Platelet Rich Plasma in Women With Urinary Incontinence

National and Kapodistrian University of Athens

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Stress Urinary Incontinence; Urinary Incontinence

Treatments: Other: Normal Saline Injections; Biological: Platelet Rich Plasma Injections

Study type: Interventional

Funder types: Other

Identifiers

NCT05112718

420/20-09-2019

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Platelet Rich Plasma

Experimental group

Description:

The patients who receive PRP injections

Treatment:

Biological: Platelet Rich Plasma Injections

Normal Saline

Sham Comparator group

Description:

The patients who receive normal saline

Treatment:

Other: Normal Saline Injections