About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- with treated umbilical vein allograft
- with autologous fascial pubovaginal sling