Early Start of Oral Sildenafil 100mg for Erectile Dysfunction After Robotic Assisted Laparoscopic Radical Prostatectomy (SILRALP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Seoul National University Bundang Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Sang Eun Lee, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT01054001
First received: January 21, 2010
Last updated: August 18, 2011
Last verified: August 2011

January 21, 2010
August 18, 2011
June 2010
December 2012   (final data collection date for primary outcome measure)
patterns of recovery of erectile functions after nerve sparing RALP in men with on- demand sildenafil 100mg dosing from the early postoperative period (using IIEF-5) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01054001 on ClinicalTrials.gov Archive Site
comparison of the potency rates in men with on- demand sildenafil 100mg dosing from the early postoperative period with from the delayed postoperative period [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Early Start of Oral Sildenafil 100mg for Erectile Dysfunction After Robotic Assisted Laparoscopic Radical Prostatectomy
Early Start of Oral Sildenafil 100mg for Erectile Dysfunction After Robotic Assisted Laparoscopic Radical Prostatectomy

The investigators try to investigate the benefit of early administration (immediately after urethral catheter removal) of sildenafil after nerve-sparing RALP for 3 months. The investigators will compare the potency rates up to 2 years after nerve-sparing RALP in men with on- demand sildenafil 100mg dosing from the early postoperative period (immediately after urethral catheter removal) with from the delayed postoperative period (3 months after RP).

Various studies using animal models of CN neuroparaxia and clinical trials have demonstrated somewhat beneficial effect of PDE-5 inhibitors on smooth muscle cells of the corpus cavernosum. PDE-5 inhibitors including sildenafil have demonstrated the effectiveness in the management of postprostatectomy ED. In the animal experiments, PDE-5 inhibitors lowered the severity of the fibrosis in the corpus cavernosum of rats with CN cutting. In the clinical trials, on-demand dosing or routine dosing of PDE-5 inhibitors improved the potency rates in men received NSRP, and improvements of the potency rate did not appear to be statistically different among two dosing regimens.

But, there are few studies on the potency rate according to the start time of the administration of PDE-5 inhibitors (eg. early vs. delayed post-operative dosing). At present, it is not conclusive that whether nerve-sparing RALP provides more higher potency rate than conventional surgery in men with prostate cancers. But, with more precise dissection of CN, the robotic surgery appears to have more chances to maintain the potency in men received RP.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
Drug: sildenafil 100mg
sildenafil 100mg per oral twice a week
Other Name: Viagra 100mg
  • Active Comparator: Early
    men with on- demand sildenafil 100mg dosing from the early postoperative period
    Intervention: Drug: sildenafil 100mg
  • Active Comparator: Delayed
    men with on- demand sildenafil 100mg dosing from the delayed postoperative period
    Intervention: Drug: sildenafil 100mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
124
January 2013
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with agree to participate with the study
  • Korean male subjects aged 50 years or older with clinically localized prostate cancer
  • Preoperative potent men (IIEF-5 score 17 or more than 17)
  • Patients in a stable, heterosexual relationship with a single partner for at least the past six months
  • Suitable for nerve sparing indication

Exclusion Criteria:

  • Genital anatomical deformities that would significantly impair erection
  • Other sexual disorders (e.g. hypoactive sexual desire) that are considered to be the primary diagnosis when there is a coexisting diagnosis of erectile dysfunction.
  • Known raised prolactin level (>3 times the upper limit of the normal range) or low free testosterone level (confirmed to be >20% below the lower limit of the normal range on blood collected between 09:00 and 11:00 hours).
  • Major psychiatric disorder (including major depression or schizophrenia) that is not well controlled on treatment.
Male
Not Provided
No
Contact: Sang Eun SE Lee, Professor 82-31-787-7349 urojsj@empal.com
Contact: Seong Jin SJ Jeong, Professor 82-31-787-7349 urojsj@empal.com
Korea, Republic of
 
NCT01054001
WS486539
Yes
Sang Eun Lee, Seoul National University Bundang Hospital
Seoul National University Bundang Hospital
Pfizer
Study Chair: Sang Eun Lee, Professor Seoul National University Bundang Hospital
Seoul National University Bundang Hospital
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP