Urinary Incontinence
Conditions
Keywords
Urinary incontinence, Prostatectomy
Brief summary
Treatment of patients with urinary incontinence after prostatectomy using injection of autologous adipose-derived mesenchymal stem cells mixed with collagen gel
Detailed description
During the implementation of the project, it is planned to develop a method for the treatment of men urinary incontinence caused by prostatectomy using injection of autologous adipose-derived mesenchymal stem cells mixed with collagen. The positive outlook for the effectiveness of MSCs is due to the following: * the ability of MSCs to stimulate tissue regeneration * positive results of preclinical studies of the method of treatment of urinary incontinence in animals. In study planing to include 5 patients. MSCs will be isolated from adipose tissue, cultured and then transplanted back to the periurethral area by five point injection in rhabdosphincter and submucosal space of urethra using the cystourethroscope. For injection in submucosal space MSCs (20\*10\^6 cells) will be mixed with collagen solution (3,5% w\|w). Follow up patients monitoring will occur at 1，3，6 and 12 months after injection.
Interventions
Autologous adipose-derived mesenchymal stem cells mixed with collagen solution injected in submucosal space
Standard treatment according to the Clinical protocols
Sponsors
N.N. Alexandrov National Cancer Centre
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Urinary incontinence * absence of acute inflammatory manifestations in the genitourinary system * period after prostatectomy is at least 12 months
Exclusion criteria
* urethral or bladder malformations * acute and chronic infectious diseases: HIV, viral hepatitis, tuberculosis * mental disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of cured patients | 3 months | Number of patients cured |
| Number of patients with treatment-related adverse events | 4 weeks | MSC application related adverse events assessed by blood count, liver and function tests |
Countries
Belarus
Outcome results
None listed