Evidence map›Paper›PMID 35448895›Full record

Trial reportToxins2022

Effectiveness and Safety of Intracavernosal IncobotulinumtoxinA (Xeomin

Francois Giuliano, Pierre Denys, Charles Joussain

2 registry-linked trialsOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Toxins, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
1.8field-weighted citation impact, top 16% 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.

NCT05196308 phase2completednot on this map

Efficacy of Intracavernosal (Xeomin®) 100U as add-on Therapy to Sildenafil 100 mg on Demand Compared to Sildenafil 100 mg on Demand for the Treatment of Erectile Dysfunction (ED) Not Sufficiently Responsive to Standard Therapy With Phosphodiesterase Type 5 Inhibitors

TypeinterventionalSponsorAssistance Publique - Hôpitaux de ParisRan2022 to 2024Enrolled226ConditionsErectile DysfunctionArmsInvestigational product administration Xeomin® (MERZ PHARMACEUTICALS GMBH), Placebo administration
NCT07537855 phase2not yet recruitingnot on this mapstarted 2026, after this paper: background citation

Clinical Efficacy of Intracavernosal Xeomin as an Adjunctive Therapy to on Demand Tadalafil 20 mg for the Treatment of Mild to Moderate Erectile Dysfunction: A Randomized Crossover Pilot Study

TypeinterventionalSponsorNorthwestern UniversityRan2026 to 2028Enrolled30ConditionsErectile DysfunctionArmsIncobotulinumtoxinA (100 Units), Placebo, Tadalafil 20 MG
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 13 citations in OpenAlex.

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

3 authors at 1 institution in 1 country.

Francois GiulianoNeuro-Uro-Andrology R. Poincare University Hospital, AP-HP, 104 Bvd R. Poincare, 92380 Garches, France.
Pierre DenysNeuro-Uro-Andrology R. Poincare University Hospital, AP-HP, 104 Bvd R. Poincare, 92380 Garches, France.ORCID 0000-0002-4831-6499
Charles JoussainNeuro-Uro-Andrology R. Poincare University Hospital, AP-HP, 104 Bvd R. Poincare, 92380 Garches, France.
Université de Versailles Saint-Quentin-en-Yvelines · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Registered pharmacological treatments are insufficiently effective for erectile dysfunction (ED) in around 30% of affected men. Intracavernosal injection (ICI) of ona- and abobotulinumtoxinA can reduce ED in insufficient responders. We aimed to assess the safety and effectiveness of incobotulinumtoxinA ICI as an add-on therapy to phosphodiesterase-type 5 inhibitors (PDE5-Is) or prostaglandinE1 ICIs (PGE1 ICIs) to treat ED that did not respond sufficiently to this treatment alone. We retrospectively analyzed data from 66 men with difficult to treat ED treated with single or repeated incobotulinumtoxinA 100U ICI as an add-on therapy. Response rate (increase in International Index of Erectile Function-Erectile Function domain score ≥ the minimum clinically important difference) was 52% (median (1st-3rd quartile) 43.5 (34-71) days post-incobotulinumtoxinA ICI). ED etiology (except spinal cord injury) and severity did not influence effectiveness. Only a clinically significant response to the 1st injection predicted a request for a 2nd injection (OR = 5.6, 95%, CI 1.6-19.4). Three men reported mild penile pain during the injection. These results provide preliminary evidence for the effectiveness and safety of incobotulinumtoxinA ICI as an add-on therapy to treat ED that is insufficiently responsive to standard care and provides support for the multicenter randomized clinical trial NCT05196308.

Indexed as

Erectile DysfunctionBotulinum Toxins, Type AFemaleHumansMalePenile ErectionPhosphodiesterase 5 InhibitorsRetrospective StudiesTreatment OutcomeBotulinum Toxins, Type AincobotulinumtoxinAPhosphodiesterase 5 Inhibitorsbotulinum toxin Acombination therapyerectile dysfunctionnon-responderspharmacology

Identifiers

PMID35448895
PMCPMC9030535
OpenAlexW4224251286

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.