Korean J Urol.  2003 Jul;44(7):702-707.

Multicenter Study on the Efficacy and Safety of Intracavernous 'TM' (Standro(R)) for the Treatment of Erectile Dysfunction in Korean

Affiliations
  • 1Department of Urology, Chung-Ang University, Korea. saeckim@unitel.co.kr
  • 2Department of Urology, Hanyang University, Korea.
  • 3Department of Urology, Seoul National University, Korea.
  • 4Department of Urology, Yonsei University, Korea.
  • 5Department of Urology, Korea University, Korea.
  • 6Department of Urology, Yeungnam University, Korea.
  • 7Department of Urology, Chonnam National University, Korea.
  • 8Department of Urology, Pusan National University, Korea.
  • 9Department of Urology, Chonbuk National University, Korea.
  • 10Department of Urology, Catholic University, Korea.
  • 11Department of Urology, Inha University,korea.
  • 12Department of Urology,Ulsan University, Korea.
  • 13Department of Urology, Sungkyunkwan University, Korea.
  • 14Department of Urology, Dong-A University, Korea.
  • 15Department of Preventive Medicine, Catholic University, Korea.

Abstract

PURPOSE: To evaluate the efficacy and safety of an intracavernous injection of lyophilized papaverine/phentolamine/alprostadil (Standro(R)) for the treatment of erectile dysfunction (ED) in Koreans.
MATERIALS AND METHODS
249 men (>20 years old), with ED (>6 month duration), were enrolled from 14 clinical centers. The intracavernous 'TMs' were titrated in a stepwise fashion at the clinic, from 0.05-0.25ml (17.64mg papaverine, 0.6mg phentolamine, and 6mug alprostadil per ml), with increment of 0.02-0.05ml, according to the etiology and severity of the ED and the patients' ages.
RESULTS
Of the 249 men, 238 completed the dose titration, and progressed to home treatment of 3 months duration. Of these 238, 193 (psychogenic 13.0%, organic 75.5%, mixed 11.5%) completed the home treatment (4 or more self-injections), with the other 45 dropping out (lost to follow-up in 24, patient refusal in 9, no chance to have intercourse in 7 and omitted recording of patient diary in 2). The success rate per trial (a total number of sufficient erection for vaginal intromission/a total number of injections) and per patient (number of patients who had one or more sufficient erections for vaginal intromission/the enrolled patients at beginning or 193 patients), and the satisfaction rate per patient (number of patients who had both patient and partner satisfaction with erection/193 patients) were 74.1, or 91.2 and 75.1%, respectively. The adverse reactions were prolonged erections in 3, urethral pain in 1 and penile skin edema in 2. Three patients complained of penile pain during an erection, but there was no dropout due to the pain. No significant changes in laboratory tests were found after the home treatment.
CONCLUSIONS
A 'TM' seems to be effective and safe for an intracavernous injection for the treatment of men with erectile dysfunction.

Keyword

Papaverine; Phentolamine; Alprostadil; Impotence

MeSH Terms

Alprostadil
Disulfiram
Edema
Erectile Dysfunction*
Follow-Up Studies
Humans
Male
Papaverine
Patient Dropouts
Phentolamine
Skin
Alprostadil
Disulfiram
Papaverine
Phentolamine
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