Platelet Rich Plasma in Women With Urinary Incontinence

NCT05112718 | Unknown Phase 2

• 1 other identifier: 420/20-09-2019
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence; Stress Urinary Incontinence

Keywords

incontinence; urinary incontinence; stress urinary incontinence; platelet rich plasma; PRP,; outpatient treatment; nonsurgical treatment

Outcome Measures

Primary Outcomes (1)

• 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.

  6-12 months

Secondary Outcomes (4)

• Impact of urinary incontinence on the quality of life

  6-12 months

• Assessment of urine loss (1-hr pad test)

  6-12 months

• Level of discomfort during injections (VAS score)

  6-12 months

• Patient Global Impression of Improvement

  6-12 months

Study Arms (2)

Platelet Rich Plasma

EXPERIMENTAL

The patients who receive PRP injections

Biological: Platelet Rich Plasma Injections

Normal Saline

SHAM COMPARATOR

The patients who receive normal saline

Other: Normal Saline Injections

Interventions

Platelet Rich Plasma Injections BIOLOGICAL

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.

Platelet Rich Plasma

Normal Saline Injections OTHER

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.

Normal Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult women with stress urinary incontinence

You may not qualify if:

• 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

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead

Study Sites (1)

Urogynecological Unit of Alexandra Hospital

Athens, 11528, Greece

RECRUITING

Related Publications (5)

• 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.

  PMID: 29984206 BACKGROUND

• 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.

  PMID: 29457008 BACKGROUND

• 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.

  PMID: 28401541 BACKGROUND

• 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.

  PMID: 32021973 BACKGROUND

• 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.

  PMID: 37493287 DERIVED

MeSH Terms

Conditions

Urinary Incontinence; Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Stavros Athanasiou, Professor

  National and Kapodistrian University of Athens

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stavros Athanasiou, Professor

CONTACT

+306944478555; stavros.athanasiou@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Gynecology

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: November 9, 2021
• Study Start: July 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: December 1, 2022
• Last Updated: November 9, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)