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Incontinence Surgery and Urodynamics Parameters

9. juni 2020 oppdatert av: Pınar Kadirogulları, Kanuni Sultan Suleyman Training and Research Hospital

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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Observasjonsmessig

Registrering (Faktiske)

210

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Tyrkia
      • Istanbul, Tyrkia, 33404
        • Kanuni Sultan Suleyman Training and Research Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

N/A

Kjønn som er kvalifisert for studier

Hunn

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

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. .

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: Case-Control
  • Tidsperspektiver: Retrospektiv

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
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.
Diagnostisk test: urodynamics parameters

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.
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.
Diagnostisk test: urodynamics parameters

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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
urodynamics parameters V max
Tidsramme: 5 YEARS
urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; V max (voiding speed) cm3
5 YEARS
urodynamics parameters bladder complians
Tidsramme: 5 YEARS
urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; bladder complians
5 YEARS
urodynamics parameters valsalva leak point pressure
Tidsramme: 5 YEARS
urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; valsalva leak point pressure (mmhg)
5 YEARS
urodynamics parameters abdominal leak point pressure
Tidsramme: 5 YEARS
urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; abdominal leak point pressure (mmhg)
5 YEARS
urodynamics parameters P det
Tidsramme: 5 YEARS
urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; P detrusitor (P det) (mmhg)
5 YEARS
urodynamics parameters P abd
Tidsramme: 5 YEARS
urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; P abdominal (P abd) (mmhg)
5 YEARS
urodynamics parameters P urethral
Tidsramme: 5 YEARS
urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; P urethral (mmhg)
5 YEARS
urodynamics parameters UPP
Tidsramme: 5 YEARS
urodynamics parameters of patients before and after surgery will be examined urodynamic parameters to look at; urethral pressure profile (UPP)
5 YEARS

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. januar 2015

Primær fullføring (Faktiske)

1. januar 2020

Studiet fullført (Faktiske)

1. juni 2020

Datoer for studieregistrering

Først innsendt

5. juni 2020

Først innsendt som oppfylte QC-kriteriene

9. juni 2020

Først lagt ut (Faktiske)

11. juni 2020

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

11. juni 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. juni 2020

Sist bekreftet

1. juni 2020

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • ATADEK / 2020.06

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Studerer et amerikansk FDA-regulert enhetsprodukt

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