Platelet Rich Plasma in Women With Urinary Incontinence

Phase 2

• Conditions: Urinary Incontinence; Stress Urinary Incontinence
• Interventions: Other: Normal Saline Injections; Biological: Platelet Rich Plasma Injections

• Registration Number: NCT05112718
• Lead Sponsor: National and Kapodistrian University of Athens

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-01
• Study First Submitted: 2021-10-26
• Status Verified: 2021-11
• Study First Submitted QC: 2021-11-08
• Last Update Submitted: 2021-11-08
• Study First Posted: 2021-11-09
• Last Update Posted: 2021-11-09
• Primary Completion: 2022-05
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal Saline	Normal Saline Injections	The patients who receive normal saline
Platelet Rich Plasma	Platelet Rich Plasma Injections	The patients who receive PRP injections

Primary Outcome Measures

Name	Time	Method
Stress urinary incontinence symptoms	6-12 months	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

Name	Time	Method
Patient Global Impression of Improvement	6-12 months	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.
Assessment of urine loss (1-hr pad test)	6-12 months	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.
Impact of urinary incontinence on the quality of life	6-12 months	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).
Level of discomfort during injections (VAS score)	6-12 months	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).

Trial Locations

Locations (1)

Urogynecological Unit of Alexandra Hospital; 🇬🇷 Athens, Greece