Platelet-Rich Plasma Injection for the Treatment of Female Stress Urinary Incontinence: A Randomized Placebo-Controlled Study
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- 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)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Placebo (saline)
These subjects will have a saline placebo injected into the anterior vaginal wall.
Intervention: Platelet-rich plasma injection (Procedure)
Platelet-rich Plasma
These subjects will have the active PRP injected into their anterior vaginal wall.
Intervention: Platelet-rich plasma injection (Procedure)
Outcomes
Primary Outcomes
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)
Time Frame: 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)
Time Frame: 6-months
Answered "very much better" or "much better" on the Patient Global Impression of Improvement (PGI-I)
Secondary Outcomes
- Incontinence-Quality of Life (I-QOL) Scores(6-months)
- Questionnaire for Urinary Incontinence Diagnosis (QUID)(6-months)
- Visual Analog Scale (VAS) for Patient Pain/Discomfort(after injection)
- Female Sexual Function Index (FSFI) Scores(6-months)
- Perception of Monetary Value(6-months)
- Visual Analog Scale (VAS) for Procedure Difficulty (by Provider)(after injection)
Investigators
Annah J. Vollstedt
Principle investigator
University of Iowa