Urinary Incontinence Clinical Trial
Official title:
Platelet-Rich Plasma Injection for the Treatment of Female Stress Urinary Incontinence: A Randomized Placebo-Controlled Study
Verified date | November 2022 |
Source | University of Iowa |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 50 |
Est. completion date | May 2024 |
Est. primary completion date | May 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 99 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Iowa | Iowa City | Iowa |
Lead Sponsor | Collaborator |
---|---|
Annah J. Vollstedt |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Female Sexual Function Index (FSFI) scores | How sexual function is after the procedure | 6-months | |
Secondary | 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 | |
Secondary | Questionnaire for Urinary Incontinence Diagnosis (QUID) | How severe the urinary leakage is after the procedure | 6-months | |
Secondary | Perception of Monetary Value | How much money the subject would be willing to pay for the procedure | 6-months | |
Secondary | Visual Analog Scale (VAS) for patient pain/discomfort | How painful the procedure itself is | after injection | |
Secondary | Visual Analog Scale (VAS) for procedure difficulty (by provider) | how difficult the procedure is for the patient | after injection |
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