- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
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Istanbul, Krocan, 33404
- Kanuni Sultan Suleyman Training and Research Hospital
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: Case-Control
- Časové perspektivy: Retrospektivní
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
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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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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urodynamics parameters V max
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
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