Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2017-06-29
2018-10-03
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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PRP Treatment
Women with SUI received PRP injection into anterior vaginal wall (near external urethral sphincter) once per month for three times.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Age between 20 to 85 years
Exclusion Criteria
* Under NSAIDs
* Platelet dysfunction syndrome
* Critical thrombocytopenia
* Hypofibrionogenaemia
* Sepsis
* Acute and chronic infections
* Chronic liver disease
* Anti-coagulation therapy
* History of malignancy
* Pregnancy
20 Years
85 Years
FEMALE
No
Sponsors
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Kaohsiung Medical University Chung-Ho Memorial Hospital
OTHER
Responsible Party
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Principal Investigators
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Cheng-Yu Long, PhD
Role: PRINCIPAL_INVESTIGATOR
Kaohsiung Municipal University Chung-Ho Memorial Hospital
Locations
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Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
Countries
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References
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Billecocq S, Bo K, Dumoulin C, Aigon A, Amarenco G, Bakker E, Cornillet-Bernard M, Cretinon S, Deffieux X, Lartigues G, Loobuick M, Steenstrup B, de Tayrac R. [An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for the conservative and non-pharmacological management of female pelvic floor dysfunction]. Prog Urol. 2019 Mar;29(4):183-208. doi: 10.1016/j.purol.2018.12.010. Epub 2019 Feb 23. French.
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 floor dysfunction. Int Urogynecol J. 2010 Jan;21(1):5-26. doi: 10.1007/s00192-009-0976-9. Epub 2009 Nov 25.
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.300.11.1311.
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. doi: 10.1016/S0029-7844(97)00058-6.
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.
Chrysanthopoulou EL, Pergialiotis V, Perrea D, Kappaourkoulis 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.
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.
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 Mar 2.
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 Reconstr Surg. 2015 Jul-Aug;21(4):190-7. doi: 10.1097/SPV.0000000000000178.
Other Identifiers
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KMUHIRB-F(I)-20170048
Identifier Type: -
Identifier Source: org_study_id
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