Clinical trial NCT05390970: Platelet-Rich Plasma for Stress Urinary Incontinence
Official title: Platelet-Rich Plasma Injection for the Treatment of Female Stress Urinary Incontinence: A Randomized Placebo-Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Urinary Incontinence,Stress
Urinary Incontinence
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2022-05-25
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: 6-months
measure: 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)
timeFrame: 6-months
Secondary outcomes:
measure: Female Sexual Function Index (FSFI) Scores
timeFrame: 6-months
measure: Incontinence-Quality of Life (I-QOL) Scores
timeFrame: 6-months
measure: Questionnaire for Urinary Incontinence Diagnosis (QUID)
timeFrame: 6-months
measure: Perception of Monetary Value
timeFrame: 6-months
measure: Visual Analog Scale (VAS) for Patient Pain/Discomfort
timeFrame: after injection
measure: Visual Analog Scale (VAS) for Procedure Difficulty (by Provider)
timeFrame: after injection
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
References: