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Strategy for Managing Urinary Incontinence With PRP
Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Summary
Urinary incontinence is a public health issue; in France, approximately 3 million women are affected. Current treatment options-particularly surgical procedures involving the use of prosthetic materials-are being called into question. In 2019, the use of vaginal prostheses for prolapse was banned. The two sub-urethral sling (SUS) techniques are being challenged at medical conferences and within scientific committees, as they can lead to adverse effects and disastrous complications. Patient advocacy groups are emerging (such as "Balance ta Bandelette"), and media reports are proliferating to pressure authorities to withdraw all prosthetic materials from the market. PRP (Platelet-Rich Plasma) is a technique widely used in cosmetology and rheumatology that could also be applied to the treatment of urinary incontinence. It is known to stimulate the body's natural repair mechanisms, thereby improving tissue nutrition. It is also believed to exert a mechanical effect similar to that of slings. Consequently, an injection into the anterior vaginal wall-a relatively painless procedure performed adjacent to the mid-urethra-could initially act as a bulking agent and subsequently promote tissue regeneration, mimicking the effect of a sling in cases of urethral hypermobility, while also strengthening the sphincter in cases of sphincter deficiency. This study therefore aims to evaluate this treatment approach for patients seeking alternatives to slings.
Official title: Study of the Strategy for Managing Urinary Incontinence With PRP
Key Details
Gender
FEMALE
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
41
Start Date
2026-10-30
Completion Date
2029-10-30
Last Updated
2026-09-22
Healthy Volunteers
No
Conditions
Interventions
Plasma rich platelet injection
PRP is derived from autologous blood collected in a tube containing an anticoagulant (sodium citrate) and subjected to a centrifugation protocol. Centrifugation separates the collected blood into distinct fractions: Platelet-Poor Plasma (PPP, representing 5% of the blood) at the top; Platelet- and Fibrinogen-Rich Plasma (PRP, representing 40% of the blood) in the middle; and granulocytes and leukocytes (representing 55% of the blood) at the bottom of the tube. Once harvested from the red blood cell supernatant, the platelet concentrate is activated (using thrombin or calcium chloride) to trigger the release of a maximum amount of mediators-known as the secretome-which can contain up to 800 protein constituents. Sub-urethral PRP injection (mid-urethra) is done by the gynecologist three times in a row at one-month intervals.
Blood test
10 mL of blood is required to subsequently use the REGEN tube.
cytobacteriological examination of urine
Urine culture to be performed before each PRP injection.
Questionnaire and Physical Exam
* EVA pain score * 4-question neuropathic pain questionnaire * International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form * Urinary symptom profile questionnaire * Patient Global Impressions Improvement
Locations (1)
Hôpital privé Dijon Bourgogne
Dijon, France