The goal of this clinical trial is to evaluate whether a treated umbilical vein allograft is effective in treating stress urinary incontinence in females. The researchers will compare the treated umbilical vein allograft with a sling made of autologous tissue. The main question the clinical trial aims to answer is:
\- Is the treated umbilical vein allograft as effective as the sling made of autologous tissue for treating female stress urinary incontinence?
Participants will:
* Undergo surgical treatment with either the umbilical vein allograft or the sling made of autologous tissue on Day 0. * Visit the hospital for a series of tests at 3 weeks, 3 months, 6 months, and 12 months after the surgical intervention. * Record their bladder activity between each hospital visit.
Women aged 18 to 85 years.
Patients with stress urinary incontinence or mixed urinary incontinence with a predominant stress component.
Patients with stress urinary incontinence due to cervico-urethral hypermobility or urethral hypermobility.
Patients with urethral hypermobility confirmed by Ulmsten suburethral support maneuver.
Pregnant or breastfeeding women or those not using effective contraception.
Patients with a body mass index (BMI) ≥ 35 kg/m2.
Patients with moderate stress urinary incontinence treated with physiotherapy and pelvic support exercises.
Patients with voiding disorders or at risk of performing self-catheterization.
Parallel
with treated umbilical vein allograft
Procedure/SurgerySurgical treatment of female stress urinary incontinence using a treated allogeneic umbilical vein sling
with autologous fascial pubovaginal sling
Procedure/SurgerySurgical treatment of female stress urinary incontinence using a autologous fascial pubovaginal sling
Difference between treatment groups in change from baseline to final 12-month postoperative visits in the amount of urinary leakage.
The amount of urinary leakage (grams) will be quantified by a one-hour pad test performed during patient visit at the hospital. One-hour pad test will be performed in the following way: * Subject puts on one standardized, pre-weighed pad without voiding. * 0-15 Minutes: Subject drinks 500 mL of sodium-free liquid in \< 15 min while sitting or resting. * 15 - 45 Minutes: Subject walks for 30 minutes, including climbing one flight of stairs (up and down). * 45 - 60 Minutes: Subject performs the following activities: Standing up from sitting (10 times), Coughing vigorously (10 times), Running on the spot (1 min), Bending to pick up an object from the floor (5 times), Wash hands in running water (1 min). * The weight of the pad is measured to determine the amount of leakage.
Difference between treatment groups in change from baseline to 3- and 6-month postoperative visits in the amount of urinary leakage.
The amount of urinary leakage (grams) will be quantified by a one-hour pad test performed during patient visits at the hospital.
Difference between treatment groups in the proportion of subjects who achieved a reduction of more than 50% in the amount of urinary leakage between baseline and the 12-month visit.
The amount of urinary leakage (grams) will be quantified by a one-hour pad test performed during patient visit at the hospital.
Difference between treatment groups in change from baseline to final 12-month postoperative visits in the number of incontinence episodes and pads used daily.
The number of incontinence episodes and pads used daily will be determined from a voiding calendar carried out by the patient at home over a 3-day period.
Difference between treatment groups in changes between initial and postoperative visits in frequency, severity and impact on quality of life of patients' urinary incontinence, as measured by the ICIQ-UI-SF.
The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) assess frequency, severity and impact on quality of life (QoL) of patients' urinary incontinence symptoms. The result of the ICIQ-UI SF is a composite score ranging from 0 to 21, with higher scores indicating more severe incontinence.
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