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Platelet Rich Plasma in Women With Urinary Incontinence

Primary Purpose

Urinary Incontinence, Stress Urinary Incontinence

Status
Recruiting
Phase
Phase 2
Locations
Greece
Study Type
Interventional
Intervention
Platelet Rich Plasma Injections
Normal Saline Injections
Sponsored by
National and Kapodistrian University of Athens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence focused on measuring incontinence, urinary incontinence, stress urinary incontinence, platelet rich plasma, PRP,, outpatient treatment, nonsurgical treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult women with stress urinary incontinence

Exclusion Criteria:

  • pregnancy,
  • history of active malignant pathology,
  • mental disorders making them unable to give consent,
  • undiagnosed abnormal uterine bleeding,
  • genitourinary fistula,
  • anti-incontinence surgery,
  • pelvic organ prolapse stage > 2 according to POP-Q system

Sites / Locations

  • Urogynecological Unit of Alexandra HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Platelet Rich Plasma

Normal Saline

Arm Description

The patients who receive PRP injections

The patients who receive normal saline

Outcomes

Primary Outcome Measures

Stress urinary incontinence symptoms
International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS) Number of items: 12 Question items: Nocturia,Urgency, Bladder pain, Frequency, Hesitancy, Straining, Intermittency, Urge urinary incontinence, Frequency of urinary incontinence, Stress urinary incontinence, Unexplained urinary incontinence, Nocturnal enuresis Completion time: 4-5 minutes Scoring: 0-16 filling symptoms subscale 0-12 voiding symptoms subscale 0-20 incontinence symptoms subscale 0-48 where all subscale scores are added. Bother scales are not incorporated in the overall score but indicate impact of individual symptoms for the patient Higher scores indicate greater impact of individual symptoms for the patient.

Secondary Outcome Measures

Impact of urinary incontinence on the quality of life
King's Health Questionnaire (KHQ) Description: The KHQ is an assessment of health-related quality of life related to a specific condition. Format: 21 items about urinary tract symptoms yield scores in 9 domains (general health perception, incontinence impact, role limitations, physical limitations, social limitations, personal relationships, emotions, sleep/energy & severity of symptoms). Scoring: Each item is rated using a 4 or 5 points likert scale. Domain scores range from 0 (best) to 100 (worst). There are 2 single-item domains (general health perceptions, and incontinence impact) and the severity of symptoms domain is scored using a scale from 0 (best) to 30 (worst).
Assessment of urine loss (1-hr pad test)
One-hour pad test standardized by International Continence Society (ICS): started by putting one pre-weighted pad, patient drinks 500 ml in <15 min- then sits or rests, patient walks for 30 min, patient performs the following activities: standing up from sitting, coughing vigorously, running on the spot for 1 min, bending to pick up an object from the floor, and washing hands in running water for 1min the total amount of urine leaked is determined by weighing the pad. Interpretation: The upper limit of weight increase for the 1-hr test in continent women is 1.4 grams. A weight gain of less than 1.4 g during 1-hr test could be a result of sweating or vaginal discharge. An increase of 1-10 g is classified as representing mild incontinence, 11-50 g moderate and >50 g severe incontinence.
Level of discomfort during injections (VAS score)
The visual analog scale (VAS) is pain rating scale. Scores are based on self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale-"no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm).
Patient Global Impression of Improvement
The Patient Global Impression of Improvement (PGI-I) is a validated generic tool for assessment of the over-all improvement or deterioration that the patient may experience following the treatment. The PGI-I is a transition scale that is a single question asking the patient to rate their urinary tract condition now, as compared with how it was prior to before beginning treatment on a scale from 1. Very much better to 7. Very much worse. Therefore, lower values correlate with increased satisfaction.

Full Information

First Posted
October 26, 2021
Last Updated
November 8, 2021
Sponsor
National and Kapodistrian University of Athens
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1. Study Identification

Unique Protocol Identification Number
NCT05112718
Brief Title
Platelet Rich Plasma in Women With Urinary Incontinence
Official Title
The Use of Platelet Rich Plasma (PRP) as a Treatment of the Female Stress Urinary Incontinence
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
May 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National and Kapodistrian University of Athens

