Clinical efficacy, safety and tolerability of collagenase clostridium histolyticum for the treatment of peyronie disease in 2 large double-blind, randomized, placebo controlled phase 3 studies.

@article{Gelbard2013ClinicalES,
  title={Clinical efficacy, safety and tolerability of collagenase clostridium histolyticum for the treatment of peyronie disease in 2 large double-blind, randomized, placebo controlled phase 3 studies.},
  author={M. Gelbard and I. Goldstein and W. Hellstrom and C. Mcmahon and Ted M Smith and J. Tursi and Nigel Jones and G. Kaufman and C. Carson},
  journal={The Journal of urology},
  year={2013},
  volume={190 1},
  pages={
          199-207
        }
}
PURPOSE IMPRESS (Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies) I and II examined the clinical efficacy and safety of collagenase Clostridium histolyticum intralesional injections in subjects with Peyronie disease. Co-primary outcomes in these identical phase 3 randomized, double-blind, placebo controlled studies included the percent change in the penile curvature abnormality and the change in the Peyronie disease questionnaire symptom bother score from baseline to… Expand
Clinical safety and effectiveness of collagenase clostridium histolyticum injection in patients with Peyronie's disease: a phase 3 open-label study.
TLDR
Potentially clinically meaningful and statistically significant improvements in penile curvature deformity and PD symptom bother scores were observed with intralesional injection of CCH compared with baseline in men with PD. Expand
ORIGINAL RESEARCH—PEYRONIE'S DISEASE Clinical Safety and Effectiveness of Collagenase Clostridium Histolyticum Injection in Patients with Peyronie's Disease: A Phase 3 Open-Label Study
TLDR
Potentially clinically meaningful and statistically significant improvements in penile curvature defor- mity and PD symptom bother scores were observed with intralesional injection of CCH compared with baseline in men with PD. Expand
Re: Limited success with clostridium collagenase histolyticum following FDA approval for the treatment of Peyronie’s disease
TLDR
CCH appears to be substantially less effective than in previously published reports, and the need for identifying ideal patients that will respond to CCH is highlighted, as well as some guidance on predicting outcomes. Expand
Safety and Efficacy Study of Collagenase Clostridium Histolyticum Applied With an Intensive Protocol in the Treatment of Peyronie's Disease
TLDR
The safety and efficacy of CCH in the treatment of Peyronie's disease is demonstrated using a more intense protocol than the previous ones, and reducing the overall duration allows for greater adherence and compliance of patients. Expand
Changes in the Effects of Peyronie's Disease After Treatment With Collagenase Clostridium histolyticum: Male Patients and Their Female Partners
TLDR
The results support the safety and efficacy of CCH in the management of appropriate patients with PD and the potential benefits for patients' partners. Expand
A state-of-art review on collagenase Clostridium Histolyticum and Peyronie’s disease: drug profile, clinical evidence and safety outcomes
TLDR
Given the variability in treatment schedule and drug access coupled with the potential need for further treatment, strict patient selection and the use of adjunctive strategies are key determinants to maximize clinical efficacy of intralesional CCH. Expand
Treatment of Peyronie's Disease With Collagenase Clostridium histolyticum and Vacuum Therapy: A Randomized, Open-Label Pilot Study.
TLDR
Improvements in most PDQ domains, including bother, were observed from baseline to week 36 in the two groups and CCH and vacuum-pump therapy (alone or combined with modeling) could be an appropriate consideration for men with PD and warrants further investigation. Expand
Editorial Comment on ‘Limited success with Clostridium Collagenase Histolyticum following FDA approval for the treatment of Peyronie’s disease’
  • R. Tal
  • Medicine
  • International Journal of Impotence Research
  • 2018
TLDR
The findings of the present study are quite surprising: overall a minimal and statistically insignificant curvature reduction, and ultimately high rate of dissatisfaction. Expand
Safety and Efficacy of Collagenase Clostridium histolyticum in the Treatment of Acute-Phase Peyronie's Disease.
TLDR
The first report that assesses the safety and efficacy of CCH therapy focusing on acute-phase Peyronie's disease suggests that CCH use during this phase can be effective and safe. Expand
Topical treatment for acute phase Peyronie’s disease utilizing a new gel, H-100: a randomized, prospective, placebo-controlled pilot study
Safety and efficacy of topically applied gel H-100 composed of Nicardipine, superoxide dismutase and emu oil for treatment of acute phase Peyronie’s disease (PD) was evaluated. Twenty-two patientsExpand
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References

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Phase 2b study of the clinical efficacy and safety of collagenase Clostridium histolyticum in patients with Peyronie disease.
TLDR
A significant improvement in penile curvature was noted and patient reported outcome symptom bother scores were observed, suggesting that this may be a safe, nonsurgical alternative for Peyronie disease. Expand
The use of intralesional clostridial collagenase injection therapy for Peyronie's disease: a prospective, single-center, non-placebo-controlled study.
  • G. Jordan
  • Medicine
  • The journal of sexual medicine
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TLDR
The benefits of intralesional clostridial collagenase injections in this trial lend support to prior studies supporting its use in the management of Peyronie's disease. Expand
Injectable collagenase clostridium histolyticum for Dupuytren's contracture.
TLDR
Collagenase clostridium histolyticum significantly reduced contractures and improved the range of motion in joints affected by advanced Dupuytren's disease. Expand
Collagenase for Peyronie's disease experimental studies
TLDR
It is concluded that collagenase may warrant further clinical testing in the treatment of Peyronie's disease and its effects on plaques, blood vessels, and nerves in vivo and in vitro. Expand
Collagenase versus placebo in the treatment of Peyronie's disease: a double-blind study.
TLDR
For the group as a whole, treatment out-performed placebo (p < 0.007), and when patients were analyzed with respect to disease severity, those with lesser deformity responded more favorably to treatment. Expand
Systematic evidence-based analysis of plaque injection therapy for Peyronie's disease.
TLDR
Ninety percent of the studies regarding Peyronie's disease showed positive outcomes, but most of these have not offered convincing evidence-based data, with only one positive study meeting level 1 Oxford criteria for clinical efficacy. Expand
Peyronie's disease intervention trials: methodological challenges and issues.
TLDR
A comprehensive review of the current literature on nonsurgical treatment options for Peyronie's Disease was conducted to address methodological issues and challenges in PD trials highlighting trial design, patient population, and symptom and sign assessment. Expand
Five-year follow-up of Peyronie's graft surgery: outcomes and patient satisfaction.
TLDR
The recurrence of penile curvature, penile length loss, and the new-onset of ED are not uncommon sequelae and are associated with a significant patient dissatisfaction rate when a 5-year follow-up is achieved. Expand
Surgical correction of Peyronie's disease via tunica albuginea plication or partial plaque excision with pericardial graft: long-term follow up.
TLDR
The long-term results support both TAP and PEG as durable surgical therapy for men with clinically significant PD. Expand
The management of Peyronie's disease: evidence-based 2010 guidelines.
TLDR
The real etiology of Peyronie's disease and the mechanisms of formation of the plaque still remain obscure, and conservative management is obtaining a progressively larger consensus among the experts. Expand
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