search
Back to results

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
Atrium Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystocele focused on measuring postoperative, Catheterization, colporrhaphy, cystocele, cystitis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

First Posted
February 13, 2008
Last Updated
February 13, 2008
Sponsor
Atrium Medical Center
Collaborators
Maastricht University
search

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

Learn more about this trial

Postoperative Catheterization After Anterior Colporrhaphy

We'll reach out to this number within 24 hrs