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.

NCT07564323 — Not applicable, Not yet recruiting, 156 participants, Saint Petersburg State University, Russia

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Optimizing the Management of Patients With Mixed Urinary Incontinence.

Registry	NCT07564323
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	156 (Estimated)
Sponsor	Saint Petersburg State University, Russia (Other)
Conditions	Mixed Urinary Incontinence
Interventions	implantation of an adjustable suburethral sling (Procedure)
Dates	start 2026-04-24 (estimated), primary completion 2027-04-24 (estimated), completion 2028-04-24 (estimated), first posted 2026-05-04, last updated 2026-05-04

-Summary

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.

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+Arms and interventions

Arm	Type	Interventions	Description
Patients with mixed urinary incontinence	Experimental	Procedure: implantation of an adjustable suburethral sling	Patients with mixed urinary incontinence, who were or were not prescribed drug therapy before the start of the study, planned for surgical treatment - implantation of a suburethral adjustable sling.

implantation of an adjustable suburethral sling (Procedure): 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.

+Outcome measures

Primary outcomes

The Overactive Bladder Symptom Score (OABSS) questionnaire [At 24 hours postoperatively compared]: Changes in scores on the Overactive Bladder Symptom Score (OABSS) questionnaire at 24 hours postoperatively compared to pre-treatment values.

+Eligibility

Sex: Female, ages: 18 Years to any

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.