Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Predictor of Early Recovery on Urinary Continence After Laparoscopic Radical Prostatectomy

31. mars 2017 oppdatert av: Hann-Chorng Kuo, Buddhist Tzu Chi General Hospital

Predictor of Early Recovery on Urinary Continence After Laparoscopic Radical Prostatectomy: Bladder Neck Level and the Association With Urodynamic Parameters

To investigate the relationship between post-operative bladder neck levels and urodynamic parameters and their effect on urinary incontinence after laparoscopic radical prostatectomy (LRP). Forty-eight consecutive patients undergoing LRP were retrospectively reviewed. All patients had investigated by retrograde cystography after LRP and were grouped according their bladder neck position: Level 0: bladder neck at or above the superior margin of the symphysis pubis (SMSP), Level -1: bladder neck at <2 cm below SMSP, and Level -2: bladder neck at >2 cm below SMSP. Urodynamic studies were carried out at baseline, 3 and 6 months post-operatively. Early recovery of urinary continence was defined as no urine leakage or only one pad/day used within 3 months after surgery. Demographic characteristics, changes of urodynamic parameters and continence outcomes were analyzed.

Studieoversikt

Status

Fullført

Forhold

Detaljert beskrivelse

Laparoscopic radical prostatectomy (LRP) is effective in treating localized prostate cancer with good long-term oncological outcomes. Urinary incontinence, which is a bothersome complication with a negative effect on the patient's quality of life, remains a relevant problem after LRP, despite the improvements in the surgical technique. More than 80% of patients undergoing radical prostatectomy encounter urinary incontinence immediately after catheter removal, but the bladder condition can generally stabilize within two years after operation. Among the patients undergoing LRP, persistent urinary incontinence has been reported in 4-30% of patients, and further treatment is often required.

Definite evaluation for the voiding function has been recommended for patients with prolonged post-prostatectomy urinary incontinence (PPI). To improve quality of life after LRP, early recovery of urinary continence is an important concern for patients. Several studies have investigated the predictive factors of early recovery of urinary continence after prostatectomy, including the amount of urine loss after catheter removal, pelvic floor muscle function, a nerve-sparing technique, and the membranous urethral length loss ratio.

Other factors relating to the early recovery of urinary continence include post-operative anatomy of the lower urinary tract, such as the length of the membranous urethra and the level of the vesicourethral junction. However, there has been no consensus on the standard criteria that should be used to measure the structural changes, and the relationship between the urodynamic change and the anatomical morphology remains unclear. In this study, investigators study the relationship between the urodynamic parameters and the bladder neck levels after LRP, and their effects on the early recovery of urinary incontinence.

This study was a retrospective analysis. From 2011 to 2014, a total of 48 consecutive patients with localized prostatic cancer underwent LRP in single medical center by two experienced surgeons. Videourodynamic study was performed before operation (baseline) and at 3 and 6 months after operation. The Ethics Committee of the hospital approved this study and written informed consent was waived because the study was a retrospective analysis. The principles of Helsinki Declaration were followed throughout the study.

The urodynamic parameters were measured and recorded including first sensation of filling (FSF), maximum flow rate (Qmax), detrusor pressure at Qmax (PdetQmax), voided volume, cystometric bladder capacity (CBC), bladder compliance, post-void residual (PVR) volume, maximal urethral closure pressure (MUCP) and functional profile length (FPL). The urodynamic parameters were compared between baseline and different time-points after LRP.

The BN level was evaluated by retrograde cystography, which was routinely performed 7 to 14 days after LRP to evaluate the condition of anastomosis. The image was obtained anteroposteriorly after infusing 100-150 mL of contrast solution into the bladder while the patient was in standing position. The distance between the bladder neck and the superior margin of the symphysis pubis (SMSP) was then measured by the same urologist. The bladder neck level was graded on a three-point scale: a bladder neck level at or above the SMSP was marked as level 0, a bladder neck level with a distance less than 2 cm below the SMSP was marked as level -1, and bladder neck levels 2 or more cm below the SMSP was labeled as level -2.

The patient's urinary continence status was evaluated on direct visits and via questionnaires during follow-up periods at 3, 6, and 12 months post-operatively. Patients without urine leakage in their daily life and those who used only one pad per day for safety reasons without limitation in their daily activities were defined as "urinary continent". Otherwise, the patients were defined as "urinary incontinent". Regaining continence within 3 months after LRP was considered early recovery of urinary continence.

The data was collected retrospectively by chart review. The variables among continent and incontinent patients were evaluated by univariate analysis (t-test for continuous variables and Chi-square for categorical variables ). The ANOVA test was use to compare the urodynamic parameters between different BN levels. Statistical analysis was performed using SPSS 20.0 statistical software.

Studietype

Observasjonsmessig

Registrering (Faktiske)

48

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

40 år til 90 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Mann

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Consecutive patients with localized prostate cancer underwent laparoscopic radical prostatectomy

Beskrivelse

Inclusion Criteria:

  • Patients with localized prostate cancer underwent laparoscopic radical prostatectomy

Exclusion Criteria:

  • Patients who did not have regular follow-up after surgery

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
urinary continence at 3 months after laparoscopic radical prostatectomy
Tidsramme: from baseline to 3 months
Patients without urine leakage in their daily life and those who used only one pad per day for safety reasons without limitation in their daily activities at 3 months after laparoscopic radical prostatectomy were defined as "urinary continent"
from baseline to 3 months

Samarbeidspartnere og etterforskere

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

Etterforskere

  • Hovedetterforsker: HannChorng Kuo, M.D., Buddhist Tzu Chi General 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 2017

Primær fullføring (Faktiske)

1. mars 2017

Studiet fullført (Faktiske)

1. mars 2017

Datoer for studieregistrering

Først innsendt

27. mars 2017

Først innsendt som oppfylte QC-kriteriene

27. mars 2017

Først lagt ut (Faktiske)

31. mars 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. april 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

31. mars 2017

Sist bekreftet

1. mars 2017

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

No plan to share data with other researchers

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Urininkontinens

Abonnere