Phase 3
N=50
Platelet-Rich Plasma for Stress Urinary Incontinence
Urinary Incontinence,Stress · Urinary Incontinence
Bottom Line
View on ClinicalTrials.gov: NCT05390970 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: 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) — 15; 16 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Platelet-rich plasma injection (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Annah J. Vollstedt
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
15; 16 | — |
| 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) |
4; 1 | — |
| SECONDARY Female Sexual Function Index (FSFI) Scores |
27; 25 | — |
| SECONDARY Incontinence-Quality of Life (I-QOL) Scores |
87; 88 | — |
| SECONDARY Questionnaire for Urinary Incontinence Diagnosis (QUID) |
10.0; 10.0 | — |
| SECONDARY Perception of Monetary Value |
100; 50 | — |
| SECONDARY Visual Analog Scale (VAS) for Patient Pain/Discomfort |
2.25; 2.87 | — |
| SECONDARY Visual Analog Scale (VAS) for Procedure Difficulty (by Provider) |
2; 2.54 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05390970). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.