The objective of the study is to ascertain whether the high effect sizes obtained in the previous studies can be explained according to our working hypothesis, i.e. whether the intervention with Urocell is associated with a structural regeneration…
ID
Source
Brief title
Condition
- Bladder and bladder neck disorders (excl calculi)
- Renal and urinary tract therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Improvement of the urinary incontinence score.
Secondary outcome
- Urodynamics: function of the urinary vesicle and the urethral closure
pressure pre- and post-therapy.
- Sonography and elastography of the urethra: the urethra, contractility of the
rhabdosphincter, thickness and morphology of the rhabdosphincter before and
after therapy.
- Contilife questionnaire
Background summary
Urinary incontinence is a frequent health problem. The contribution of stress
incontinence to the overall prevalence of incontinence is major, especially in
women. An age-related weakening of the sphincter muscle is the most frequent
cause for urinary incontinence, but also traumatisation of this structure due
to operations or child delivery play the main role. Up to now, a satisfying
solution of the problem * for the patient as well as the physician * was not
generally achievable. Most methods led to inefficient or only short-time
results, or were incriminated by unacceptable side effects.
Because incontinence has a major impact on the (socially) functioning of
patients, it is important to develop a treatment which results in normal
(socially) functioning of patients. With this research and other (already
finalised) researches with Urocell we hope to show that the Urocell-method is a
new, minimally invasive and patient friendly treatment for the causal and
effective treatment of stress incontinence.
Study objective
The objective of the study is to ascertain whether the high effect sizes
obtained in the previous studies can be explained according to our working
hypothesis, i.e. whether the intervention with Urocell is associated with a
structural regeneration and volume increase of the rhabdosphincter muscle
and/or the urethral submucosa.
Study design
This study is a prospective, open, multicenter study in patients with stress
incontinence.
Intervention
A onetime ultrasound-directed intramuscular and intraurethral injection of
Urocell. Urocell is a body*s own product existing of autologous myoblasts and
fibroblasts and collagen. The purpose of the treatment with Urocell is
improving the urinary incontinence by means of causal therapy in patients with
stress incontinence. Secondarily, the aim is an improved quality of life score.
Study burden and risks
Till August 2006, 250 patients with stress incontinence were treated with the
product Urocell. In these patients very good results were accomplished. No
immediate or chronic unwanted effects were observed.
Mitterweg 24
6020 Innsbruck
Oostenrijk
Mitterweg 24
6020 Innsbruck
Oostenrijk
Listed location countries
Age
Inclusion criteria
* Age 18-70 years
* Verified diagnosis of urinary incontinence
* Stress- or mixed urinary incontinence (without severe descensus of pelvic organs or dominant urgency complaints)
Exclusion criteria
* A neurological disorder as the sole reason for the incontinence
* Women with marked descensus of the pelvic organs or marked hypermobility of the urethra
*Pregnancy
* Allergy against collagen
* (Planned) treatment with immunosuppressive medication or any immunosupression therapy
* Previous X-ray treatment of pelvic organs
* Severe autoimmune disease
* Bladder instability and/or pure urge incontinence
* Lactating patients
* Previous treatment with TVT, TOT or bulking agents
* Malignancy treated or apt to be treated by x-ray therapy or chemotherapy
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2006-003214-17-NL |
| CCMO | NL12342.000.06 |