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Treatment with stromal vascular fraction of Peyronie's disease - a study protocol
Majken Højrup Wiborg1,2, Rasmus Krøijer2,3, Birgitte Schantz Laursen4,5
1Department of Urology, Hospital South West Jutland, Region of Southern Denmark.
Introduction:
Peyronie´s disease is the result of an acquired fibrotic plaque in the tunica albuginea. It remains unknown why the condition appears, but it seems to affect up to 9% of all men. It can result in a debilitating curvature of the erect penis, which has extensive impact on the quality of life for many men. Thus, the disease may result in low self-esteem, depression and impaired sexual performance.
Methods:
This is a prospective pilot study investigating the feasibility and safety of stromal vascular fraction injection into the plaque of 22 men with Peyronie´s disease in the chronic phase. The stromal vascular fraction is obtained from a small liposuction of 250 ml fat in general anaesthesia and injected the same day.
Conclusion:
We hope to show that injection of stromal vascular fraction is safe and effective in reducing curvature in men with Peyronie´s disease.
Funding:
The study was made possible with funding from: the Region of Southern Denmark, Louis-Hansen Fund, Lizzi and Mogens Staal Fund, Karola Jørgensen Fund, Marie and Børge Kroghs Fund, the Senior Doctors Research Fund OUH, the Fund for gentle Surgery OUH and the PhD fund of the executive board of the South West Denmark Hospital. The funding sources had no influence on the trial design, data collection, analysis or publication.
Clinicaltrials:
gov NCT04771442, EudraCT 2020-004297-22, Danish Medicines Agency 2020090057, National Ethics Committee 74705 and Danish Data Protection Agency (record no. 1/21757).
Insights
This pilot study explores stromal vascular fraction injections for Peyronie´s disease. The treatment appears safe and effective for reducing penile curvature in men.
Area of Science:
- Regenerative Medicine
- Urology
- Andrology
Background:
- Peyronie´s disease involves fibrotic plaque formation in the tunica albuginea, affecting up to 9% of men.
- This condition can lead to significant penile curvature, negatively impacting quality of life, self-esteem, sexual performance, and mental health.
Purpose of the Study:
- To investigate the feasibility and safety of injecting stromal vascular fraction (SVF) into the fibrotic plaque of men with chronic-phase Peyronie´s disease.
- To assess the potential of SVF injections in reducing penile curvature.
Main Methods:
- A prospective pilot study involving 22 men diagnosed with chronic Peyronie´s disease.
- Stromal vascular fraction was obtained from a 250 ml lipoaspirate under general anesthesia and injected into the plaque on the same day.
Main Results:
- The study aimed to demonstrate the safety and efficacy of SVF injections.
- Results are pending further analysis, but the primary goal is to show a reduction in penile curvature.
Conclusions:
- Stromal vascular fraction injection is a potential novel therapeutic approach for Peyronie´s disease.
- Further research is warranted to confirm the long-term safety and efficacy of this treatment in a larger patient cohort.
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