Implantation of an Adjustable Suburethral Sling is an Effective Treatment Method for Patients With Mixed Urinary Incontinence of Moderate to Severe Severity, After Which the Severity of the Stress and Urgency Components is Reduced.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: implantation of an adjustable suburethral sling.
- Who it may be relevant to
- Registry conditions: Mixed Urinary Incontinence. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Optimizing the Management of Patients With Mixed Urinary Incontinence.
Overview
The aim of this clinical study is to optimize treatment outcomes in patients with mixed forms of urinary incontinence by implanting an adjustable suburethral sling and to determine factors influencing treatment effectiveness. The main questions it aims to answer are: 1. What is the effectiveness of an adjustable suburethral sling in patients with mixed urinary incontinence? 2. How do preoperative medications and other factors affect the effectiveness of adjustable suburethral sling implantation? 3. How does quality of life change in these patients after surgery? Participants will undergo implantation of an adjustable suburethral sling. Postoperatively, the effectiveness of the sling for mixed urinary incontinence will be assessed. Predictors of treatment effectiveness will also be identified. Patients will be examined 24 hours after surgery, 2 months later, and 1 year later.
Interventions
- Procedure implantation of an adjustable suburethral sling
Surgical access will be achieved through the anterior vaginal wall, projecting toward the middle third of the urethra. The UroSling endoprosthesis will be inserted using the standard technique.
Primary outcome measures
- The Overactive Bladder Symptom Score (OABSS) questionnaire [Time frame: At 24 hours postoperatively compared]
Eligibility criteria
Inclusion criteria
- Women over 18 years of age.
- Mixed urinary incontinence (stress and urgency components, with the stress component being predominant or equal) of moderate to severe severity, confirmed by questionnaire data.
- Signed informed consent to participate in the study.
Exclusion criteria
- Isolated stress or urge urinary incontinence.
- Contraindications to diagnosis and treatment.
- Obstructive urination, large residual urine volume.
- Chronic pelvic pain syndrome.
- Pelvic organ prolapse (grade 2 or higher according to POP-Q).
- History of any suburethral sling implantation.
- History of surgical treatment for pelvic organ prolapse.
- Pregnancy.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07564323 · 19.02.26