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Platelet Rich Plasma in Women With Urinary Incontinence

NCT05112718 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2021-11-09

No results posted yet for this study

Summary

Stress urinary incontinence (SUI) is defined as involuntary loss of urine on effort or physical exertion or on sneezing or coughing. Platelet-rich plasma (PRP) is an autologous solution of human plasma containing various growth factors witch enhance regeneration and healing process. The aim of this study is to evaluate the efficacy and safety of PRP in the treatment of the female SUI.

Conditions

Interventions

BIOLOGICAL

Platelet Rich Plasma Injections

PRP injected into 9 sites of the distal anterior one-third of the vagina using a small 30-gauge needle. The injections were performed at 10, 12 and 2 o'clock in 3 different levels of the urethra 1-2 cm apart (distal, mid and proximal). The participants will receive 2 PRP injections at 4-6-week intervals. Xylocaine gel 2% is applied to the distal anterior vaginal wall 20 minutes before injections.

OTHER

Normal Saline Injections

Normal saline injected into 9 sites of the distal anterior one-third of the vagina using a small 30-gauge needle. The injections were performed at 10, 12 and 2 o'clock in 3 different levels of the urethra 1-2 cm apart (distal, mid and proximal). The participants will receive 2 injections at 4-6-week intervals.

Sponsors & Collaborators

  • National and Kapodistrian University of Athens

    lead OTHER

Principal Investigators

  • Stavros Athanasiou, Professor · National and Kapodistrian University of Athens

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2022-05-31
Completion
2022-12-31

Countries

  • Greece

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 NCT05112718 on ClinicalTrials.gov