Platelet-Rich Plasma for Stress Urinary Incontinence

NCT05390970 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: 202112270
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence,Stress; Urinary Incontinence

Outcome Measures

Primary Outcomes (2)

• Number of Participants With 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 maneuvers at a standardized bladder volume of 300 mL

  6-months

• 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)

  Answered "very much better" or "much better" on the Patient Global Impression of Improvement (PGI-I)

  6-months

Secondary Outcomes (6)

• Female Sexual Function Index (FSFI) Scores

  6-months

• Incontinence-Quality of Life (I-QOL) Scores

  6-months

• Questionnaire for Urinary Incontinence Diagnosis (QUID)

  6-months

• Perception of Monetary Value

  6-months

• Visual Analog Scale (VAS) for Patient Pain/Discomfort

  after injection

Study Arms (2)

Platelet-rich Plasma

EXPERIMENTAL

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

Procedure: Platelet-rich plasma injection

Placebo (saline)

PLACEBO COMPARATOR

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

Procedure: Platelet-rich plasma injection

Interventions

Platelet-rich plasma injection PROCEDURE

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

Placebo (saline); Platelet-rich Plasma

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Annah J. Vollstedt: lead

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress; Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Annah J. Vollstedt
• Organization: University of Iowa Healthcare

annah-vollstedt@uiowa.edu

712-253-1627

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: May 25, 2022
• Study Start: May 23, 2022
• Primary Completion: December 13, 2023
• Study Completion: December 13, 2023
• Last Updated: August 29, 2024
• Results First Posted: August 29, 2024

Record last verified: 2024-08

Locations

US (1)