Platelet-Rich Plasma for Stress Urinary Incontinence

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Urinary Incontinence; Urinary Incontinence,Stress
• Intervention / Treatment: Procedure: Platelet-rich plasma injection

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 97 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Women aged 18 years or older
2. Pure or stress-predominant urinary incontinence with the Medical, Epidemiologic, and Social Aspects of Aging questionnaire (MESA) stress incontinence symptom score greater than MESA urge incontinence symptom score
3. Observation of leakage by provocative stress test at bladder volume £ 300 mL [15]
4. Post void residual < 150 mL

Exclusion Criteria:

1. Currently pregnant or trying to conceive
2. Currently breastfeeding
3. Interstitial cystitis
4. Urgency urinary incontinence predominance or currently being treated for overactive bladder with medication, percutaneous tibial nerve stimulation, bladder chemodenervation, or sacral neuromodulation
5. Currently being treated for a sexually transmitted disease
6. Pelvic organ prolapse greater than stage 2 according to the Pelvic Organ Prolapse Quantification System
7. Periurethral mass
8. Active gynecologic, urologic or colorectal cancer
9. History of pelvic radiation
10. Psychological disorder making the patient unable to provide consent
11. Undiagnosed abnormal uterine bleeding
12. Genitourinary fistula
13. Prior SUI surgery
14. Use of anti-platelet or anti-coagulant medication
15. Regular use of non-steroidal anti-inflammatorie

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Platelet-rich Plasma; These subjects will have the active PRP injected into their anterior vaginal wall.	Procedure: Platelet-rich plasma injection; Injection of autologous platelet-rich plasma into the anterior vaginal wall
Placebo Comparator: Placebo (saline); These subjects will have a saline placebo injected into the anterior vaginal wall.	Procedure: Platelet-rich plasma injection; Injection of autologous platelet-rich plasma into the anterior vaginal wall

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Negative urinary stress test (no leakage noted on examination during cough or Valsalva maneuvers at a standardized bladder volume of 300 mL	Negative urinary stress test (no leakage noted on examination during cough or Valsalva)	6-months
Subjective outcome with improvement in the Patient Global Impression of Improvement (PGI-I), with positive response defined as "very much better" (1) or "much better" (2)	How improved the patient feels	6-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Female Sexual Function Index (FSFI) scores	How sexual function is after the procedure	6-months
Incontinence-Quality of Life (I-QOL) scores	How the subject's quality of life is different related to urinary leakage after the procedure	6-months
Questionnaire for Urinary Incontinence Diagnosis (QUID)	How severe the urinary leakage is after the procedure	6-months
Perception of Monetary Value	How much money the subject would be willing to pay for the procedure	6-months
Visual Analog Scale (VAS) for patient pain/discomfort	How painful the procedure itself is	after injection
Visual Analog Scale (VAS) for procedure difficulty (by provider)	how difficult the procedure is for the patient	after injection

Collaborators and Investigators

• Sponsor: Annah J. Vollstedt

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2022
• Primary Completion (Anticipated): May 1, 2024
• Study Completion (Anticipated): May 1, 2024

Study Registration Dates

• First Submitted: May 12, 2022
• First Submitted That Met QC Criteria: May 22, 2022
• First Posted (Actual): May 25, 2022

Study Record Updates

• Last Update Posted (Actual): November 4, 2022
• Last Update Submitted That Met QC Criteria: November 2, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: 202112270

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No