Platelet-Rich Plasma for Stress Urinary Incontinence

Phase 3

Completed

Brief 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Placebo (saline)	Platelet-rich plasma injection	These subjects will have a saline placebo injected into the anterior vaginal wall.
Platelet-rich Plasma	Platelet-rich plasma injection	These subjects will have the active PRP injected into their anterior vaginal wall.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Negative Urinary Stress Test (no Leakage Noted on Examination During Cough or Valsalva Maneuvers at a Standardized Bladder Volume of 300 mL)	6-months	Negative urinary stress test (no leakage noted on examination during cough or Valsalva maneuvers at a standardized bladder volume of 300 mL
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)	6-months	Answered "very much better" or "much better" on the Patient Global Impression of Improvement (PGI-I)

Secondary Outcome Measures

Name	Time	Method
Incontinence-Quality of Life (I-QOL) Scores	6-months	How the subject's quality of life is different related to urinary leakage after the procedure based on their I-QOL score. Score ranges from 22-110, the higher the score the better their quality of life. Scale goes from 1 "Extremely' to 5 "Not at all".
Questionnaire for Urinary Incontinence Diagnosis (QUID)	6-months	How severe the urinary leakage is after the procedure based on the QUID score. Score ranges from 0-30. Scale ranges from 0 "None of the time" to 5 "All of the time".
Visual Analog Scale (VAS) for Patient Pain/Discomfort	after injection	How painful the procedure itself is from 0 to 10 with 0 being no pain and 10 being "pain as bad as it could be"
Female Sexual Function Index (FSFI) Scores	6-months	6-months FSFI score in the PRP group versus the saline group. Score range is 0-36, the higher the value the greater the level of sexual functioning. Scale ranges from 0 "No sexual activity", 1 "Almost never or never" to 5 "Almost always or always" OR 0 "No sexual activity", 1 "Extremely difficult or impossible" to 5 "Not difficult".
Perception of Monetary Value	6-months	How much money the subject would be willing to pay for the procedure; this was a free text question
Visual Analog Scale (VAS) for Procedure Difficulty (by Provider)	after injection	how difficult the procedure is for the patient on a scale from 0 to 10 with 0 being not difficult at all and 10 being the most difficult procedure to perform