NCT00622076

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
230

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 13, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 22, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

February 22, 2008

Status Verified

January 1, 2008

Enrollment Period

3.4 years

First QC Date

February 13, 2008

Last Update Submit

February 13, 2008

Conditions

CystoceleCystitis

Keywords

postoperativeCatheterizationcolporrhaphycystocelecystitis

Outcome Measures

Primary Outcomes (1)

  • 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

    6-8 hours after removal of catheter

Secondary Outcomes (1)

  • how many patients develop cystitis after catheterization in both groups: 2 days versus 5 days in dwelling catheterization after anterior colporrhaphy

    6 weeks after surgery

Study Arms (2)

1

ACTIVE COMPARATOR

postoperative catheterization after anterior colporrhaphy during five days.

Procedure: postoperative catheterization

2.

ACTIVE COMPARATOR

postoperative catheterization after anterior colporrhaphy during two days

Procedure: postoperative catheterization

Interventions

postoperative catheterizationPROCEDURE

postoperative catheterization after anterior colporrhaphy for five days versus two days.

Also known as: catheterization protocol
12.

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • all patients planned for a cystocele repair

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

atriumMC

Heerlen, 6401 CX, Netherlands

RECRUITING

Maastricht university medical center

Maastricht, 6229 HC, Netherlands

RECRUITING

Related Publications (1)

  • 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.

    PMID: 34184246DERIVED

MeSH Terms

Conditions

CystoceleCystitis

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPelvic Organ ProlapseProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Frans Roumen, Dr

    Atrium Medical Center

    STUDY DIRECTOR

  • Mirjam Weemhoff, DRS

    Maastricht University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mirjam Weemhoff, Drs

CONTACT

+31433876747mwee@sgyn.azm.nl

Paul Kampschöer, Drs

CONTACT

+31454766666p.kampschöer@atriummc.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 13, 2008

First Posted

February 22, 2008

Study Start

January 1, 2006

Primary Completion

June 1, 2009

Study Completion

December 1, 2009

Last Updated

February 22, 2008

Record last verified: 2008-01

Locations

NL(2)