Platelet Rich Plasma in Women With Urinary Incontinence

Urinary Incontinence Clinical Trial

Official title:

The Use of Platelet Rich Plasma (PRP) as a Treatment of the Female Stress Urinary Incontinence

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05112718
• Other study ID #: 420/20-09-2019
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: July 1, 2021
• Est. completion date: December 2022

Study information

• Verified date: November 2021
• Source: National and Kapodistrian University of Athens
• Contact: Stavros Athanasiou, Professor
• Phone: +306944478555
• Email: stavros.athanasiou[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2022
• Est. primary completion date: May 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Biological:
• 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.

Other:
• 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.

Locations

Country	Name	City	State
Greece	Urogynecological Unit of Alexandra Hospital	Athens

Sponsors (1)

Lead Sponsor	Collaborator
National and Kapodistrian University of Athens

Country where clinical trial is conducted

Greece, 

References & Publications (4)

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. Review. — View 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. — View 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. Review. — View Citation

Schreiber Pedersen L, Lose G, Høybye 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).	6-12 months
Secondary	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.	6-12 months
Secondary	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).	6-12 months
Secondary	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.	6-12 months