Platelet-Rich Plasma for Stress Urinary Incontinence

  • STATUS
    Recruiting
  • End date
    May 5, 2024
  • participants needed
    50
  • sponsor
    Annah J. Vollstedt
Updated on 5 June 2022
stress incontinence
Accepts healthy volunteers

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.

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.

Details
Condition Urinary Incontinence,Stress, Urinary Incontinence
Treatment platelet-rich plasma injection
Clinical Study IdentifierNCT05390970
SponsorAnnah J. Vollstedt
Last Modified on5 June 2022

Eligibility

Yes No Not Sure

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
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