Platelet-Rich Plasma for Stress Urinary Incontinence

NCT ID: NCT05390970

Last Updated: 2024-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-23
• Study Completion Date: 2023-12-13

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.

Conditions

Urinary Incontinence,Stress; Urinary Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Platelet-rich Plasma

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

Group Type: EXPERIMENTAL

Platelet-rich plasma injection

Intervention Type: PROCEDURE

Injection of autologous platelet-rich plasma into the anterior vaginal wall

Placebo (saline)

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

Group Type: PLACEBO_COMPARATOR

Platelet-rich plasma injection

Intervention Type: PROCEDURE

Injection of autologous platelet-rich plasma into the anterior vaginal wall

Interventions

Platelet-rich plasma injection

Injection of autologous platelet-rich plasma into the anterior vaginal wall

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Annah J. Vollstedt

OTHER

Sponsor Role: lead

Responsible Party

Annah J. Vollstedt

Principle investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

University of Iowa

Iowa City, Iowa, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

202112270

Identifier Type: -

Identifier Source: org_study_id