Evidence map›Paper›PMID 32342279›Full record

ArticleClinical drug investigation2020

Efficacy of Collagenase Clostridium histolyticum (Xiapex

Andrea Cocci, Fabrizio Di Maida, Giorgio Ivan Russo, Paolo Capogrosso, Lotti Francesco, Michele Rizzo, Marina Di Mauro, Andrea Salonia, Gianmartin Cito, Marco Falcone and 6 more

Erratum issuedOpen access · greenAbstract read
PubMed Publisher
In one paragraph

Article in Clinical drug investigation, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.2field-weighted citation impact, top 22% 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

2 citing papers in PubMed, 15 citations in OpenAlex.

  1. Review
  2. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors at 6 institutions in 2 countries.

Andrea CocciDepartment of Urology, Careggi Hospital, University of Florence, Viale S. Luca, 50134, Florence, FI, Italy.
Fabrizio Di MaidaDepartment of Urology, Careggi Hospital, University of Florence, Viale S. Luca, 50134, Florence, FI, Italy. fabrizio.dimaida@unifi.it.
Giorgio Ivan RussoUrology Section, Department of Surgery, University of Catania, Catania, Italy.
Paolo CapogrossoDivision of Experimental Oncology/Unit of Urology, Urological Research Institute, IRCCS Ospedale San Raffaele, Milan, Italy.
Lotti FrancescoDepartment of Experimental and Clinical Biomedical Sciences, University of Florence, Florence, Italy.
Michele RizzoDepartment of Urology, University of Trieste, Trieste, Italy.
Marina Di MauroUrology Section, Department of Surgery, University of Catania, Catania, Italy.
Andrea SaloniaDivision of Experimental Oncology/Unit of Urology, Urological Research Institute, IRCCS Ospedale San Raffaele, Milan, Italy.
Gianmartin CitoDepartment of Urology, Careggi Hospital, University of Florence, Viale S. Luca, 50134, Florence, FI, Italy.
Marco FalconeUrology Clinic, A.O.U. Città della Salute e della Scienza di Torino, University of Turin, Turin, Italy.
Andrea RomanoDepartment of Urology, Careggi Hospital, University of Florence, Viale S. Luca, 50134, Florence, FI, Italy.
Gaia PolloniPsychosexuologist, Como, Italy.
Juan Ignacio Martinez-SalamancaDepartment of Urology, Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, Spain.
Esaù Fernández-PascualDepartment of Urology, Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, Spain.
Andrea MinerviniDepartment of Urology, Careggi Hospital, University of Florence, Viale S. Luca, 50134, Florence, FI, Italy.
Nicola MondainiAndrology Center, Villa Donatello Hospital, Florence, Italy.
University of Florence · ITHospital Universitario Puerta de Hierro Majadahonda · ESIRCCS Ospedale San Raffaele · ITUniversity of Catania · ITUniversity of Trieste · ITUniversity of Turin · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND 

objectivePlaque formation ordinarily takes place in the acute phase of Peyronie's disease. There is no unanimous consent regarding the management of the acute phase of Peyronie's disease. The objective of this study was to evaluate the advantages of using a single intralesional injection of collagenase Clostridium histolyticum in patients with the active phase of Peyronie's disease and to assess its effect on disease progression by reducing penile curvature and ameliorating pain during sexual intercourse.

methodsSexually active men aged older than 18 years with the acute phase of Peyronie's disease were enrolled. All patients received treatment with a single intralesional injection of collagenase Clostridium histolyticum. The primary outcome of the study was the change in penile curvature after treatment while secondary outcomes were the change in sexual function (International Index of Erectile Function [IIEF-5]) and in the Peyronie Disease Questionnaire (PDQ) and its sub-scores, PDQ-PS (psychological symptoms), PDQ-PP (penile pain) and PDQ-BD (bother disease).

resultsOverall, 74 patients were enrolled. Mean penile curvature at baseline was 41.1° ± 12.2°. The mean changes before and at the 3-month evaluation in terms of penile curvature, Visual Analog Scale score at rest, and Visual Analog Scale score during intercourse were - 19.3 ± 8.4 (p < 0.0001), - 0.8 ± 1.1 (p < 0.0001) and - 3.8 ± 0.9 (p < 0.0001) with the benefit persisting also after 6 months. Moreover, improvements of mean IIEF-5 score (1.1 ± 0.9, p = 0.03; 0.9 ± 0.5, p = 0.02), PDQ-PS (- 2.7 ± 2.2; - 2.5 ± 2.0, p = 0.01), PDQ-PP (- 1.2 ± 1.6; - 1.1 ± 1.2, p = 0.02) and PDQ-BD (- 3.8 ± 3.4; - 3.5 ± 3.1, p = 0.001) were observed 3 and 6 months after the end of treatment, respectively. At the multivariable regression analysis, the time since disease onset (modelled with non-linear terms) and baseline curvature were independently associated with the degree of curvature improvement (coefficient: 0.30; 95% confidence interval 0.16-0.44) after a single intralesional injection (all p < 0.03).

conclusionsAlthough intralesional therapy with collagenase Clostridium histolyticum is not yet indicated for the acute phase of Peyronie's disease, these preliminary results suggest the effectiveness of this minimally invasive option by improving penile curvature and IIEF-5 and PDQ scores.

Indexed as

Acute DiseaseAdolescentAdultAgedCollagenasesDisease ProgressionHathewaya histolyticaHumansInjections, IntralesionalMaleMiddle AgedPainPenile IndurationSurveys and QuestionnairesTreatment OutcomeCollagenasesxiapex

Identifiers

PMID32342279
OpenAlexW3018090613

What OpenQuestion holds

Textmetadata
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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.