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Platelet-rich Plasma for Stress Urinary Incontinence

Primary Purpose

Stress Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Platelet-rich plasma
Sponsored by
Kaohsiung Medical University Chung-Ho Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring Stress urinary incontinence, Platelet-rich plasma

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PRP Treatment

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 16, 2020
Last Updated
February 20, 2020
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04279210
Brief Title
Platelet-rich Plasma for Stress Urinary Incontinence
Official Title
The Effect of Platelet-rich Plasma on the Female Stress Urinary Incontinence
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
June 29, 2017 (Actual)
Primary Completion Date
October 3, 2018 (Actual)
Study Completion Date
October 3, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence
Keywords
Stress urinary incontinence, Platelet-rich plasma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PRP Treatment
Arm Type
Experimental
Arm Description
Women with SUI received PRP injection into anterior vaginal wall (near external urethral sphincter) once per month for three times.
Intervention Type
Device
Intervention Name(s)
Platelet-rich plasma
Intervention Description
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 Outcome Measure Information:
Title
SUI
Description
The severity of stress urinary incontinence was measured by pad test.
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheng-Yu Long, PhD
Organizational Affiliation
Kaohsiung Municipal University Chung-Ho Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The datasets generated during and analyzed during the current study are available from the corresponding author on reasonable request.
Citations:
PubMed Identifier
30803873
Citation
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.
Results Reference
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Citation
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Citation
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Citation
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PubMed Identifier
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Citation
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Citation
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PubMed Identifier
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Citation
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Citation
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Results Reference
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Platelet-rich Plasma for Stress Urinary Incontinence

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