Platelet-Rich Plasma for Stress Urinary Incontinence

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Urinary Incontinence,Stress, Urinary Incontinence

Intervention / Treatment
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* Procedure: Platelet-rich plasma injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women aged 18 years or older 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 Observation of leakage by provocative stress test at bladder volume £ 300 mL [15] Post void residual < 150 mL Exclusion Criteria: Currently pregnant or trying to conceive Currently breastfeeding Interstitial cystitis Urgency urinary incontinence predominance or currently being treated for overactive bladder with medication, percutaneous tibial nerve stimulation, bladder chemodenervation, or sacral neuromodulation Currently being treated for a sexually transmitted disease Pelvic organ prolapse greater than stage 2 according to the Pelvic Organ Prolapse Quantification System Periurethral mass Active gynecologic, urologic or colorectal cancer History of pelvic radiation Psychological disorder making the patient unable to provide consent Undiagnosed abnormal uterine bleeding Genitourinary fistula Prior SUI surgery Use of anti-platelet or anti-coagulant medication Regular use of non-steroidal anti-inflammatorie

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 |