NCT05112718

Platelet Rich Plasma in Women With Urinary Incontinence

The Use of Platelet Rich Plasma (PRP) as a Treatment of the Female Stress Urinary Incontinence

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: National and Kapodistrian University of Athens · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urinary Incontinence
• Stress Urinary Incontinence

Interventions

Type	Name	Description
BIOLOGICAL	Platelet Rich Plasma Injections	PRP injected into 9 sites of the distal anterior one-third of the vagina using a small 30-gauge needle. The injections were performed at 10, 12 and 2 o'clock in 3 different levels of the urethra 1-2 cm apart (distal, mid and proximal). The participants will receive 2 PRP injections at 4-6-week intervals. Xylocaine gel 2% is applied to the distal anterior vaginal wall 20 minutes before injections.
OTHER	Normal Saline Injections	Normal saline injected into 9 sites of the distal anterior one-third of the vagina using a small 30-gauge needle. The injections were performed at 10, 12 and 2 o'clock in 3 different levels of the urethra 1-2 cm apart (distal, mid and proximal). The participants will receive 2 injections at 4-6-week intervals.

Timeline

• Start date: 2021-07-01
• Primary completion: 2022-05-01
• Completion: 2022-12-01
• First posted: 2021-11-09
• Last updated: 2021-11-09

Locations

1 site across 1 country: Greece