IncontinenceNCT04426682
Incontinence Surgery and Urodynamics Parameters
An observational study of Incontinence and Surgery, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
In patients who have previously had incontinence surgery due to stress incontinence (Midurethral slings (tvt, tot, etc.)), the symptoms may return in the following years and the patient can reapply with urinary incontinence. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Incontinence, Surgery
- What is being tested?
- urodynamics parameters
- How many people
- 210 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2015to 1 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 18 to 65 years
- Women only
- Adult, Older adult
Study population: The files of the patients will be accessed through the system, and patients who have had incontinence surgery and applied again due to recurrence will be selected. The data of these patients will be scanned and recorded. The control group will also be created in the same way, and data of patients who have undergone surgery and have no urinary incontinence and who have postoperative urodynamics will be recorded. .
Who may be able to join
- Patients who have previously undergone surgery for stress incontinence
- Those who are symptomatic again in their post-operative follow-up (urinary incontinence),
- Patients who underwent preoperative and postoperative urodynamics
Who cannot join
- Those with chronic diseases or medications that may cause urinary incontinence
- Patients with mixed or urge incontinence
- Patients who are not symptomatic postoperatively
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kanuni Sultan Süleyman Training and Research Hospital
Istanbul, 33404
About this study
Official title: In Patients Who Underwent Incontinence Surgery and Who Had Postoperative Recurrence Comparison of Urodynamics Parameters Performed in Preoperative and Postoperative Period
In patients who have previously had incontinence surgery due to stress incontinence (Midurethral slings (tvt, tot, etc.)), the symptoms may return in the following years and the patient can reapply with urinary incontinence. Urodynamic evaluation is important before stress incontinence surgery to confirm clinical diagnosis based on symptoms and findings and to determine the factors that may affect the effectiveness of surgery and the possibility of complications. Urodynamics evaluation is performed in the preoperative period in patients scheduled for incontinence. Urodynamics evaluation is performed again in patients who applied with post-operative recurrence due to surgery failure or different reasons.
It is aimed to show whether there is a difference between the urodynamics parameters of these patients who were examined preoperatively and the urodynamics parameters examined in case of postoperative failure. Thus, the primary goal; to show which of these parameters has deterioration or if the surgical method is insufficient if it is within certain limits or urinary incontinence may recur.
- Conditions
- Incontinence, Surgery
- Being tested
- urodynamics parameters
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
urodynamics parametersDiagnostic test
Urodynamics evaluation is performed in the preoperative period in patients whose operation is planned due to incontinence.
Urodynamics evaluation is performed again in patients who applied with postoperative relapse due to surgery failure or different reasons.
It will be shown whether there is a difference between the urodynamics parameters of preoperatively examined patients and those of urodynamics examined in case of postoperative failure.
| Study group | Role | What they receive |
|---|---|---|
| post-operative urinary incontinents | In patients who have previously had incontinence surgery due to stress incontinence, symptoms may return in the following years, and the patient may reapply with urinary incontinence. The first group will consist of postoperative urinary incontinence recurrent patients. Patients whose urodynamics are reperformed due to recurrence are the study group. Receives: Diagnostic Test: urodynamics parameters | |
| without postoperative urinary incontinence | Patients who previously had incontinence surgery due to stress incontinence and who did not have postopertive urinary incontinence but whose urodynamics were repeated during the routine controls will constitute the control group. Receives: Diagnostic Test: urodynamics parameters |
What is being measured
The primary outcome is the main question the study is designed to answer.
urodynamics parameters V max
urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; V max (voiding speed) cm3
Measured: 5 YEARS
urodynamics parameters bladder complians
urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; bladder complians
Measured: 5 YEARS
urodynamics parameters valsalva leak point pressure
urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; valsalva leak point pressure (mmhg)
Measured: 5 YEARS
urodynamics parameters abdominal leak point pressure
urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; abdominal leak point pressure (mmhg)
Measured: 5 YEARS
urodynamics parameters P det
urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; P detrusitor (P det) (mmhg)
Measured: 5 YEARS
urodynamics parameters P abd
urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; P abdominal (P abd) (mmhg)
Measured: 5 YEARS
urodynamics parameters P urethral
urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; P urethral (mmhg)
Measured: 5 YEARS
urodynamics parameters UPP
urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; urethral pressure profile (UPP)
Measured: 5 YEARS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start1 Jan 2015
- Primary completion1 Jan 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pınar Kadirogulları, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04426682
- Sponsor's protocol ID
- ATADEK / 2020.06
- Status last verified
- Jun 2020
- First submitted
- 5 Jun 2020
- Last updated
- 11 Jun 2020
- 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 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Patients Who Underwent Incontinence Surgery and Who Had Postoperative Recurrence Comparison of Urodynamics Parameters Performed in Preoperative and Postoperative Period
- ClinicalTrials.gov ID
- NCT04426682
- Acronym / sponsor ID
- ATADEK / 2020.06
- Conditions
- Incontinence, Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 11 Jun 2020 (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.
