- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Istanbul, Tacchino, 33404
- Kanuni Sultan Suleyman Training and Research Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: Caso di controllo
- Prospettive temporali: Retrospettiva
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
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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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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urodynamics parameters V max
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 5 YEARS
|
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
|
Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- ATADEK / 2020.06
Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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