Platelet-Rich Plasma for Stress Urinary Incontinence

Sponsor
Annah J. Vollstedt (Other)
Overall Status
Recruiting
CT.gov ID
NCT05390970
Collaborator
(none)
50
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2
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Platelet-rich plasma injection
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Platelet-Rich Plasma Injection for the Treatment of Female Stress Urinary Incontinence: A Randomized Placebo-Controlled Study
Anticipated Study Start Date :
May 23, 2022
Anticipated Primary Completion Date :
May 1, 2024
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Platelet-rich Plasma

These subjects will have the active PRP injected into their anterior vaginal wall.

Procedure: Platelet-rich plasma injection
Injection of autologous platelet-rich plasma into the anterior vaginal wall

Placebo Comparator: Placebo (saline)

These subjects will have a saline placebo injected into the anterior vaginal wall.

Procedure: Platelet-rich plasma injection
Injection of autologous platelet-rich plasma into the anterior vaginal wall

Outcome Measures

Primary Outcome Measures

  1. Negative urinary stress test (no leakage noted on examination during cough or Valsalva maneuvers at a standardized bladder volume of 300 mL [6-months]

    Negative urinary stress test (no leakage noted on examination during cough or Valsalva)

  2. 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) [6-months]

    How improved the patient feels

Secondary Outcome Measures

  1. Female Sexual Function Index (FSFI) scores [6-months]

    How sexual function is after the procedure

  2. Incontinence-Quality of Life (I-QOL) scores [6-months]

    How the subject's quality of life is different related to urinary leakage after the procedure

  3. Questionnaire for Urinary Incontinence Diagnosis (QUID) [6-months]

    How severe the urinary leakage is after the procedure

  4. Perception of Monetary Value [6-months]

    How much money the subject would be willing to pay for the procedure

  5. Visual Analog Scale (VAS) for patient pain/discomfort [after injection]

    How painful the procedure itself is

  6. Visual Analog Scale (VAS) for procedure difficulty (by provider) [after injection]

    how difficult the procedure is for the patient

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Iowa Iowa City Iowa United States 52242

Sponsors and Collaborators

  • Annah J. Vollstedt

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Annah J. Vollstedt, Principle investigator, University of Iowa
ClinicalTrials.gov Identifier:
NCT05390970
Other Study ID Numbers:
  • 202112270
First Posted:
May 25, 2022
Last Update Posted:
May 25, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 25, 2022