Clinical trial NCT05112718: Platelet Rich Plasma in Women With Urinary Incontinence
Official title: The Use of Platelet Rich Plasma (PRP) as a Treatment of the Female Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Urinary Incontinence
Stress Urinary Incontinence
Keywords: incontinence
urinary incontinence
stress urinary incontinence
platelet rich plasma
PRP,
outpatient treatment
nonsurgical treatment
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
First posted: 2021-11-09
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Stress urinary incontinence (SUI) is defined as involuntary loss of urine on effort or physical exertion or on sneezing or coughing. Platelet-rich plasma (PRP) is an autologous solution of human plasma containing various growth factors witch enhance regeneration and healing process. The aim of this study is to evaluate the efficacy and safety of PRP in the treatment of the female SUI.


Eligibility criteria: Inclusion Criteria:

* Adult women with stress urinary incontinence

Exclusion Criteria:

* pregnancy,
* history of active malignant pathology,
* mental disorders making them unable to give consent,
* undiagnosed abnormal uterine bleeding,
* genitourinary fistula,
* anti-incontinence surgery,
* pelvic organ prolapse stage \> 2 according to POP-Q system

Primary outcomes:
measure: Stress urinary incontinence symptoms
timeFrame: 6-12 months
Secondary outcomes:
measure: Impact of urinary incontinence on the quality of life
timeFrame: 6-12 months
measure: Assessment of urine loss (1-hr pad test)
timeFrame: 6-12 months
measure: Level of discomfort during injections (VAS score)
timeFrame: 6-12 months
measure: Patient Global Impression of Improvement
timeFrame: 6-12 months
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Urogynecological Unit of Alexandra Hospital
Study officials:
affiliation: National and Kapodistrian University of Athens
name: Stavros Athanasiou, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dawood AS, Salem HA. Current clinical applications of platelet-rich plasma in various gynecological disorders: An appraisal of theory and practice. Clin Exp Reprod Med. 2018 Jun;45(2):67-74. doi: 10.5653/cerm.2018.45.2.67. Epub 2018 Jun 29.
citation: Alves R, Grimalt R. A Review of Platelet-Rich Plasma: History, Biology, Mechanism of Action, and Classification. Skin Appendage Disord. 2018 Jan;4(1):18-24. doi: 10.1159/000477353. Epub 2017 Jul 6.
citation: Schreiber Pedersen L, Lose G, Hoybye MT, Elsner S, Waldmann A, Rudnicki M. Prevalence of urinary incontinence among women and analysis of potential risk factors in Germany and Denmark. Acta Obstet Gynecol Scand. 2017 Aug;96(8):939-948. doi: 10.1111/aogs.13149. Epub 2017 May 20.
citation: Behnia-Willison F, Nguyen TTT, Norbury AJ, Mohamadi B, Salvatore S, Lam A. Promising impact of platelet rich plasma and carbon dioxide laser for stress urinary incontinence. Eur J Obstet Gynecol Reprod Biol X. 2019 Oct 22;5:100099. doi: 10.1016/j.eurox.2019.100099. eCollection 2020 Jan.