Platelet-Rich Plasma for Stress Urinary Incontinence

Last updated: August 7, 2024
Sponsor: Annah J. Vollstedt
Overall Status: Completed

Phase

3

Condition

Urinary Incontinence

Enuresis

Treatment

Platelet-rich plasma injection

Clinical Study ID

NCT05390970
202112270
  • Ages 18-99
  • Female
  • Accepts Healthy Volunteers

Study 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

Inclusion Criteria:

  1. Women aged 18 years or older

  2. Pure or stress-predominant urinary incontinence with the Medical, Epidemiologic, andSocial Aspects of Aging questionnaire (MESA) stress incontinence symptom scoregreater 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

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 overactivebladder with medication, percutaneous tibial nerve stimulation, bladderchemodenervation, 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 ProlapseQuantification 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

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Platelet-rich plasma injection
Phase: 3
Study Start date:
May 23, 2022
Estimated Completion Date:
December 13, 2023

Study 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.

Connect with a study center

  • University of Iowa

    Iowa City, Iowa 52242
    United States

    Site Not Available

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