Platelet Rich Plasma in Women With Urinary Incontinence

Sponsor

National and Kapodistrian University of Athens (Other)

Overall Status

Recruiting

CT.gov ID

NCT05112718

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Incontinence Stress Urinary Incontinence	Biological: Platelet Rich Plasma Injections Other: Normal Saline Injections	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 1, 2021

Anticipated Primary Completion Date :

May 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Platelet Rich Plasma The patients who receive PRP injections	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.
Sham Comparator: Normal Saline The patients who receive normal saline	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.

Arm

Intervention/Treatment

Experimental: Platelet Rich Plasma

The patients who receive PRP injections

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.

Sham Comparator: Normal Saline

The patients who receive normal saline

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.

Outcome Measures

Primary Outcome Measures

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

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).
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.
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).
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.