Autologous myoblasts and fibroblasts versus collagen for treatment of stress urinary incontinence in women: a randomised trial

ISRCTN ISRCTN71247587
DOI https://doi.org/10.1186/ISRCTN71247587
Secondary identifying numbers 2002/42-21
Submission date
19/06/2007
Registration date
16/07/2007
Last edited
03/10/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Georg Bartsch
Scientific

Department of Urology
medical University of Innsbruck
Anichstrasse 35
Innsbruck
6020
Austria

Email Georg.Bartsch@uki.at

Study information

Study designProspective randomized controlled trial.
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesIncontinence can be better treated with ultrasound-guided application of autologous cells than with standard endoscopic collagen injectons.
Ethics approval(s)Austrian Ministry of Health. Date of approval: 27th August 2002 (ref: GZ 2.481.159/1-VI/A/4/02)
Health condition(s) or problem(s) studiedUrinary incontinence
InterventionTransurethral ultrasound guided injection of autologus myo- and fibroblasts versus transurethral endoscopic injection of collagen.
Intervention typeOther
Primary outcome measureThe following were assessed pre-operatively and 3 and 12 months post-operatively:
1. Incontinence score
2. Ultrasound parameters
Secondary outcome measuresThe following were assessed pre-operatively and 3 and 12 months post-operatively:
1. Quality of life
2. Urodynamic parameters
Overall study start date01/09/2002
Completion date12/05/2005

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants63 women
Key inclusion criteria1. Women who were admitted to Department of Urology, Medical University of Innsbruck, Austria with stress incontinence.
2. Aged between 35 and 85 years
Key exclusion criteria1. Marked hypermobility
2. Urge incontinence
Date of first enrolment01/09/2002
Date of final enrolment12/05/2005

Locations

Countries of recruitment

  • Austria

Study participating centre

Department of Urology
Innsbruck
6020
Austria

Sponsor information

Medical University of Innsbruck, Department of Urology (Austria)
University/education

Anichstrasse 35
Innsbruck
6020
Austria

Email hannes.strasser@uibk.ac.at
ROR logo "ROR" https://ror.org/054pv6659

Funders

Funder type

Industry

Innovacell Biotechnologie (Austria)

No information available

FWF Austrian Science Fund (Fonds zur Foerderung der wissenschaftlichen Forschung) (ref: P-12828)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article Results 30/06/2007 Yes No