Mixed Urinary IncontinenceNCT07564323
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.
A study testing implantation of an adjustable suburethral sling in people with Mixed Urinary Incontinence, run by Saint Petersburg State University, Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Mixed Urinary Incontinence
- What is being tested?
- implantation of an adjustable suburethral sling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- No sites listed yet
- Study dates
- 24 Apr 2026to 24 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Optimizing the Management of Patients With Mixed Urinary Incontinence.
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:
- What is the effectiveness of an adjustable suburethral sling in patients with mixed urinary incontinence?
- How do preoperative medications and other factors affect the effectiveness of adjustable suburethral sling implantation?
- 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.
- Conditions
- Mixed Urinary Incontinence
- Being tested
- implantation of an adjustable suburethral sling
- Keywords
- mixed urinary incontinence, adjustable suburethral sling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implantation of an adjustable suburethral slingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: implantation of an adjustable suburethral sling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 24 hours postoperatively compared
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start24 Apr 2026 (estimated)
- Primary completion24 Apr 2027 (estimated)
- Study completion24 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mixed Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saint Petersburg State University, Russia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brednikhina Irina, Saint Petersburg State University, Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07564323
- Sponsor's protocol ID
- 19.02.26
- Status last verified
- Apr 2026
- First submitted
- 26 Apr 2026
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing the Management of Patients With Mixed Urinary Incontinence.
- ClinicalTrials.gov ID
- NCT07564323
- Acronym / sponsor ID
- 19.02.26
- Conditions
- Mixed Urinary Incontinence
- Keywords
- mixed urinary incontinence, adjustable suburethral sling
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Saint Petersburg State University, RussiaUniversity, hospital or other
- Study start
- 24 Apr 2026 (estimated)
- Primary completion
- 24 Apr 2027 (estimated)
- Study completion
- 24 Apr 2028 (estimated)
- First posted
- 4 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What is the effectiveness of an adjustable suburethral sling in patients with mixed urinary incontinence?
- How do preoperative medications and other factors affect the effectiveness of adjustable suburethral sling implantation?
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with mixed urinary incontinence | Experimental | Procedure: implantation of an adjustable suburethral slingPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| implantation of an adjustable suburethral slingSurgical 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. | Procedure or surgery | Patients with mixed urinary incontinence |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing implantation of an adjustable suburethral sling in people with Mixed Urinary Incontinence, run by Saint Petersburg State University, Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Overactive Bladder Symptom Score (OABSS) questionnaire (time frame: At 24 hours postoperatively compared). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.