CystoceleNCT00622076
Postoperative Catheterization After Anterior Colporrhaphy
A study testing postoperative catheterization in people with Cystocele and Cystitis, run by Atrium Medical Center at 2 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- What is being tested?
- postoperative catheterization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 2 sitesNetherlands
- Study dates
- Jan 2006to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- all patients planned for a cystocele repair
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites, 2 recruiting
- Recruiting
atriumMC
Heerlen, 6401 CX
Martine Wassen, Drs, +31454766666
Paul Kampschöer, Drs, +31455766666
- Recruiting
Maastricht university medical center
Maastricht, 6229 HC
Mirjam Weemhoff, Drs
Mirjam Weemhoff, Drs
About this study
Official title: Randomised Controled Multicenter Trial Regarding the Appropriate Length of Postoperative Catheterization After Anterior Colporrhaphy for Repair of Cystocele
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.
- Being tested
- postoperative catheterization
- Keywords
- postoperative, Catheterization, colporrhaphy, cystocele, cystitis
- Medical subject headings
- Cystocele, Cystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
postoperative catheterizationProcedure or surgery
Also called catheterization protocol
postoperative catheterization after anterior colporrhaphy for five days versus two days.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | postoperative catheterization after anterior colporrhaphy during five days. Receives: Procedure: postoperative catheterization |
| 2. | Active comparator | postoperative catheterization after anterior colporrhaphy during two days Receives: Procedure: postoperative catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 6 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2008 (estimated)
- Study startJan 2006
- Primary completionJun 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CystoceleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atrium Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Maastricht University
- Investigators
- Frans Roumen, Dr, Study director, Atrium Medical CenterMirjam Weemhoff, DRS, Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00622076
- Sponsor's protocol ID
- 05-P-47
- Status last verified
- Jan 2008
- First submitted
- 13 Feb 2008
- Last updated
- 22 Feb 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 34184246
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controled Multicenter Trial Regarding the Appropriate Length of Postoperative Catheterization After Anterior Colporrhaphy for Repair of Cystocele
- ClinicalTrials.gov ID
- NCT00622076
- Acronym / sponsor ID
- 05-P-47
- Keywords
- postoperative, Catheterization, colporrhaphy, cystocele, cystitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Atrium Medical CenterUniversity, hospital or other
- Collaborators
- Maastricht University
- Study start
- Jan 2006
- Primary completion
- Jun 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 22 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: postoperative catheterizationpostoperative catheterization after anterior colporrhaphy during five days. |
| 2. | Active comparator | Procedure: postoperative catheterizationpostoperative catheterization after anterior colporrhaphy during two days |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- all patients planned for a cystocele repair
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| postoperative catheterizationAlso: catheterization protocolpostoperative catheterization after anterior colporrhaphy for five days versus two days. | Procedure or surgery | 1, 2. |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2008.
- Derived from this study: PubMed 34184246Ellahi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frans Roumen, Dr study director
Atrium Medical Center
Mirjam Weemhoff, DRS principal investigator
Maastricht University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing postoperative catheterization in people with Cystocele and Cystitis, run by Atrium Medical Center at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mirjam Weemhoff, Drs (+31433876747, mwee@sgyn.azm.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00622076, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2008.