NCT05390970

Platelet-Rich Plasma for Stress Urinary Incontinence

Platelet-Rich Plasma Injection for the Treatment of Female Stress Urinary Incontinence: A Randomized Placebo-Controlled Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Annah J. Vollstedt · Academic / Other
• Sex: Female
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

Summary

The aim of this randomized controlled trial study is to evaluate the efficacy and safety of platelet-rich plasma (PRP) in the treatment of female stress urinary incontinence (SUI), compared to placebo. Subjects will undergo an injection of PRP (or injectable saline placebo) into the anterior vaginal wall in the office. Primary outcomes will include a negative urinary stress test plus improvement with the Patient Global Impression of Improvement (PGI-I) at 6-months. Secondary outcomes will include the Female Sexual Function Index (FSFI), the Incontinence Quality of life (I-QOL), Questionnaire for Urinary Incontinence Diagnosis (QUID), and the visual analog scale for pain.

Detailed description

Platelet-rich plasma (PRP) is an autologous solution of human plasma with a high concentration of platelets. While the preparation and injection of PRP is not a new technology, it has not been well-studied in the field of urogynecology. Small case series have suggested PRP may be used in the treatment of stress urinary incontinence (SUI). The aim of this randomized controlled trial study is to evaluate the efficacy and safety of PRP in the treatment of female SUI, compared to placebo. Adult females with SUI or with stress-predominant mixed urinary incontinence will be eligible. Subjects will undergo an injection of PRP (or injectable saline) into the anterior vaginal wall in the office. At baseline and at time points of 1, 3, and 6 months, subjects will complete the validated questionnaires. A pelvic exam with a stress test will be performed by a blinded provider at the 3 and 6-month visits. Primary outcomes will include a negative urinary stress test plus improvement with the Patient Global Impression of Improvement (PGI-I) at 6-months. Secondary outcomes will include the Female Sexual Function Index (FSFI), the Incontinence Quality of life (I-QOL), Questionnaire for Urinary Incontinence Diagnosis (QUID), and the visual analog scale for pain.

Conditions

• Urinary Incontinence,Stress
• Urinary Incontinence

Interventions

Type	Name	Description
PROCEDURE	Platelet-rich plasma injection	Injection of autologous platelet-rich plasma into the anterior vaginal wall

Timeline

• Start date: 2022-05-23
• Primary completion: 2023-12-13
• Completion: 2023-12-13
• First posted: 2022-05-25
• Last updated: 2024-08-29
• Results posted: 2024-08-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study