Primary objective: To confirm the safety of the use of Urocell as a treatment for stress incontinence due to intrinsic sphinctre deficiency.Secondary ojectives: - To score the quelity of life with a standardized questionnaire and to score the level…
ID
Source
Brief title
Condition
- Urethral disorders (excl calculi)
- Lifestyle issues
- Renal and urinary tract therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
(Serious) Adverse Events, abnormalities found in the physical examination,
occurrence of infection parameters in the blood samples or urine sediment,
abnormalities found in (video) urodynamic investigations, abnormalities found
in endo-MRI, cystoscopy, TUUS, TRUS/TVUS.
Secondary outcome
Change in quality of life (CONTILIFE) or in the Urine Incontinence Score from
baseline to endpoint, change in urodynamic investigations and urethral pressure
profile before and after injection with Urocell.
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, e.g. radical prostatectomy, 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 we hope to show that the
investigational product Urocell can be applied to patients with stress
incontinence in a safe manner.
Study objective
Primary objective:
To confirm the safety of the use of Urocell as a treatment for stress
incontinence due to intrinsic sphinctre deficiency.
Secondary ojectives:
- To score the quelity of life with a standardized questionnaire and to score
the level of incontinence before and after the injection of Urocell.
- To investigate the efficacy on incontinence due to the investigational
product Urocell by the investigations mentioned above.
Study design
This study is a prospective, open, singlecenter 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,
fibroblasts and collagen in medium.
Study burden and risks
Subjects will visit the clinic 8 times in 15 months. Blood samples will be
taken 7 times, urine sediments will be taken 7 times, and a physical
examination will be performed every visit, to adress the safety and adverse
events (if any).
The CONTILIFE (quality of life score) will be taken 5 times, and subjects will
fill in a micurition diary once day of the week for 6 months in total.
The psychological burden is considered minimal because of the possible positive
effect on continence.
Mitterweg 24
6020 Innsbruck
Oostenrijk
Mitterweg 24
6020 Innsbruck
Oostenrijk
Listed location countries
Age
Inclusion criteria
* Verified diagnosis of urinary incontinence by medical history and urodynamics
* Stress urinary incontinence (without severe prolapse of pelvic organs or dominant urgency complaints)
* Lack of improvement of continence after 12 treatments of pelvic floor exercises
* Age from 18 up to and including 75 years
* Life expectancy of 10 years or more
Exclusion criteria
* Any neurological disorder
* Bladder instability during urodynamics and pure urge incontinence
* Men with a sealing defect in the anastomosis (bypass gap in the urethra) following radical prostatectomy as visualised during cystoscopy
* Women with marked prolapse of the pelvic organs or marked hypermobility of the urethra (Q-tip test > 30%)
* Previous treatment with TVT, TOT or bulking agents
* Pregnancy: women in childbearing age can be treated with Urocell, if no pregnancy is diagnosed at admission and if effective contraceptive measures are undertaken pre- and post-operatively (during entire study period)
* Lactating women
* Patient is treated with immunosuppressive medication or any immunosuppressive therapy is intended
* Diagnosis of a malignant disease which is treated or about to be treated with radiotherapy or chemotherapy
* Patients who have had radiotherapy of pelvic organs
* Severe autoimmune disease
* Collagen allergy
* Patient is HIV, Hepatitis B or Hepatitis C positive
* Patients who cannot follow instructions regarding the protocol or cannot fill in the micturition diary, 24 hour pad test, or quality of life questionnaire (CONTILIFE)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2007-001392-11-NL |
| CCMO | NL15785.000.07 |