Platelet-rich Plasma for Stress Urinary Incontinence

Stress urinary incontinence (SUI) is defined by the International Continence Society (ICS) as "the complaint of any involuntary loss of urine on effort or physical exertion or on sneezing or coughing. The treatment varies from Kegel exercise, bulking agents, vaginal LASER, to surgery. Platelet-rich plasma (PRP) stimulates angiogenesis, promoting vascular in-growth and fibroblast proliferation, enhancing wound-healing in both soft and hard tissue. PRP regulates tissue reconstruction and has been previously used in orthopedics and plastic surgery. The previous study revealed some promising results for PRP use in pelvic floor dysfunction, including SUI. We aim to evaluate the effect of PRP on female SUI.

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Key information

Conditions

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

Age range

20 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807, Taiwan

About this study

Women with SUI were enrolled. Pre-treatment evaluation included Overactive Bladder Symptom Score (OABSS), International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI), Pelvic Organ Prolapse Distress Inventory 6 (POPDI-6), Female Sexual Function Index (FSFI), Urinary Distress Inventory Short Form (UDI-6), Incontinence Impact Questionnaire, Short Form (IIQ-7), pelvic examination, and urodynamic study (UDS) (including pad test).

10 milliliter blood was taken from each participant. The RegenKit-THT (RegenLab SA, Switzerland) was used to separation of plasma and blood cells. 3 milliliter PRP was extracted from the bottom of the plasma. PRP was injected into anterior vaginal wall, near external urethral sphincter, and into endopelvic fascia. The participants received one treatment per month for three times. Follow-up schedule is as below: 1st month (transperineal ultrasound and questionnaires), 3rd month (UDS and questionnaires), 6th month (questionnaires), and 12th month (questionnaires).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Women with SUI
Age between 20 to 85 years

Exclusion criteria

Under anti-platelet agent treatment
Under NSAIDs
Platelet dysfunction syndrome
Critical thrombocytopenia
Hypofibrionogenaemia
Sepsis
Acute and chronic infections
Chronic liver disease
Anti-coagulation therapy
History of malignancy
Pregnancy

Treatment and study plan

Platelet-rich plasma

Device

The RegenKit-THT (RegenLab SA, Switzerland) was used to separation of plasma and blood cells. 3mL PRP was extracted from the bottom of the plasma. PRP was injected into anterior vaginal wall, near external urethral sphincter, and into endopelvic fascia.

Primary outcomes

SUI

Time frame: 3 months

The severity of stress urinary incontinence was measured by pad test.

Sponsors and collaborators

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Other

Registry information

Official study title

The Effect of Platelet-rich Plasma on the Female Stress Urinary Incontinence

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2018
First posted: Feb 21, 2020
Registry last updated: Feb 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed