Peri-Urethral Platelet-Rich Plasma Injections for Postmenopausal Female Stress Urinary Incontinence

N/ANot Yet RecruitingNCT07807982

Benha University70 enrolled

Overview

his prospective interventional study will evaluate the effectiveness and safety of peri-urethral injections of platelet-rich plasma for treating stress urinary incontinence in postmenopausal women. Platelet-rich plasma is prepared from each participant's own blood and contains concentrated platelets and growth factors that may promote tissue repair and regeneration. Approximately 70 postmenopausal women with stress urinary incontinence will receive peri-urethral platelet-rich plasma injections once monthly for four consecutive months. Platelet-rich plasma will be injected into five sites around the urethra. Participants will be followed after treatment to assess improvement in urinary leakage and urinary symptoms, changes in urodynamic measurements, and treatment-related adverse events. The study aims to determine whether repeated peri-urethral platelet-rich plasma injections can provide a safe and effective minimally invasive treatment option for postmenopausal women with stress urinary incontinence.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Stress Urinary Incontinence

Interventions

Autologous platelet-rich plasma will be prepared from 30 to 50 milliliters of peripheral blood using a two-step centrifugation technique. The first centrifugation will be performed at 200 × g for 20 minutes at 20 degrees Celsius, followed by a second centrifugation at 2000 × g for 20 minutes at 20 degrees Celsius. The final 5 milliliters of platelet-rich plasma, with an expected platelet concentration approximately 2.5 to 5 times the baseline platelet concentration, will be used for peri-urethral injection.

Eligibility

Sex: FEMALEMin age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Postmenopausal women aged 45 years or older. * Stress urinary incontinence confirmed by urodynamic study with intrinsic sphincter deficiency. * Persistent stress urinary incontinence requiring pad use despite conservative management. * Patients unfit for surgical intervention and anesthesia. * Coagulation disorders or current anticoagulant therapy that cannot be safely discontinued. * Patients with comorbidities. Exclusion Criteria: * Urinary tract infection. * Neurological disorders affecting lower urinary tract function. * Pelvic organ prolapse greater than stage II according to the Pelvic Organ Prolapse Quantification system. * Previous urethral surgery. * Inability or unwillingness to comply with follow-up visits.

Outcomes

Primary Outcomes

Treatment Success Based on Global Response Assessment Score

Treatment response will be assessed using the Global Response Assessment score, which ranges from -3 to +3. A score of -3 indicates markedly worse symptoms, -2 indicates moderately worse symptoms, -1 indicates mildly worse symptoms, 0 indicates no change, +1 indicates mild improvement, +2 indicates moderate improvement, and +3 indicates marked improvement. Treatment success will be defined as a Global Response Assessment score of +2 or +3. The result will be reported as the number and percentage of participants achieving treatment success.

Time frame: 1 month after the fourth platelet-rich plasma injection

Secondary Outcomes

Dry Rate

Dry rate will be defined as the proportion of participants achieving complete continence without urinary leakage and without the need for pad protection. The number and percentage of participants who are completely dry will be recorded.

Time frame: 1, 3, and 6 months after the fourth platelet-rich plasma injection

Change in Stress Urinary Incontinence Severity Assessed by the Visual Analogue Scale

Stress urinary incontinence severity will be assessed using a 10-point Visual Analogue Scale modified from the Stamey grading system, ranging from 0 to 10, with higher scores indicating more severe urinary incontinence.

Time frame: Baseline through 6 months after the fourth platelet-rich plasma injection

Change in Abdominal Leak Point Pressure

Abdominal leak point pressure will be measured during urodynamic evaluation at full bladder. The change in abdominal leak point pressure from baseline will be assessed, with the measurement reported in centimeters of water.