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.

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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Key information

Conditions

Mixed Urinary Incontinence

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

The Overactive Bladder Symptom Score (OABSS) questionnaire

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Saint Petersburg State University, Russia

Other

Registry information

Official study title

Optimizing the Management of Patients With Mixed Urinary Incontinence.

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2028
First posted: May 4, 2026
Registry last updated: May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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