In patients who have previously had incontinence surgery due to stress incontinence (Midurethral slings (tvt, tot, etc.)), the symptoms may return in the following years and the patient can reapply with urinary incontinence. Urodynamic evaluation is important before stress incontinence surgery to confirm clinical diagnosis based on symptoms and findings and to determine the factors that may affect the effectiveness of surgery and the possibility of complications. Urodynamics evaluation is performed in the preoperative period in patients scheduled for incontinence. Urodynamics evaluation is performed again in patients who applied with post-operative recurrence due to surgery failure or different reasons.
It is aimed to show whether there is a difference between the urodynamics parameters of these patients who were examined preoperatively and the urodynamics parameters examined in case of postoperative failure. Thus, the primary goal; to show which of these parameters has deterioration or if the surgical method is insufficient if it is within certain limits or urinary incontinence may recur.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| post-operative urinary incontinents | – | Diagnostic Test: urodynamics parametersIn patients who have previously had incontinence surgery due to stress incontinence, symptoms may return in the following years, and the patient may reapply with urinary incontinence. The first group will consist of postoperative urinary incontinence recurrent patients. Patients whose urodynamics are reperformed due to recurrence are the study group. |
| without postoperative urinary incontinence | – | Diagnostic Test: urodynamics parametersPatients who previously had incontinence surgery due to stress incontinence and who did not have postopertive urinary incontinence but whose urodynamics were repeated during the routine controls will constitute the control group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- The files of the patients will be accessed through the system, and patients who have had incontinence surgery and applied again due to recurrence will be selected. The data of these patients will be scanned and recorded. The control group will also be created in the same way, and data of patients who have undergone surgery and have no urinary incontinence and who have postoperative urodynamics will be recorded. .
Key inclusion criteria (3 listed)
- Patients who have previously undergone surgery for stress incontinence
- Those who are symptomatic again in their post-operative follow-up (urinary incontinence),
- Patients who underwent preoperative and postoperative urodynamics
Key exclusion criteria (3 listed)
- Those with chronic diseases or medications that may cause urinary incontinence
- Patients with mixed or urge incontinence
- Patients who are not symptomatic postoperatively
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 |
|---|---|---|
| urodynamics parametersUrodynamics evaluation is performed in the preoperative period in patients whose operation is planned due to incontinence. Urodynamics evaluation is performed again in patients who applied with postoperative relapse due to surgery failure or different reasons. It will be shown whether there is a difference between the urodynamics parameters of preoperatively examined patients and those of urodynamics examined in case of postoperative failure. | Diagnostic test | post-operative urinary incontinents, without postoperative urinary incontinence |
Primary outcome
urodynamics parameters V max
Time frame: 5 YEARS
urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; V max (voiding speed) cm3
urodynamics parameters bladder complians
Time frame: 5 YEARS
urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; bladder complians
urodynamics parameters valsalva leak point pressure
Time frame: 5 YEARS
urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; valsalva leak point pressure (mmhg)
urodynamics parameters abdominal leak point pressure
Time frame: 5 YEARS
urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; abdominal leak point pressure (mmhg)
urodynamics parameters P det
Time frame: 5 YEARS
urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; P detrusitor (P det) (mmhg)
urodynamics parameters P abd
Time frame: 5 YEARS
urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; P abdominal (P abd) (mmhg)
urodynamics parameters P urethral
Time frame: 5 YEARS
urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; P urethral (mmhg)
urodynamics parameters UPP
Time frame: 5 YEARS
urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; urethral pressure profile (UPP)
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 11 Jun 2020.
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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 Incontinence and Surgery, run by Kanuni Sultan Suleyman Training and Research Hospital 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 3 inclusion and 3 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 11 Jun 2020. 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?
urodynamics parameters V max (time frame: 5 YEARS). The study lists 8 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 11 Jun 2020; AzTrials last refreshed its copy on 28 Oct 2026.