Condition category
Urological and Genital Diseases
Date applied
19/06/2007
Date assigned
16/07/2007
Last edited
03/10/2008
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

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

  1. 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.

Additional files

Editorial Notes