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
  Purpose

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).


Condition Intervention
Prostate Cancer
Drug: sildenafil 100mg

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Early Start of Oral Sildenafil 100mg for Erectile Dysfunction After Robotic Assisted Laparoscopic Radical Prostatectomy

Resource links provided by NLM:


Further study details as provided by Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 124
Study Start Date: June 2010
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Early
men with on- demand sildenafil 100mg dosing from the early postoperative period
Drug: sildenafil 100mg
sildenafil 100mg per oral twice a week
Other Name: Viagra 100mg
Active Comparator: Delayed
men with on- demand sildenafil 100mg dosing from the delayed postoperative period
Drug: sildenafil 100mg
sildenafil 100mg per oral twice a week
Other Name: Viagra 100mg

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01054001

Contacts
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

Locations
Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam, Gyeonggido, Korea, Republic of, 463-707
Contact: Sang Eun Lee, Professor    82-31-787-7349    urojsj@empal.com   
Contact: Seong Jin Jeong, Professor    82-31-787-7349    urojsj@empal.com   
Principal Investigator: Sang Eun Lee, Professor         
Sponsors and Collaborators
Seoul National University Bundang Hospital
Pfizer
Investigators
Study Chair: Sang Eun Lee, Professor Seoul National University Bundang Hospital
  More Information

No publications provided

Responsible Party: Sang Eun Lee, Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01054001     History of Changes
Other Study ID Numbers: WS486539
Study First Received: January 21, 2010
Last Updated: August 18, 2011
Health Authority: Korea: Institutional Review Board

Keywords provided by Seoul National University Bundang Hospital:
prostate cancer
prostatectomy
erectile dysfunction

Additional relevant MeSH terms:
Prostatic Diseases
Prostatic Neoplasms
Erectile Dysfunction
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Sildenafil
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents

ClinicalTrials.gov processed this record on August 20, 2014