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
Stress urinary incontinence (SUI) is defined as involuntary loss of urine on effort or physical exertion or on sneezing or coughing. Platelet-rich plasma (PRP) is an autologous solution of human plasma containing various growth factors witch enhance regeneration and healing process. The aim of this study is to evaluate the efficacy and safety of PRP in the treatment of the female SUI.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Stress Urinary Incontinence
Keywords
incontinence, urinary incontinence, stress urinary incontinence, platelet rich plasma, PRP,, outpatient treatment, nonsurgical treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Platelet Rich Plasma
Arm Type
Experimental
Arm Description
The patients who receive PRP injections
Arm Title
Normal Saline
Arm Type
Sham Comparator
Arm Description
The patients who receive normal saline
Intervention Type
Biological
Intervention Name(s)
Platelet Rich Plasma Injections
Intervention Description
PRP injected into 9 sites of the distal anterior one-third of the vagina using a small 30-gauge needle. The injections were performed at 10, 12 and 2 o'clock in 3 different levels of the urethra 1-2 cm apart (distal, mid and proximal). The participants will receive 2 PRP injections at 4-6-week intervals. Xylocaine gel 2% is applied to the distal anterior vaginal wall 20 minutes before injections.
Intervention Type
Other
Intervention Name(s)
Normal Saline Injections
Intervention Description
Normal saline injected into 9 sites of the distal anterior one-third of the vagina using a small 30-gauge needle. The injections were performed at 10, 12 and 2 o'clock in 3 different levels of the urethra 1-2 cm apart (distal, mid and proximal). The participants will receive 2 injections at 4-6-week intervals.
Primary Outcome Measure Information:
Title
Stress urinary incontinence symptoms
Description
International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS) Number of items: 12 Question items: Nocturia,Urgency, Bladder pain, Frequency, Hesitancy, Straining, Intermittency, Urge urinary incontinence, Frequency of urinary incontinence, Stress urinary incontinence, Unexplained urinary incontinence, Nocturnal enuresis Completion time: 4-5 minutes Scoring: 0-16 filling symptoms subscale 0-12 voiding symptoms subscale 0-20 incontinence symptoms subscale 0-48 where all subscale scores are added. Bother scales are not incorporated in the overall score but indicate impact of individual symptoms for the patient Higher scores indicate greater impact of individual symptoms for the patient.
Time Frame
6-12 months
Secondary Outcome Measure Information:
Title
Impact of urinary incontinence on the quality of life
Description
King's Health Questionnaire (KHQ) Description: The KHQ is an assessment of health-related quality of life related to a specific condition. Format: 21 items about urinary tract symptoms yield scores in 9 domains (general health perception, incontinence impact, role limitations, physical limitations, social limitations, personal relationships, emotions, sleep/energy & severity of symptoms). Scoring: Each item is rated using a 4 or 5 points likert scale. Domain scores range from 0 (best) to 100 (worst). There are 2 single-item domains (general health perceptions, and incontinence impact) and the severity of symptoms domain is scored using a scale from 0 (best) to 30 (worst).
Time Frame
6-12 months
Title
Assessment of urine loss (1-hr pad test)
Description
One-hour pad test standardized by International Continence Society (ICS): started by putting one pre-weighted pad, patient drinks 500 ml in <15 min- then sits or rests, patient walks for 30 min, patient performs the following activities: standing up from sitting, coughing vigorously, running on the spot for 1 min, bending to pick up an object from the floor, and washing hands in running water for 1min the total amount of urine leaked is determined by weighing the pad. Interpretation: The upper limit of weight increase for the 1-hr test in continent women is 1.4 grams. A weight gain of less than 1.4 g during 1-hr test could be a result of sweating or vaginal discharge. An increase of 1-10 g is classified as representing mild incontinence, 11-50 g moderate and >50 g severe incontinence.
Time Frame
6-12 months
Title
Level of discomfort during injections (VAS score)
Description
The visual analog scale (VAS) is pain rating scale. Scores are based on self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale-"no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm).
Time Frame
6-12 months
Title
Patient Global Impression of Improvement
Description
The Patient Global Impression of Improvement (PGI-I) is a validated generic tool for assessment of the over-all improvement or deterioration that the patient may experience following the treatment. The PGI-I is a transition scale that is a single question asking the patient to rate their urinary tract condition now, as compared with how it was prior to before beginning treatment on a scale from 1. Very much better to 7. Very much worse. Therefore, lower values correlate with increased satisfaction.
Time Frame
6-12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult women with stress urinary incontinence Exclusion Criteria: pregnancy, history of active malignant pathology, mental disorders making them unable to give consent, undiagnosed abnormal uterine bleeding, genitourinary fistula, anti-incontinence surgery, pelvic organ prolapse stage > 2 according to POP-Q system
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stavros Athanasiou, Professor
Phone
+306944478555
Email
stavros.athanasiou@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stavros Athanasiou, Professor
Organizational Affiliation
National and Kapodistrian University of Athens
Official's Role
Principal Investigator
Facility Information:
Facility Name
Urogynecological Unit of Alexandra Hospital
City
Athens
ZIP/Postal Code
11528
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stavros Athanasiou, Prof.
Phone
+306944478555
Email
stavros.athanasiou@gmail.com
First Name & Middle Initial & Last Name & Degree
Themos Grigoriadis, As. Prof.
Phone
+306948741306
Email
tgregos@yahoo.com
First Name & Middle Initial & Last Name & Degree
Stavros Athanasiou, Prof
First Name & Middle Initial & Last Name & Degree
Themos Grigoriadis, As. Prof
First Name & Middle Initial & Last Name & Degree
Christos Kalantzis, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29984206
Citation
Dawood AS, Salem HA. Current clinical applications of platelet-rich plasma in various gynecological disorders: An appraisal of theory and practice. Clin Exp Reprod Med. 2018 Jun;45(2):67-74. doi: 10.5653/cerm.2018.45.2.67. Epub 2018 Jun 29.
Results Reference
background
PubMed Identifier
29457008
Citation
Alves R, Grimalt R. A Review of Platelet-Rich Plasma: History, Biology, Mechanism of Action, and Classification. Skin Appendage Disord. 2018 Jan;4(1):18-24. doi: 10.1159/000477353. Epub 2017 Jul 6.
Results Reference
background
PubMed Identifier
28401541
Citation
Schreiber Pedersen L, Lose G, Hoybye MT, Elsner S, Waldmann A, Rudnicki M. Prevalence of urinary incontinence among women and analysis of potential risk factors in Germany and Denmark. Acta Obstet Gynecol Scand. 2017 Aug;96(8):939-948. doi: 10.1111/aogs.13149. Epub 2017 May 20.
Results Reference
background
PubMed Identifier
32021973
Citation
Behnia-Willison F, Nguyen TTT, Norbury AJ, Mohamadi B, Salvatore S, Lam A. Promising impact of platelet rich plasma and carbon dioxide laser for stress urinary incontinence. Eur J Obstet Gynecol Reprod Biol X. 2019 Oct 22;5:100099. doi: 10.1016/j.eurox.2019.100099. eCollection 2020 Jan.
Results Reference
background

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Platelet Rich Plasma in Women With Urinary Incontinence

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