Platelet-rich Plasma for Stress Urinary Incontinence

Not Applicable

Completed

• Conditions: Stress Urinary Incontinence
• Interventions: Device: Platelet-rich plasma

• Registration Number: NCT04279210
• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

Brief Summary

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.

Detailed Description

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).

Study Timeline

• Study Start: 2017-06-29
• Status Verified: 2017-10
• Primary Completion: 2018-10-03
• Study Completion: 2018-10-03
• Study First Submitted: 2020-02-16
• Study First Submitted QC: 2020-02-19
• Last Update Submitted: 2020-02-20
• Study First Posted: 2020-02-21
• Last Update Posted: 2020-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PRP Treatment	Platelet-rich plasma	Women with SUI received PRP injection into anterior vaginal wall (near external urethral sphincter) once per month for three times.

Primary Outcome Measures

Name	Time	Method
SUI	3 months	The severity of stress urinary incontinence was measured by pad test.

Trial Locations

Locations (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan