Stress Urinary Incontinence
Conditions
Keywords
Stress Urinary Incontinence, Mesenchymal stem cells
Brief summary
Treatment of women with stress urinary incontinence using injection of autologous adipose-derived mesenchymal stem cells mixed with collagen gel
Detailed description
During the implementation of the project, method for the treatment of women stress urinary incontinence using injection of autologous adipose-derived mesenchymal stem cells mixed with collagen was developed. 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 stress urinary incontinence (SUI) in animals (female rats). After gynecological examination, diagnosis of SUI, MSCs were isolated from adipose tissue, cultured and then transplanted back to directly under mucosa of urethra by three point injection in one third distal from the urethral neck at 3, 6 and 9 o'clock and to the paraurethral area. Injected volume was 3 ml per patient. For injection MSCs (6\*10\^6 cells) were mixed with collagen solution (3,5% w\|w). Follow up patients monitoring was mperformed at 2, 4, 6 and 12 months after injection.
Interventions
Autologous adipose-derived mesenchymal stem cells mixed with collagen solution
Standard treatment according to the Clinical protocols
Sponsors
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
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Stress urinary incontinence * absence of acute inflammatory manifestations in the genitourinary system
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