Evidence map›Paper›PMID 25155034›Full record

Trial reportWorld journal of urology2015

Effects of tadalafil once daily or on demand versus placebo on time to recovery of erectile function in patients after bilateral nerve-sparing radical prostatectomy.

Ignacio Moncada, Fermín R de Bethencourt, Enrique Lledó-García, Javier Romero-Otero, Carmen Turbi, Hartwig Büttner, Carsten Henneges, Juan I Martinez Salamanca

Open access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in World journal of urology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
2.5field-weighted citation impact, top 12% 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

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 27 citations in OpenAlex.

  1. Penile rehabilitation for postprostatectomy erectile dysfunction.The Cochrane database of systematic reviews · 2018
    Pooled it
  2. Trial
  3. Article
  4. Review
  5. Review
  6. Article
  7. Article
  8. Review
  9. Postprostatectomy Erectile Dysfunction: A Review.The world journal of men's health · 2016
    Review
  10. Penile rehabilitation after radical prostatectomy: does it work?Translational andrology and urology · 2015
    Review
  11. PDE-5 inhibitors should be used post radical prostatectomy as erection function rehabilitation? | Opinion: Yes.International braz j urol : official journal of the Brazilian Society of Urology
    Review
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

8 authors at 7 institutions in 3 countries.

Ignacio MoncadaDepartment of Urology, Hospital La Zarzuela, Madrid, Spain, ignacio@moncada.name.
Fermín R de Bethencourt
Enrique Lledó-García
Javier Romero-Otero
Carmen Turbi
Hartwig Büttner
Carsten Henneges
Juan I Martinez Salamanca
Eli Lilly (Germany) · DEEli Lilly (Spain) · ESHospital General Universitario Gregorio Marañón · ESHospital La Luz · ESHospital Universitario 12 De Octubre · ESHospital Universitario La Paz · ESHospital Universitario Puerta de Hierro Majadahonda · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeWe report time to erectile function (EF)-recovery data from a multicenter, randomized, double-blind, double-dummy, placebo-controlled trial evaluating tadalafil started after bilateral nerve-sparing radical prostatectomy (nsRP).

methodsPatients ≤68 years were randomized post-nsRP 1:1:1 to 9-month double-blind treatment (DBT) with tadalafil 5 mg once daily (OaD), 20 mg tadalafil on demand ("pro-re-nata"; PRN), or placebo, followed by 6-week drug-free washout (DFW) and 3-month open-label OaD treatment. Secondary outcome measures included Kaplan-Meier estimates of time to EF-recovery (IIEF-EF ≥ 22) during DBT (Cox proportional hazard model adjusting for treatment, age, and country).

resultsA total of 423 patients were randomized to tadalafil OaD (N = 139), PRN (N = 143), and placebo (N = 141); 114/122/155 completed DBT. The proportion of patients achieving IIEF-EF ≥22 at some point during DBT with OaD, PRN, and placebo was 29.5, 23.9, and 18.4 %, respectively. DBT was too short to achieve EF-recovery (IIEF-EF ≥ 22) in >50 % of patients; median time to EF-recovery was non-estimable. Time for 25 % of patients to achieve EF-recovery (95 % CI) was 5.8 (4.9, 9.2) months for OaD versus 9.0 (5.5, 9.2) and 9.3 (9.0, 9.9) months for PRN and placebo, respectively. Showing a significant overall treatment effect (p = 0.038), the probability for EF-recovery was significantly higher for OaD versus placebo [hazard ratio (HR); 95 % CI 1.9; 1.2, 3.1; p = 0.011], but not for PRN versus placebo (p = 0.140). Of 57 OaD patients (41.0 %) with ED improved (by ≥1 IIEF-EF severity grade) at the end of DBT, 16 (28.1 % of 57) maintained this improvement through DFW and 27 (47.4 %) declined but maintained improvement from baseline after DFW.

conclusionsData suggest that the use of tadalafil OaD can significantly shorten the time to EF-recovery post-nsRP compared with placebo.

Indexed as

AgedDouble-Blind MethodDrug Administration ScheduleErectile DysfunctionHumansMaleMiddle AgedPenile ErectionPhosphodiesterase 5 InhibitorsProstatectomyRecovery of FunctionTadalafilTreatment OutcomePhosphodiesterase 5 InhibitorsTadalafil

Identifiers

PMID25155034
PMCPMC4480825
OpenAlexW2079977127

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.