Evidence map›Paper›PMID 29383480›Full record

Trial reportWorld journal of urology2018

Prostatic injection of botulinum toxin is not inferior to optimized medical therapy in the management of lower urinary tract symptoms due to benign prostatic hyperplasia: results of a randomized clinical trial.

Grégoire Robert, Aurélien Descazeaud, Gilles Karsenty, Christian Saussine, Abdel-Rahmène Azzouzi, Alexandre de la Taille, François Desgrandchamps, Antoine Faix, Marc Fourmarier, Aurore Georget and 2 more

Registry-linked trialAbstract readClinical Trial, Phase IIIEquivalence TrialMulticenter Study
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. It is linked to trial NCT01275521 (Study of the Effectiveness and the Tolerance of Intraprostatic A-botulinic Toxin Injection, in the Treatment of Symptomatic Benign Prostate Hypertrophy.), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
0.5field-weighted citation impact, top 33% 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.

NCT01275521 phase3completednot on this map

Study of the Effectiveness and the Tolerance of Intraprostatic A-botulinic Toxin Injection, in the Treatment of Symptomatic Benign Prostate Hypertrophy.

TypeinterventionalSponsorUniversity Hospital, BordeauxRan2011 to 2015Enrolled127ConditionsProstatic HyperplasiaArmsBONT-A intra-prostatic injection, Optimized medical BPH treatment
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.

  1. Pooled it
  2. Neuroscience in prostate cancer.Prostate cancer and prostatic diseases · 2026
    Review
  3. 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

12 authors at 10 institutions in 1 country.

Grégoire RobertDepartment of Urology, CHU de Bordeaux, Bordeaux Pellegrin University Hospital, Université de Bordeaux, Place Amélie Raba Léon, 33000, Bordeaux, France. gregoire.robert@chu-bordeaux.fr.
Aurélien DescazeaudDepartment of Urology, CHU de Limoges, 87042, Limoges, France.
Gilles KarsentyDepartment of Urology, CHU de Marseille, Marseille, France.
Christian SaussineDepartment of Urology, CHU de Strasbourg, Strasbourg, France.
Abdel-Rahmène AzzouziDepartment of Urology, CHU d'Angers, Angers, France.
Alexandre de la TailleDepartment of Urology, CHU Henri Mondor, APHP, Créteil, France.
François DesgrandchampsDepartment of Urology, Hôpital Saint-Louis, APHP, Paris, France.
Antoine FaixDepartment of Urology, Clinique Beausoleil, Montpellier, France.
Marc FourmarierDepartment of Urology, CH du Pays d'Aix, Aix en Provence, France.
Aurore GeorgetCHU de Bordeaux, Clinical Epidemiology Unit, Pôle de Santé Publique, 33000, Bordeaux, France.
Antoine BenardCHU de Bordeaux, Clinical Epidemiology Unit, Pôle de Santé Publique, 33000, Bordeaux, France.
Nicolas Barry DelongchampsDepartment of Urology, Hôpital Cochin, APHP, Paris, France.
Assistance Publique – Hôpitaux de Paris · FRCentre Hospitalier Universitaire de Bordeaux · FRAssistance Publique Hôpitaux de Marseille · FRCentre Hospitalier du Pays d'Aix · FRCentre Hospitalier Universitaire d'Angers · FRCentre Hospitalier Universitaire de Limoges · FRCentre Hospitalier Universitaire Henri-Mondor · FRClinique du Millénaire · FRHôpital Civil, Strasbourg · FRHôpital Pellegrin · FR

Funding

Ministère des Affaires Sociales et de la Santé PHRC 2010
6 · The paper itself

Abstract

objectiveTo explore efficacy and safety of Botulinum Neurotoxin Type A (BoNT-A) prostatic injection in patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperperplasia. MATERIALS AND

methodsA phase 3 multicenter open-labeled study randomised patients to receive BoNT-A prostatic injection or optimized medical therapy. BoNT-A injection consisted in trans-rectal injections of 200 UI in the transitional zone of the prostate. Optimal medical therapy consisted in oral medication with any drug patented for LUTS. One month (M1) after randomisation patients in the BoNT-A group were asked to stop any medical therapy related to LUTS. The main judgment criterion was the IPSS score at M4. Per-protocol analysis was performed with a non-inferiority hypothesis (ΔIPSS < 3).

results127 patients were randomised to BoNT-A (n = 64) or medical therapy (n = 63). At randomisation mean IPSS was 16.9 ± 7.2 in the BoNT-A group vs 15.7 ± 7.3 in control. In the BoNT-A group, 44 patients (73.3%) could interrupt medical therapy for LUTS from M1 to M4. At M4, mean IPSS score was 12.0 ± 6.7 in the BoNT-A group vs 11.8 ± 6.9 in control. After adjustment for baseline IPSS, delta IPSS between groups was 0.01; 95% CI [- 2.14; 2.11] leading to accept the non-inferiority hypothesis.

conclusionsFour months after BoNT-A injection, most of the patients could interrupt LUTS-related medical treatments. In these patients, IPSS improvement was not inferior to optimized medical treatment, but the study design did not allow to conclude that this improvement was related with study drug rather than with sustained placebo effect.

trial registrationNCT01275521.

Indexed as

AgedAged, 80 and overBotulinum Toxins, Type AFranceHumansInjections, IntralesionalLower Urinary Tract SymptomsMaleMiddle AgedNeuromuscular AgentsProstatic HyperplasiaTreatment OutcomeWithholding TreatmentBotulinum Toxins, Type ANeuromuscular AgentsBenign prostatic hyperplasiaBotulinum toxinLower urinary tract symptomsProstate

Identifiers

PMID29383480
OpenAlexW2785814222

What OpenQuestion holds

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Read underepoch 390

Registered trials

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.