Strategy for Managing Urinary Incontinence With PRP
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-80
SponsorGCS Ramsay Santé pour l'Enseignement et la Recherche
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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,
Disqualifiers
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,
Trial design
Design model
Single group
Treatments tested in this trial
Plasma rich platelet injection
Biological/VaccinePRP 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
Biological/Vaccine10 mL of blood is required to subsequently use the REGEN tube.
cytobacteriological examination of urine
Biological/VaccineUrine culture to be performed before each PRP injection.
Questionnaire and Physical Exam
Other intervention* 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
Treatment groups
41 Participants
are divided into 1 treatment groupGroup A: Urinary incontinenceExperimental treatment 4 interventions
Trial outcomes
Primary outcomes
1
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 monthsSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: