An interventional study of Plasma rich platelet injection and Blood test in Urinary Incontinence and Platelet Rich Plasma, sponsored by GCS Ramsay Santé pour l'Enseignement et la Recherche. Not yet recruiting at 1 site in France. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by GCS Ramsay Santé pour l'Enseignement et la Recherche · Not applicable, Interventional, and Treatment
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.
983 studies on the registry are indexed under Urinary Incontinence; 180 are open to participants now.
This study's planned enrollment of 41 is below the median of 66 across 739 interventional studies indexed under Urinary Incontinence.
Browse Urinary Incontinence studies →GCS Ramsay Santé pour l'Enseignement et la Recherche is the lead sponsor of 207 studies on the registry; 99 are open to participants now.
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Exclusion Criteria:
Biological: Plasma rich platelet injection · Biological: Blood test · Biological: cytobacteriological examination of urine · Other: Questionnaire and Physical Exam
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.
10 mL of blood is required to subsequently use the REGEN tube.
Urine culture to be performed before each PRP injection.
* 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
Achievement of the Clinically Important Difference (CID) in the ICIQ-UI-SF (International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form) score
Achievement of the Clinically Important Difference (CID) in the ICIQ-UI-SF score 12 months after a protocol of three monthly vaginal injections. The questionnaire consists of 4 items : * Frequency or urinary incontinence * Amount of leakage * Overall impact of urinary incontinence * Self-diagnostic item The combined score ranges from 0 to 21, and a higher score means a greater reported symptom burden and a bigger impact on daily life. Score the self-diagnostic item separately, it doesn't get added to the total.
Time frame: three months
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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