Evidence map›Paper›PMID 29214353›Full record

Trial reportWorld journal of urology2018

Complete bladder neck preservation promotes long-term post-prostatectomy continence without compromising midterm oncological outcome: analysis of a randomised controlled cohort.

Joanne N Nyarangi-Dix, Diana Tichy, Gencay Hatiboglu, Sascha Pahernik, Georgi Tosev, Markus Hohenfellner

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in World journal of urology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed
2.2field-weighted citation impact, top 11% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 38 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 3 institutions in 1 country.

Joanne N Nyarangi-DixDepartment of Urology, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany. Joan.Nyarangi-Dix@med.uni-heidelberg.de.
Diana TichyDepartment of Biostatistics, German Cancer Research Center, Heidelberg, Germany.
Gencay HatibogluDepartment of Urology, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.
Sascha PahernikDepartment of Urology, Klinikum Nürnberg, Nuernberg, Germany.
Georgi TosevDepartment of Urology, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.
Markus HohenfellnerDepartment of Urology, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.
Heidelberg University · DEGerman Cancer Research Center · DEKlinikum Arnsberg · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe only RCT available on complete bladder neck preservation (cBNP) during radical prostatectomy reported superior continence and QoL outcomes in the first 12 months after cBNP. We provide the first data on long-term urinary continence, QoL and biochemical recurrence (BCR) after complete bladder neck preservation in a randomised controlled cohort.

methodsAfter approval by IRB, 199 men recruited for the randomised, controlled single-blind Heidelberger cBNP Study had prostatectomy performed with (cBNP) or without (noBNP) complete bladder neck preservation. Only men with renewed consent for this follow-up were evaluated for continence, QoL outcomes and BCR by ICIQ-SF self-assessment questionnaire, Pad-use/day and PSA levels. Students-t test, Pearson´s Chi-square, Fishers exact test and multiple logistic regression analyses were applied.

resultsMean follow-up was approx. 4 years. There were no significant differences in baseline characteristics between responders/non-responders or between study groups. We noted significantly higher continence rates (p = 0.004), less pad-use (p < 0.001), reduced frequency (p = 0.023) and amount (p = 0.009) of urine loss, and higher QoL outcomes (p = 0.012) after cBNP. A younger age positively influenced continence (OR = 0.91), but the multivariate analysis found cBNP to be the only independent predictor of continence (p = 0.008; OR = 8.1). pT stage was the only predictor for positive surgical margins (PSM; p < 0.001). There was no significant difference in pT stage (p = 0.23) or BCR (p = 0.63) between study groups and also no significant correlation between BCR and presence (p = 0.26) or localisation (p = 0.11) of PSM, nerve sparing (p = 0.70), surgeon (p = 0.41), preoperative PSA (p = 0.53) or pT stage (p = 0.17). No cancer-related death was noted.

conclusionsResults of this first follow-up on a prospective randomised controlled cohort demonstrate that cBNP is associated with significantly higher continence and QoL outcomes without compromising cancer control making cBNP a novel objective during radical prostatectomy.

Indexed as

Urinary BladderAgedCohort StudiesDisease-Free SurvivalHumansKallikreinsLogistic ModelsMaleMargins of ExcisionMiddle AgedMultivariate AnalysisNeoplasm Recurrence, LocalNeoplasm StagingOrgan Sparing TreatmentsPostoperative ComplicationsProstatectomyKallikreinsKLK3 protein, humanProstate-Specific AntigenComplete bladder neck preservationProstatectomyPSA recurrenceUrinary continence

Identifiers

PMID29214353
OpenAlexW2773005984

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.