Stress Urinary IncontinenceNCT04031807
Risk Factors for Failure After Single-incision Sling Procedure in Women With Stress Urinary Incontinence
An observational study of Stress Urinary Incontinence, run by Maltepe University at 1 site in Turkey (Türkiye).
Trial summary
The main risk factors for failure after single-incision slings are reduced urethral mobility and stress urinary incontinence severity in long-term follow-up. Read more about this study
- Who is it for?
- Ages 37 to 78 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Single-Incision Sling
- Type of treatment
- Surgery or procedure
- How many people
- 132 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2019to 1 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 37 to 78 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: From September 2009 to September 2017, the medical records of the patients who underwentsingle-incision sling procedure for stress urinary incontinence without concomitant pelvic prolapse surgery were analyzed.
Who may be able to join
- Women who underwent single-incision sling procedure for stress urinary incontinence
Who cannot join
- Urodinamically proven detrusor overactivity
- Neurogenic bladder
- Previous anti-incontinence surgery including midurethral slings
- Postvoidal residual volume (PVR) >100mL
- Previous radical pelvic surgery
- Anterior pelvic organ prolapse greater than stage I
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Maltepe University Faculty of Medicine
Istanbul, 34844
About this study
Official title: Risk Factors for Failure After Single-incision Sling Procedure. Retrospective Analysis of 132 Women
The main risk factors for failure after single-incision slings are reduced urethral mobility and stress urinary incontinence severity in long-term follow-up.
Read the detailed description
The medical records of the 132 patients were retrospectively analyzed. Preoperative assessment included medical history and urogynecological examination. Patients were asked to answer validated questionnaires such as Urinary Distress Inventory (UDI-6) and Incontinence Impact Questionnaire (IIQ-7). Objective cure of SUI was defined as the absence of demonstrable leakage of urine on the cough stress test. Subjective cure was based on negative response to UDI-6, question 3. Patients were divided according to objective cure rate into two groups: cured (Group A) and failed patients (Group B).
- Conditions
- Stress Urinary Incontinence
- Being tested
- Single-Incision Sling
- Keywords
- Single-Incision Sling, Stress Urinary Incontinence, Failure
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-Incision SlingProcedure or surgery
The women with stress urinary incontinence underwent single-incision sling procedure.
What is being measured
The primary outcome is the main question the study is designed to answer.
objective cure
negative cough stress test
Measured: September 2009 to September 2017
Secondary outcomes (1)
subjective cure
negative response to Urinary Distress Inventory (UDI-6), question 3.
Measured: September 2009 to September 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2019
- Study start1 Mar 2019
- Primary completion1 Jul 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maltepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- BERNA HALILOGLU PEKER, PROFESSOR, Principal investigator, MALTEPE UNIVERSITY FACULTY OF MEDICINE DEPARTMENT OF OB&GYN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04031807
- Sponsor's protocol ID
- MaltepeU1
- Status last verified
- Oct 2021
- First submitted
- 22 Jul 2019
- Last updated
- 26 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Failure After Single-incision Sling Procedure. Retrospective Analysis of 132 Women
- ClinicalTrials.gov ID
- NCT04031807
- Acronym / sponsor ID
- MaltepeU1
- Conditions
- Stress Urinary Incontinence
- Keywords
- Single-Incision Sling, Stress Urinary Incontinence, Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Maltepe UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 24 Jul 2019 (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 main risk factors for failure after single-incision slings are reduced urethral mobility and stress urinary incontinence severity in long-term follow-up.
Detailed description
The medical records of the 132 patients were retrospectively analyzed. Preoperative assessment included medical history and urogynecological examination. Patients were asked to answer validated questionnaires such as Urinary Distress Inventory (UDI-6) and Incontinence Impact Questionnaire (IIQ-7). Objective cure of SUI was defined as the absence of demonstrable leakage of urine on the cough stress test. Subjective cure was based on negative response to UDI-6, question 3. Patients were divided according to objective cure rate into two groups: cured (Group A) and failed patients (Group B).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 37 to 78 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- From September 2009 to September 2017, the medical records of the patients who underwentsingle-incision sling procedure for stress urinary incontinence without concomitant pelvic prolapse surgery were analyzed.
Key inclusion criteria (1 listed)
- Women who underwent single-incision sling procedure for stress urinary incontinence
Key exclusion criteria (6 listed)
- Urodinamically proven detrusor overactivity
- Neurogenic bladder
- Previous anti-incontinence surgery including midurethral slings
- Postvoidal residual volume (PVR) >100mL
- Previous radical pelvic surgery
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 |
|---|---|---|
| Single-Incision SlingThe women with stress urinary incontinence underwent single-incision sling procedure. | Procedure or surgery | – |
Primary outcome
objective cure
Time frame: September 2009 to September 2017
negative cough stress test
1 secondary outcome
subjective cure
Time frame: September 2009 to September 2017
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2021.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
BERNA HALILOGLU PEKER, PROFESSOR principal investigator
MALTEPE UNIVERSITY FACULTY OF MEDICINE DEPARTMENT OF OB&GYN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress Urinary Incontinence, run by Maltepe University at 1 site in Turkey (Türkiye).
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 1 inclusion and 6 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: finished, as of the sponsor's last update on 26 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
objective cure (time frame: September 2009 to September 2017). 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 26 Oct 2021.