search
Back to results

The Efficacy of Injectable Platelet-rich Fibrin in the Treatment of the Female Stress Urinary Incontinence

Primary Purpose

Urinary Incontinence, Treatment

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Local applied injectable platelet-rich fibrin in women with stress urinary incontinence
Sponsored by
Abant Izzet Baysal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence focused on measuring Urinary Stress Incontinence, Platelet-Rich Fibrin, Questionnaire

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: The patient who has pure stress urinary incontinence Exclusion Criteria: The patient who had previous surgery for stress urinary incontinence Known platelet dysfunction Anti-coagulant users Critical thrombocytopenia

Sites / Locations

  • Bolu Abant Izzet Baysal University, Faculty of Medicine

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

The women with stress urinary incontinence administered injectable platelet-rich fibrin

Arm Description

Injectable platelet-rich fibrin was prepared by centrifuging venous blood samples from women with stress urinary incontinence. The obtained autologous material was injected into the anterior vaginal wall, approximately 1.5 cm below the urethral meatus, without applying a local anesthetic. The procedure was repeated for the same patient three times with an interval of one month. The severity of urinary incontinence was evaluated by filling out questionnaires before and after the procedure.

Outcomes

Primary Outcome Measures

Changes in urinary incontinence severity before and 6 months after injectable platelet-rich fibrin application were evaluated with International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF).
ICIQ-SF evaluates the severity of urinary incontinence symptoms and their impact on health-related quality of life. It is scored on a scale from 0-21. A higher score indicates greater impairment from incontinence. Stress urinary incontinence grade according to ICIQ-SF: slight (1-5), moderate (6-12), severe (13-18) and very severe (19-21).

Secondary Outcome Measures

Changes in quality of life in patients with urinary incontinence before and 6 months after injectable platelet-rich fibrin application were evaluated with Urogenital Distress Inventory-6 (UDI-6) and Incontinence Impact Questionnaire-7 (IIQ-7).
UDI-6 is a short version of a condition-specifc quality of life instrument. Higher scores in UDI-6 indicate higher disability. Total score is from 0 to 100. IIQ-7 is a urinary incontinence-specific psychometric questionnaire. This questionnaire assesses the psychosocial impact of UI in women. Higher scores in UDI-6 indicate higher disability. Total score ranges from 0 to 100.

Full Information

First Posted
October 25, 2022
Last Updated
November 10, 2022
Sponsor
Abant Izzet Baysal University
search

1. Study Identification

Unique Protocol Identification Number
NCT05617417
Brief Title
The Efficacy of Injectable Platelet-rich Fibrin in the Treatment of the Female Stress Urinary Incontinence
Official Title
Evaluation of the Efficacy of Locally Administered Autologous Injectable Platelet-rich Fibrin in Women With Stress Urinary Incontinence
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
May 5, 2021 (Actual)
Primary Completion Date
August 26, 2021 (Actual)
Study Completion Date
September 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Abant Izzet Baysal University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
We aimed to evaluate the efficacy of locally applied injectable platelet-rich fibrin in women with stress urinary incontinence. We searched whether there was a decrease in the severity of urinary incontinence after the injection of platelet-rich fibrin. The participants will answer questionnaires about urinary incontinence before and after the injectable platelet-rich fibrin treatment.
Detailed Description
Female patients with pure stress urinary incontinence who gave written informed consent after being informed about the study were included in the study. Two tubes of venous blood samples taken from the patients were centrifuged and injectable platelet-rich fibrin was prepared. The obtained autologous material was injected into the patient within one minute after preparation, without applying a local anesthetic. The injection was given to the anterior wall of the vagina, approximately 1.5 cm below the urethral meatus, coinciding with the mid-urethral region, and the dose was applied to three adjacent points. The procedure was repeated three times at one-month intervals. Before and after the procedure, ICIQ-SF, UDI-6, and IIQ-7 questionnaires were filled and the severity of urinary incontinence was recorded.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Treatment
Keywords
Urinary Stress Incontinence, Platelet-Rich Fibrin, Questionnaire

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Thirty patients with pure stress urinary incontinence were included in the study. Autologously prepared injectable platelet-rich fibrin from the patients was applied locally. The procedure was repeated for the same patient three times with an interval of one month. The severity of urinary incontinence was evaluated and recorded by filling out questionnaires before and after the procedure.
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The women with stress urinary incontinence administered injectable platelet-rich fibrin
Arm Type
Other
Arm Description
Injectable platelet-rich fibrin was prepared by centrifuging venous blood samples from women with stress urinary incontinence. The obtained autologous material was injected into the anterior vaginal wall, approximately 1.5 cm below the urethral meatus, without applying a local anesthetic. The procedure was repeated for the same patient three times with an interval of one month. The severity of urinary incontinence was evaluated by filling out questionnaires before and after the procedure.
Intervention Type
Other
Intervention Name(s)
Local applied injectable platelet-rich fibrin in women with stress urinary incontinence
Intervention Description
Injectable platelet-rich fibrin was prepared by centrifuging venous blood taken from women with stress urinary incontinence and applied locally to the anterior vaginal wall of the patients.
Primary Outcome Measure Information:
Title
Changes in urinary incontinence severity before and 6 months after injectable platelet-rich fibrin application were evaluated with International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF).
Description
ICIQ-SF evaluates the severity of urinary incontinence symptoms and their impact on health-related quality of life. It is scored on a scale from 0-21. A higher score indicates greater impairment from incontinence. Stress urinary incontinence grade according to ICIQ-SF: slight (1-5), moderate (6-12), severe (13-18) and very severe (19-21).
Time Frame
Change in urinary incontinence severity before and 6 months after treatment
Secondary Outcome Measure Information:
Title
Changes in quality of life in patients with urinary incontinence before and 6 months after injectable platelet-rich fibrin application were evaluated with Urogenital Distress Inventory-6 (UDI-6) and Incontinence Impact Questionnaire-7 (IIQ-7).
Description
UDI-6 is a short version of a condition-specifc quality of life instrument. Higher scores in UDI-6 indicate higher disability. Total score is from 0 to 100. IIQ-7 is a urinary incontinence-specific psychometric questionnaire. This questionnaire assesses the psychosocial impact of UI in women. Higher scores in UDI-6 indicate higher disability. Total score ranges from 0 to 100.
Time Frame
Change in urinary incontinence severity before and 6 months after treatment

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The patient who has pure stress urinary incontinence Exclusion Criteria: The patient who had previous surgery for stress urinary incontinence Known platelet dysfunction Anti-coagulant users Critical thrombocytopenia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ülkü Mete Ural
Organizational Affiliation
Bolu Abant Izzet Baysal University, Faculty of Medicine, Department of Obstetrics and Gynecology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bolu Abant Izzet Baysal University, Faculty of Medicine
City
Bolu
State/Province
Gölköy
ZIP/Postal Code
14030
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

The Efficacy of Injectable Platelet-rich Fibrin in the Treatment of the Female Stress Urinary Incontinence

We'll reach out to this number within 24 hrs