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Platelet-Rich Plasma for Stress Urinary Incontinence

NCT05390970 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-08-29

Study results available
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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

Interventions

PROCEDURE

Platelet-rich plasma injection

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

Sponsors & Collaborators

  • Annah J. Vollstedt

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-23
Primary Completion
2023-12-13
Completion
2023-12-13
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05390970 on ClinicalTrials.gov