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 |
| Protocol serial number | 2002/42-21 |
| Sponsor | Medical University of Innsbruck, Department of Urology (Austria) |
| Funders | Innovacell Biotechnologie (Austria), FWF Austrian Science Fund (Fonds zur Foerderung der wissenschaftlichen Forschung) (ref: P-12828) |
- 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
Scientific
Department of Urology
medical University of Innsbruck
Anichstrasse 35
Innsbruck
6020
Austria
| Georg.Bartsch@uki.at |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective randomized controlled trial. |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Incontinence 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) studied | Urinary incontinence |
| Intervention | Transurethral ultrasound guided injection of autologus myo- and fibroblasts versus transurethral endoscopic injection of collagen. |
| Intervention type | Other |
| Primary outcome measure(s) |
The following were assessed pre-operatively and 3 and 12 months post-operatively: |
| Key secondary outcome measure(s) |
The following were assessed pre-operatively and 3 and 12 months post-operatively: |
| Completion date | 12/05/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 63 |
| Key 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 |
| Key exclusion criteria | 1. Marked hypermobility 2. Urge incontinence |
| Date of first enrolment | 01/09/2002 |
| Date of final enrolment | 12/05/2005 |
Locations
Countries of recruitment
- Austria
Study participating centre
Department of Urology
Innsbruck
6020
Austria
6020
Austria
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 |
