Urinary IncontinencePRPIUNCT07832487
Strategy for Managing Urinary Incontinence With PRP
A study testing Plasma rich platelet injection, Blood test and cytobacteriological examination of urine in people with Urinary Incontinence and Platelet Rich Plasma, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Urinary Incontinence, Platelet Rich Plasma
- What is being tested?
- Plasma rich platelet injection, Blood test and cytobacteriological examination of urine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteFrance
- Study dates
- 30 Oct 2026to 30 Oct 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Marie-Hélène Barba contact
France1 site
Hôpital privé Dijon Bourgogne
Dijon, 21100
Aurélie Guyomard, Dr, 06 76 38 29 90 ext. 0033, docteurguyomard@gmail.com
About this study
Official title: Study of the Strategy for Managing Urinary Incontinence With PRP
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.
Read more
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.
- Conditions
- Urinary Incontinence, Platelet Rich Plasma
- Being tested
- Plasma rich platelet injection, Blood test, cytobacteriological examination of urine, Questionnaire and Physical Exam
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma rich platelet injectionBiological
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 testBiological
10 mL of blood is required to subsequently use the REGEN tube.
cytobacteriological examination of urineBiological
Urine culture to be performed before each PRP injection.
Questionnaire and Physical ExamOther
- 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
| Study group | Role | What they receive |
|---|---|---|
| Urinary incontinence | Experimental | Not described Receives: Biological: Plasma rich platelet injection; Biological: Blood test; Biological: cytobacteriological examination of urine; Other: Questionnaire and Physical Exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start30 Oct 2026 (estimated)
- Primary completion30 Oct 2029 (estimated)
- Study completion30 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la Recherche
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07832487
- Sponsor's protocol ID
- 2025-A00430-49
- Acronym
- PRPIU
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Strategy for Managing Urinary Incontinence With PRP
- ClinicalTrials.gov ID
- NCT07832487
- Acronym / sponsor ID
- PRPIU / 2025-A00430-49
- Conditions
- Urinary Incontinence, Platelet Rich Plasma
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 30 Oct 2026 (estimated)
- Primary completion
- 30 Oct 2029 (estimated)
- Study completion
- 30 Oct 2029 (estimated)
- First posted
- 22 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Urinary incontinence | Experimental | Biological: Plasma rich platelet injection, Biological: Blood test, Biological: cytobacteriological examination of urine, Other: Questionnaire and Physical Exam |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plasma rich platelet injectionPRP 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. | Biological | Urinary incontinence |
| Blood test10 mL of blood is required to subsequently use the REGEN tube. | Biological | Urinary incontinence |
| cytobacteriological examination of urineUrine culture to be performed before each PRP injection. | Biological | Urinary incontinence |
| 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 | Other | Urinary incontinence |
Primary outcome
Achievement of the Clinically Important Difference (CID) in the ICIQ-UI-SF (International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form) score
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marie-Hélène Barba contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plasma rich platelet injection, Blood test and cytobacteriological examination of urine in people with Urinary Incontinence and Platelet Rich Plasma, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean-François Oudet (0033683346567, jf.oudet@ecten.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Achievement of the Clinically Important Difference (CID) in the ICIQ-UI-SF (International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form) score (time frame: three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.