Study of the Strategy for Managing Urinary Incontinence With PRP
| Registry | NCT07832487, acronym PRPIU |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, treatment |
| Enrollment | 41 (Estimated) |
| Sponsor | GCS Ramsay Santé pour l'Enseignement et la Recherche (Other) |
| Conditions | Urinary Incontinence, Platelet Rich Plasma |
| Interventions | Plasma rich platelet injection, Blood test, cytobacteriological examination of urine, Questionnaire and Physical Exam (Biological, other) |
| Dates | start 2026-10-30 (estimated), primary completion 2029-10-30 (estimated), completion 2029-10-30 (estimated), first posted 2026-09-22, last updated 2026-09-22 |
| Locations | 1 site in France |
Related Papers Related Patents Related Grants Related Experts
All trials for Urinary Incontinence All trials for Platelet Rich Plasma All trials of Plasma rich platelet injection All trials of Blood test
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Urinary incontinence | Experimental | Biological: Plasma rich platelet injection; Biological: Blood test; Biological: cytobacteriological examination of urine; Other: Questionnaire and Physical Exam |
Sex: Female, ages: 18 Years to 80 Years
Inclusion Criteria: * Female patient aged 18 to under 80 years, * Diagnosis of pure or mixed stress urinary incontinence due to urethral hypermobility or sphincter insufficiency, * ICIQ score greater than or equal to 7, * USP score > 2 and < 7, * Failure of pelvic floor rehabilitation and desire for treatment, * Patient affiliated with or a beneficiary of a social security scheme, in accordance with Article L.1124-1 of the Public Health Code, * Free, informed, and signed consent. Exclusion Criteria: * Patient with no prior pelvic floor rehabilitation, * Positive urine culture (ECBU) prior to the procedure, * Dysuria (assessed via the USP questionnaire and uroflowmetry: pre-intervention post-void residual volume measurement), * Use of anticoagulants within the 7 days preceding the scheduled procedure, * Patient suffering from cancer or a hematological disorder, * Adult under guardianship, curatorship, or other legal protection; deprived of liberty by judicial or administrative decision; or hospitalized without consent, * Pregnant, breastfeeding, or recently delivered woman, * Patient planning a pregnancy during the study period.
| Facility | City | Country | Status |
|---|---|---|---|
| Hôpital privé Dijon Bourgogne | Dijon | France |