NCT04279210

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 29, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 3, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 3, 2018

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 16, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 21, 2020

Completed
Last Updated

February 24, 2020

Status Verified

October 1, 2017

Enrollment Period

1.3 years

First QC Date

February 16, 2020

Last Update Submit

February 20, 2020

Conditions

Stress Urinary Incontinence

Keywords

Stress urinary incontinencePlatelet-rich plasma

Outcome Measures

Primary Outcomes (1)

  • SUI

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

    3 months

Study Arms (1)

PRP Treatment

EXPERIMENTAL

Women with SUI received PRP injection into anterior vaginal wall (near external urethral sphincter) once per month for three times.

Device: Platelet-rich plasma

Interventions

Platelet-rich plasmaDEVICE

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.

PRP Treatment

Eligibility Criteria

Age20 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women with SUI
  • Age between 20 to 85 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807, Taiwan

Location

Related Publications (9)

  • 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.

    PMID: 30803873RESULT

  • 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.

    PMID: 19937315RESULT

  • 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.

    PMID: 18799443RESULT

  • 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.

    PMID: 9083302RESULT

  • 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.

    PMID: 19541423RESULT

  • 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.

    PMID: 28673602RESULT

  • 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.

    PMID: 22972395RESULT

  • 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.

    PMID: 27063081RESULT

  • 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.

    PMID: 25900058RESULT

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Cheng-Yu Long, PhD

    Kaohsiung Municipal University Chung-Ho Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2020

First Posted

February 21, 2020

Study Start

June 29, 2017

Primary Completion

October 3, 2018

Study Completion

October 3, 2018

Last Updated

February 24, 2020

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

The datasets generated during and analyzed during the current study are available from the corresponding author on reasonable request.

Locations

TW(1)