Platelet-rich Plasma for Stress Urinary Incontinence

Stress Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04279210
• Other study ID #: KMUHIRB-F(I)-20170048
• Status: Completed
• Phase: N/A
• Start date: June 29, 2017
• Est. completion date: October 3, 2018

Study information

• Verified date: October 2017
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 3, 2018
• Est. primary completion date: October 3, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Device:
• Platelet-rich plasma
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.

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (9)

Billecocq S, Bo K, Dumoulin C, Aigon A, Amarenco G, Bakker E, Cornillet-Bernard M, Crétinon S, Deffieux X, Lartigues G, Loobuick M, Steenstrup B, de Tayrac R. [An International Urogynecological Association (IUGA)/International Continence Society (ICS) joi — View Citation

Chrysanthopoulou EL, Pergialiotis V, Perrea D, ?ourkoulis S, Verikokos C, Doumouchtsis SK. Platelet rich plasma as a minimally invasive approach to uterine prolapse. Med Hypotheses. 2017 Jul;104:97-100. doi: 10.1016/j.mehy.2017.05.018. Epub 2017 May 25. — View Citation

Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, Monga A, Petri E, Rizk DE, Sand PK, Schaer GN. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic — View Citation

Medel S, Alarab M, Kufaishi H, Drutz H, Shynlova O. Attachment of Primary Vaginal Fibroblasts to Absorbable and Nonabsorbable Implant Materials Coated With Platelet-Rich Plasma: Potential Application in Pelvic Organ Prolapse Surgery. Female Pelvic Med Rec — View Citation

Nikolopoulos KI, Pergialiotis V, Perrea D, Doumouchtsis SK. Restoration of the pubourethral ligament with platelet rich plasma for the treatment of stress urinary incontinence. Med Hypotheses. 2016 May;90:29-31. doi: 10.1016/j.mehy.2016.02.019. Epub 2016 — View Citation

Nygaard I, Barber MD, Burgio KL, Kenton K, Meikle S, Schaffer J, Spino C, Whitehead WE, Wu J, Brody DJ; Pelvic Floor Disorders Network. Prevalence of symptomatic pelvic floor disorders in US women. JAMA. 2008 Sep 17;300(11):1311-6. doi: 10.1001/jama.300.1 — View Citation

Olsen AL, Smith VJ, Bergstrom JO, Colling JC, Clark AL. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol. 1997 Apr;89(4):501-6. — View Citation

Pallua N, Wolter T, Markowicz M. Platelet-rich plasma in burns. Burns. 2010 Feb;36(1):4-8. doi: 10.1016/j.burns.2009.05.002. Epub 2009 Jun 21. Review. — View Citation

Shirvan MK, Alamdari DH, Mahboub MD, Ghanadi A, Rahimi HR, Seifalian AM. A novel cell therapy for stress urinary incontinence, short-term outcome. Neurourol Urodyn. 2013 Apr;32(4):377-82. doi: 10.1002/nau.22301. Epub 2012 Sep 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SUI	The severity of stress urinary incontinence was measured by pad test.	3 months