Urinary Incontinence, Platelet Rich Plasma
Conditions
Brief 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.
Interventions
BIOLOGICALPlasma 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.
BIOLOGICALBlood test
10 mL of blood is required to subsequently use the REGEN tube.
BIOLOGICALcytobacteriological examination of urine
Urine culture to be performed before each PRP injection.
OTHERQuestionnaire 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
Sponsors
GCS Ramsay Santé pour l'Enseignement et la Recherche
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Achievement of the Clinically Important Difference (CID) in the ICIQ-UI-SF (International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form) score | three months | 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. |
Countries
France
Contacts
CONTACTJean-François Oudet
CONTACTMarie-Hélène Barba
Outcome results
None listed