Stress Urinary IncontinenceNCT03831217
Long Term Outcome Women Who Undergone Mid-urethral Sling Surgery
An observational study of Stress Urinary Incontinence, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
The patients who underwent mid-urethral sling surgery for stress urinary incontinence will evaluate. The aim of our study is to assess long term surgical outcomes and post operative clinical findings include physical examinations, quality of life questionnaires, ultrasonographic measurements. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- mid urethral sling surgery
- Type of treatment
- Surgery or procedure
- How many people
- 58 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2019to 15 Jun 2020
- 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 Any age
- Women only
- Child, Adult, Older adult
Study population: Patients with underwent mid-urethral surgery in Ankara University Obstetrics and Gynecology Department since 2007 at any age.
Who may be able to join
- Undergoing surgery in Ankara University Obstetrics and Gynecology Department since 2007
- Patients come to follow up
Who cannot join
- inability in verbal and written communication
- impairment in cognitive functions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long Term Outcome Women Who Undergone Mid-urethral Sling Surgery Using Urogynecologic Ultrasonographic and Urodynamic Evaluation
The patients who underwent mid-urethral sling surgery for stress urinary incontinence will evaluate. The aim of our study is to assess long term surgical outcomes and post operative clinical findings include physical examinations, quality of life questionnaires, ultrasonographic measurements.
Read the detailed description
Patients who underwent mid-urethral sling surgery in Ankara University Obstetrics and Gynecology Department since 2007 will be included.
Primary outcome measure is to describe factors effecting long term success in mid-urethral sling surgery.
- Conditions
- Stress Urinary Incontinence
- Being tested
- mid urethral sling surgery
- Keywords
- Trans-Obturator Tape, Tension-Free Vaginal Tape, Mid-Urethral Sling surgeries, Stress Urinary Incontinence
- 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.
mid urethral sling surgeryProcedure or surgery
patients with clinically and/or urodynamically proven stress urinary incontinence underwent mid urethral sling surgery under general anesthesia.
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective cure rates
Objective cure is negative cough stress test.
Measured: 1-11 years
Subjective cure rates
Subjective cure is evaluated with PGI-I instrument. Patients who give 'much better' or 'better' response to the PGI question are considered subjectively cured.
Measured: 1-11 years
Secondary outcomes (3)
Tape localization
Length of urethra, length of mesh, distance between urethra and mesh, distance between mesh and bladder neck will be measured. The correlation between these parameters and surgical success will be evaluated
Measured: 1-11 years
Quality of life(QoL) after surgery
Impact of surgery on quality of life will be evaluated by QoL questionnaire
Measured: 1-11 years
Patient satisfaction
Patient satisfaction will be assessed using a 10-points Visual Analogue Scale (VAS) that ranged from ''complete achievement of my goal'' (10 points) to ''no achievement of my goal'' (0 points). Patient Global Impression of Improvement (PGI-I) and VAS scale correlation will be evaluated.
Measured: 1-11 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2019
- Study start15 Oct 2019
- Primary completion1 Jun 2020
- Study completion15 Jun 2020
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.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, kaan baydemir, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03831217
- Sponsor's protocol ID
- 29081991
- Status last verified
- Feb 2019
- First submitted
- 2 Feb 2019
- Last updated
- 26 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Outcome Women Who Undergone Mid-urethral Sling Surgery Using Urogynecologic Ultrasonographic and Urodynamic Evaluation
- ClinicalTrials.gov ID
- NCT03831217
- Acronym / sponsor ID
- 29081991
- Conditions
- Stress Urinary Incontinence
- Keywords
- Trans-Obturator Tape, Tension-Free Vaginal Tape, Mid-Urethral Sling surgeries, Stress Urinary Incontinence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 15 Jun 2020 (actual)
- First posted
- 5 Feb 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 patients who underwent mid-urethral sling surgery for stress urinary incontinence will evaluate. The aim of our study is to assess long term surgical outcomes and post operative clinical findings include physical examinations, quality of life questionnaires, ultrasonographic measurements.
Detailed description
Patients who underwent mid-urethral sling surgery in Ankara University Obstetrics and Gynecology Department since 2007 will be included.
Primary outcome measure is to describe factors effecting long term success in mid-urethral sling surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with underwent mid-urethral surgery in Ankara University Obstetrics and Gynecology Department since 2007 at any age.
Key inclusion criteria (2 listed)
- Undergoing surgery in Ankara University Obstetrics and Gynecology Department since 2007
- Patients come to follow up
Key exclusion criteria (2 listed)
- inability in verbal and written communication
- impairment in cognitive functions
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 |
|---|---|---|
| mid urethral sling surgerypatients with clinically and/or urodynamically proven stress urinary incontinence underwent mid urethral sling surgery under general anesthesia. | Procedure or surgery | – |
Primary outcome
Objective cure rates
Time frame: 1-11 years
Objective cure is negative cough stress test.
Subjective cure rates
Time frame: 1-11 years
Subjective cure is evaluated with PGI-I instrument. Patients who give 'much better' or 'better' response to the PGI question are considered subjectively cured.
3 secondary outcomes
Tape localization
Time frame: 1-11 years
Quality of life(QoL) after surgery
Time frame: 1-11 years
Patient satisfaction
Time frame: 1-11 years
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 Apr 2023.
- Individual participant dataSharing planned: Undecided
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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.
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 Ankara 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 2 inclusion and 2 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 Apr 2023. 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 rates (time frame: 1-11 years). The study lists 2 primary outcomes in all. 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 Apr 2023.