Platelet-Rich Plasma for Stress Urinary Incontinence

Urinary Incontinence Clinical Trial

Official title:

Platelet-Rich Plasma Injection for the Treatment of Female Stress Urinary Incontinence: A Randomized Placebo-Controlled Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05390970
• Other study ID #: 202112270
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 23, 2022
• Est. completion date: May 2024

Study information

• Verified date: November 2022
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence
• Urinary Incontinence, Stress
• Urinary Incontinence,Stress

Intervention

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

Locations

Country	Name	City	State
United States	University of Iowa	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Annah J. Vollstedt

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Negative urinary stress test (no leakage noted on examination during cough or Valsalva maneuvers at a standardized bladder volume of 300 mL	Negative urinary stress test (no leakage noted on examination during cough or Valsalva)	6-months
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)	How improved the patient feels	6-months
Secondary	Female Sexual Function Index (FSFI) scores	How sexual function is after the procedure	6-months
Secondary	Incontinence-Quality of Life (I-QOL) scores	How the subject's quality of life is different related to urinary leakage after the procedure	6-months
Secondary	Questionnaire for Urinary Incontinence Diagnosis (QUID)	How severe the urinary leakage is after the procedure	6-months
Secondary	Perception of Monetary Value	How much money the subject would be willing to pay for the procedure	6-months
Secondary	Visual Analog Scale (VAS) for patient pain/discomfort	How painful the procedure itself is	after injection
Secondary	Visual Analog Scale (VAS) for procedure difficulty (by provider)	how difficult the procedure is for the patient	after injection