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 Yet Recruiting

• 1 other identifier: 19.02.26
• Study Type: interventional
• Target: 156
• Locations: 0 countries
• Sites: N/A

Brief 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. 1.What is the effectiveness of an adjustable suburethral sling in patients with mixed urinary incontinence?
2. 2.How do preoperative medications and other factors affect the effectiveness of adjustable suburethral sling implantation?
3. 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.

Conditions

Mixed Urinary Incontinence

Keywords

mixed urinary incontinence, adjustable suburethral sling

Outcome Measures

Primary Outcomes (1)

• The Overactive Bladder Symptom Score (OABSS) questionnaire

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

  At 24 hours postoperatively compared

Study Arms (1)

Patients with mixed urinary incontinence

EXPERIMENTAL

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.

Procedure: implantation of an adjustable suburethral sling

Interventions

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.

Patients with mixed urinary incontinence

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Saint Petersburg State University, Russia: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Urologist

Study Record Dates

• First Submitted: April 26, 2026
• First Posted: May 4, 2026
• Study Start: April 24, 2026
• Primary Completion (Estimated): April 24, 2027
• Study Completion (Estimated): April 24, 2028
• Last Updated: May 4, 2026

Record last verified: 2026-04