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- Klinische proef NCT04426682
Incontinence Surgery and Urodynamics Parameters
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Istanbul, Kalkoen, 33404
- Kanuni Sultan Suleyman Training and Research Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- 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
Exclusion Criteria:
- Those with chronic diseases or medications that may cause urinary incontinence
- Patients with mixed or urge incontinence
- Patients who are not symptomatic postoperatively
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: Case-control
- Tijdsperspectieven: Retrospectief
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
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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.
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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. |
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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.
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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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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urodynamics parameters V max
Tijdsspanne: 5 YEARS
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urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; V max (voiding speed) cm3
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5 YEARS
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urodynamics parameters bladder complians
Tijdsspanne: 5 YEARS
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urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; bladder complians
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5 YEARS
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urodynamics parameters valsalva leak point pressure
Tijdsspanne: 5 YEARS
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urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; valsalva leak point pressure (mmhg)
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5 YEARS
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urodynamics parameters abdominal leak point pressure
Tijdsspanne: 5 YEARS
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urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; abdominal leak point pressure (mmhg)
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5 YEARS
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urodynamics parameters P det
Tijdsspanne: 5 YEARS
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urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; P detrusitor (P det) (mmhg)
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5 YEARS
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urodynamics parameters P abd
Tijdsspanne: 5 YEARS
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urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; P abdominal (P abd) (mmhg)
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5 YEARS
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urodynamics parameters P urethral
Tijdsspanne: 5 YEARS
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urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; P urethral (mmhg)
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5 YEARS
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urodynamics parameters UPP
Tijdsspanne: 5 YEARS
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urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; urethral pressure profile (UPP)
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5 YEARS
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Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- ATADEK / 2020.06
Informatie over medicijnen en apparaten, studiedocumenten
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