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临床试验/NCT07832487
NCT07832487尚未招募不适用

Study of the Strategy for Managing Urinary Incontinence With PRP

GCS Ramsay Santé pour l'Enseignement et la Recherche1 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2026年10月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
41
试验地点
1
主要终点
Achievement of the Clinically Important Difference (CID) in the ICIQ-UI-SF (International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form) score

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

Urinary incontinence

Experimental

干预措施: Blood test (Biological)

Urinary incontinence

Experimental

干预措施: cytobacteriological examination of urine (Biological)

Urinary incontinence

Experimental

干预措施: Questionnaire and Physical Exam (Other)

Urinary incontinence

Experimental

干预措施: Plasma rich platelet injection (Biological)

结局指标

主要结局

Achievement of the Clinically Important Difference (CID) in the ICIQ-UI-SF (International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form) score

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
GCS Ramsay Santé pour l'Enseignement et la Recherche
申办方类型
Other
责任方
Sponsor

研究点 (1)

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