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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
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
-
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.