Title
Postoperative Catheterization After Anterior Colporrhaphy
Official Title
Randomised Controled Multicenter Trial Regarding the Appropriate Length of Postoperative Catheterization After Anterior Colporrhaphy for Repair of Cystocele
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Unknown status
Study Start Date
January 2006 (undefined)
Primary Completion Date
June 2009 (Anticipated)
Study Completion Date
December 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Atrium Medical Center
Collaborators
Maastricht University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystocele, Cystitis
Keywords
postoperative, Catheterization, colporrhaphy, cystocele, cystitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
230 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
postoperative catheterization after anterior colporrhaphy during five days.
Arm Title
2.
Arm Type
Active Comparator
Arm Description
postoperative catheterization after anterior colporrhaphy during two days
Intervention Type
Procedure
Intervention Name(s)
postoperative catheterization
Other Intervention Name(s)
catheterization protocol
Intervention Description
postoperative catheterization after anterior colporrhaphy for five days versus two days.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mirjam Weemhoff, Drs
Phone
+31433876747
Email
mwee@sgyn.azm.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Paul Kampschöer, Drs
Phone
+31454766666
Email
p.kampschöer@atriummc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frans Roumen, Dr
Organizational Affiliation
Atrium Medical Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mirjam Weemhoff, DRS
Organizational Affiliation
Maastricht University
Official's Role
Principal Investigator
Facility Information:
Facility Name
atriumMC
City
Heerlen
ZIP/Postal Code
6401 CX
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martine Wassen, Drs
Phone
+31454766666
First Name & Middle Initial & Last Name & Degree
Paul Kampschöer, Drs
Phone
+31455766666
First Name & Middle Initial & Last Name & Degree
Martine Wassen, Drs
Facility Name
Maastricht university medical center
City
Maastricht
ZIP/Postal Code
6229 HC
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mirjam Weemhoff, Drs
First Name & Middle Initial & Last Name & Degree
Mirjam Weemhoff, Drs
12. IPD Sharing Statement
Citations:
PubMed Identifier
34184246
Citation
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.
Results Reference
derived
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Postoperative Catheterization After Anterior Colporrhaphy
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