Condition category
Urological and Genital Diseases
Date applied
27/11/2008
Date assigned
16/01/2009
Last edited
16/03/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ute Kringel

ORCID ID

Contact details

Department of Obstetrics and Gynaecology
University of Rostock
Suedring 81
Rostock
18059
Germany
+49 381 4401 4700
ute.kringel@uni-rostock.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1

Study information

Scientific title

Comparison of the postoperative rate of complications and infections in indwelling urinary catheters and suprapubic catheters after anterior colporrhaphia: a three-arm prospective randomised trial

Acronym

Study hypothesis

Suprapubic (Arm C) and indwelling urinary catheters (IUCs) for 96 hours (Arm B) are preferred in Europe after operations, including anterior colporrhaphia.

Hypothesis 1: If there is no difference in infection or complication rate between IUCs for 96 hours (Arm B) and IUCs for 24 hours (Arm A), the latter will be considered sufficient.
Hypothesis 2: If IUCs for 24 hours (Arm A) have no higher rate of infections and complications compared to suprapubic catheter for 96 hours (Arm C), the former could be considered sufficient.

Ethics approval

Ethics Committee of the Medical Faculty, Institute of Forensic Medicine, University of Rostock, approved on 02/02/2007 (ref: HV 03/2007)

Study design

Randomised controlled single-centre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Urinary tract infection after operation

Intervention

Method of randomisation: permutated block randomisation with variable block length
Duration of recruitment: 12 months

Arm A: IUCs for 24 hours
Arm B: IUCs for 96 hours
Arm C: suprapubic catheter for 96 hours

In Arm A and B the indwelling catheter was installed under sterile conditions preoperatively by a scrub nurse. In Arm C the catheter was inserted under sterile conditions directly after theatre by the performing surgeon.

Total duration of follow-up: until discharge (mean value: 6.85 days +/- 1.45).

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Rate of urinary tract infection at 4 days after operation.

Secondary outcome measures

Complications, assessed on the day of discharge (mean value: 6.85 days +/- 1.45).

Overall trial start date

01/03/2007

Overall trial end date

29/02/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Female patients
2. 45-85 year old
3. Patients with a planned anterior colporrhaphia
4. Patient's consent
5. Urine analysis and urine culture immediately before and 4 days after the operation

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

300

Participant exclusion criteria

1. Symptomatic urinary tract infection preoperatively
2. Epidural anaesthesia

Recruitment start date

01/03/2007

Recruitment end date

29/02/2008

Locations

Countries of recruitment

Germany

Trial participating centre

Department of Obstetrics and Gynaecology
Rostock
18059
Germany

Sponsor information

Organisation

University of Rostock (Germany)

Sponsor details

Medical Faculty
Department of Obstetrics and Gynaecology
Suedring 81
Rostock
18059
Germany
+49 381 4401 4500
bernd.gerber@med.uni-rostock.de

Sponsor type

University/education

Website

http://www.kliniksued-rostock.de/klinikum/

Funders

Funder type

University/education

Funder name

University of Rostock (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. Kringel U, Gerber B: Comparision of the postoperative rate of complications and infections in indwelling urinary catheters and suprapubic catheters after anterior kolporrhaphia: a 3-arm prospective randomised trial. Interim analysis after 30 patients. Poster presentation. North German Society of Obstetrics and Gynaecology (NGGG) meeting, Göttingen, 7th - 9th September 2007 (http://www.nggg2007.de/)
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20683580

Publication citations

  1. Results

    Kringel U, Reimer T, Tomczak S, Green S, Kundt G, Gerber B, Postoperative infections due to bladder catheters after anterior colporrhaphy: a prospective, randomized three-arm study., Int Urogynecol J, 2010, 21, 12, 1499-1504, doi: 10.1007/s00192-010-1221-2.

Additional files

Editorial Notes