Urinary Incontinence, StressUPMUSFNCT02337374
Predictive Role of Urodynamics on Mid-urethral Sling Failure
An observational study of Urinary Incontinence, Stress, run by Kanuni Sultan Suleyman Training and Research Hospital.
Trial summary
Purpose The aim of this study is to investigate the contribution of preoperative urodynamics to mid-urethral slings (MUS) success for developing an algorithm that uses conventional and easily accessible tools Methods Women with stress urinary incontinence and who desired surgical correction of their incontinence were… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Urinary Incontinence, Stress
- What is being tested?
- Midurethral sling mesh
- Type of treatment
- Medical device
- How many people
- 242 participants
- Where
- No sites listed yet
- Study dates
- Jun 2010to Feb 2012
- 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 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with stress urinary incontinence and who desired surgical correction of their incontinence
Who may be able to join
- Documented pure or predominant SUI symptoms for at least 3 months, along with a positive standardized urinary stress test
Who cannot join
- prior incontinence surgery, post-void residual volumes of greater than 100 ml, a history of chronic inguinal or vulvar abscess, hidradenitis suppurativa, genitourinary fistula or urethral diverticulum, reversible cause of incontinence (i.e., drug effect), or any contraindication to surgery
About this study
Official title: Do Urodynamics Superior to 25 Years of Clinical Expertise Predict Mid-Urethral Sling Failure?
Purpose The aim of this study is to investigate the contribution of preoperative urodynamics to mid-urethral slings (MUS) success for developing an algorithm that uses conventional and easily accessible tools Methods Women with stress urinary incontinence and who desired surgical correction of their incontinence were included in the study. The selection of the procedure was according to an algorithm used in an institution developed by a chief of urogynecology department who had 25 years of urogynecology experience. Urodynamic and baseline factors that may be associated with surgery failure were analyzed in MUS failure.
- Conditions
- Urinary Incontinence, Stress
- Being tested
- Midurethral sling mesh
- Keywords
- Urodynamics, Midurethral sling, Transobturator tape (TOT), Tension free vaginal tape (TVT)
- 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.
Midurethral sling meshDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Mid urethral sling surgery failure
Measured: after june 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2015 (estimated)
- Study startJun 2010
- Primary completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Incontinence, StressStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, serdar aydin, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02337374
- Sponsor's protocol ID
- KSSRTH2010-06
- Acronym
- UPMUSF
- Status last verified
- Jan 2015
- First submitted
- 9 Jan 2015
- Last updated
- 13 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Urodynamics Superior to 25 Years of Clinical Expertise Predict Mid-Urethral Sling Failure?
- ClinicalTrials.gov ID
- NCT02337374
- Acronym / sponsor ID
- UPMUSF / KSSRTH2010-06
- Conditions
- Urinary Incontinence, Stress
- Keywords
- Urodynamics, Midurethral sling, Transobturator tape (TOT), Tension free vaginal tape (TVT)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Feb 2012 (actual)
- First posted
- 13 Jan 2015 (estimated)
- 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.
Purpose The aim of this study is to investigate the contribution of preoperative urodynamics to mid-urethral slings (MUS) success for developing an algorithm that uses conventional and easily accessible tools Methods Women with stress urinary incontinence and who desired surgical correction of their incontinence were included in the study. The selection of the procedure was according to an algorithm used in an institution developed by a chief of urogynecology department who had 25 years of urogynecology experience. Urodynamic and baseline factors that may be associated with surgery failure were analyzed in MUS failure.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with stress urinary incontinence and who desired surgical correction of their incontinence
Key inclusion criteria (1 listed)
- Documented pure or predominant SUI symptoms for at least 3 months, along with a positive standardized urinary stress test
Key exclusion criteria (1 listed)
- prior incontinence surgery, post-void residual volumes of greater than 100 ml, a history of chronic inguinal or vulvar abscess, hidradenitis suppurativa, genitourinary fistula or urethral diverticulum, reversible cause of incontinence (i.e., drug effect), or any contraindication to 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 |
|---|---|---|
| Midurethral sling mesh | Device | – |
Primary outcome
Mid urethral sling surgery failure
Time frame: after june 2010
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 13 Jan 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Incontinence, Stress, run by Kanuni Sultan Suleyman Training and Research Hospital.
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 1 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 13 Jan 2015. 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?
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?
Mid urethral sling surgery failure (time frame: after june 2010). 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 13 Jan 2015.