Stress urinary incontinence
Saraluck 2023Autologous platelet rich plasma (A-PRP) combined with pelvic floor muscle training for the treatment of female stress urinary incontinence (SUI): A randomized control clinical trial.
There is growing interest in the use of several innovative technologies being routinely used for facial skin care and skin rejuvenation for the treatment of genital disorders resulting from the aging process or with inflammation-related origins. This includes the use of PRP.
Stress urinary incontinence (SUI) is usually the result of the weakening of, or damage to, the muscles used to prevent urination, such as the pelvic floor muscles and the urethral sphincter. Its prevalence is estimated to 40% of adult women
OBJECTIVE
Compare the efficacy of RegenPRP™ combined with pelvic floor muscle training (PFMT) versus PFMT alone in treating female stress urinary incontinence (SUI).
PROTOCOL
Randomized clinical trial on 60 women with previously untreated SUI. All patients performed PFMT 3 times daily. In addition, a group of 31 patients received 2 treatments with RegenPRP™ with a monthly interval. Five ml of RegenPRP™ were injected into the anterior vaginal mucosa around the patient’s mid-urethral area: 2 ml underneath mid-urethra and 1.5 mL on either side of mid urethra using a 27-gauge needle.
SAFETY
No adverse effects of RegenPRP™ injection were noted after completion of the study.
RESULTS
After 5 months of treatment (3 months after the second injection), the RegenPRP™ + PFMT group showed a significant decrease (p=0.02) in 1-hour pad weight test results compared to the PFMT alone group (-8.8 g vs -0.8 g, respectively, (see figure 2). Secondary outcomes, improvements in quality of life (I-QoL scores) and symptom severity (ICIQ FLUTS scores), were also significantly better in the RegenPRP™ + PFMT group. Self-reported percentage subjective improvement showed that 90% of patients in the RegenPRP™ + PFMT group experienced an improvement in SUI of at least 50%. In contrast, only 14% of patients in the PFMT group achieved a similar level of improvement.
Greater reduction in pad weight
Change from baseline at the reported 5-month follow-up.
Bar length represents the magnitude of the reduction in grams. A larger reduction indicates less leakage on the pad test.
P = 0.02Comparison reported in the brochure. These values are changes, not final pad weights.
At least 50% improvement in SUI
Percentage of patients reporting a subjective improvement of at least 50%.
Reported percentages at follow-up; exact responder counts are not supplied on this page. This is a subjective improvement threshold, not a cure rate.
Quality of life and symptom severity
- I-QoL: greater improvement in incontinence-related quality of life.
- ICIQ-FLUTS: greater improvement in lower urinary tract symptom severity.
Both outcomes were reported as significantly better with RegenPRP™ + PFMT than with PFMT alone. Exact score changes and P values are not provided on the supplied page.
No injection-related adverse effects reported
No adverse effects of RegenPRP™ injection were noted after completion of the study, according to the brochure.
This observation applies to this study and follow-up period; it does not establish that treatment is risk-free.
1-hour pad weight test
Baseline and 5-month follow-up · PFMT alone vs RegenPRP™ + PFMT
Source: RegenPRP™ Therapy Gynaecology, p. 7; Saraluck et al., Neurourology and Urodynamics (2024), 43(2):342–353.
For healthcare professionals only
CONCLUSION
The combined treatment of RegenPRP™ and PFMT is promising in terms of efficacy and safety for treating female stress urinary incontinence. The study is the first to compare the efficacy of PRP + PFMT with PFMT alone, offering new insights into the treatment of female stress urinary incontinence.