Contact information
Type
Scientific
Primary contact
Prof Georg Bartsch
ORCID ID
Contact details
Department of Urology
medical University of Innsbruck
Anichstrasse 35
Innsbruck
6020
Austria
Georg.Bartsch@uki.at
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2002/42-21
Study information
Scientific title
Acronym
Study hypothesis
Incontinence can be better treated with ultrasound-guided application of autologous cells than with standard endoscopic collagen injectons.
Ethics approval
Austrian Ministry of Health. Date of approval: 27th August 2002 (ref: GZ 2.481.159/1-VI/A/4/02)
Study design
Prospective randomized controlled trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Urinary incontinence
Intervention
Transurethral ultrasound guided injection of autologus myo- and fibroblasts versus transurethral endoscopic injection of collagen.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
The following were assessed pre-operatively and 3 and 12 months post-operatively:
1. Incontinence score
2. Ultrasound parameters
Secondary outcome measures
The following were assessed pre-operatively and 3 and 12 months post-operatively:
1. Quality of life
2. Urodynamic parameters
Overall trial start date
01/09/2002
Overall trial end date
12/05/2005
Reason abandoned
Eligibility
Participant inclusion criteria
1. Women who were admitted to Department of Urology, Medical University of Innsbruck, Austria with stress incontinence.
2. Aged between 35 and 85 years
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
63 women
Participant exclusion criteria
1. Marked hypermobility
2. Urge incontinence
Recruitment start date
01/09/2002
Recruitment end date
12/05/2005
Locations
Countries of recruitment
Austria
Trial participating centre
Department of Urology
Innsbruck
6020
Austria
Sponsor information
Organisation
Medical University of Innsbruck, Department of Urology (Austria)
Sponsor details
Anichstrasse 35
Innsbruck
6020
Austria
hannes.strasser@uibk.ac.at
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
Innovacell Biotechnologie (Austria)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
FWF Austrian Science Fund (Fonds zur Foerderung der wissenschaftlichen Forschung) (ref: P-12828)
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
Results in http://www.ncbi.nlm.nih.gov/pubmed/17604800 - please note that this paper was retracted from the Lancet on 6th September 2008 after allegations of misconduct
Publication citations
-
Strasser H, Marksteiner R, Margreiter E, Pinggera GM, Mitterberger M, Frauscher F, Ulmer H, Fussenegger M, Kofler K, Bartsch G, Autologous myoblasts and fibroblasts versus collagen for treatment of stress urinary incontinence in women: a randomised controlled trial., Lancet, 2007, 369, 9580, 2179-2186, doi: 10.1016/S0140-6736(07)61014-9.