Platelet Rich Plasma in Women With Urinary Incontinence
NCT ID: NCT05112718
Last Updated: 2021-11-09
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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UNKNOWN
PHASE2/PHASE3
50 participants
INTERVENTIONAL
2021-07-01
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Platelet Rich Plasma
The patients who receive PRP injections
Platelet Rich Plasma Injections
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.
Normal Saline
The patients who receive normal saline
Normal Saline Injections
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.
Interventions
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Platelet Rich Plasma Injections
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.
Normal Saline Injections
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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National and Kapodistrian University of Athens
OTHER
Responsible Party
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Themos Grigoriadis
Associate Professor of Gynecology
Principal Investigators
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Stavros Athanasiou, Professor
Role: PRINCIPAL_INVESTIGATOR
National and Kapodistrian University of Athens
Locations
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Urogynecological Unit of Alexandra Hospital
Athens, , Greece
Countries
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Central Contacts
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Facility Contacts
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Stavros Athanasiou, Prof.
Role: primary
Themos Grigoriadis, As. Prof.
Role: backup
References
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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.
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.
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.
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.
Grigoriadis T, Kalantzis C, Zacharakis D, Kathopoulis N, Prodromidou A, Xadzilia S, Athanasiou S. Platelet-Rich Plasma for the Treatment of Stress Urinary Incontinence-A Randomized Trial. Urogynecology (Phila). 2024 Jan 1;30(1):42-49. doi: 10.1097/SPV.0000000000001378. Epub 2023 Jun 1.
Other Identifiers
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420/20-09-2019
Identifier Type: -
Identifier Source: org_study_id