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

Primary Purpose

Prostate Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
sildenafil 100mg
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring prostate cancer, prostatectomy, erectile dysfunction

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Seoul National University Bundang HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Early

Delayed

Arm Description

men with on- demand sildenafil 100mg dosing from the early postoperative period

men with on- demand sildenafil 100mg dosing from the delayed postoperative period

Outcomes

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)

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

Full Information

First Posted
January 21, 2010
Last Updated
August 18, 2011
Sponsor
Seoul National University Bundang Hospital
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01054001
Brief Title
Early Start of Oral Sildenafil 100mg for Erectile Dysfunction After Robotic Assisted Laparoscopic Radical Prostatectomy
Acronym
SILRALP
Official Title
Early Start of Oral Sildenafil 100mg for Erectile Dysfunction After Robotic Assisted Laparoscopic Radical Prostatectomy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Unknown status
Study Start Date
June 2010 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
January 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
prostate cancer, prostatectomy, erectile dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
124 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early
Arm Type
Active Comparator
Arm Description
men with on- demand sildenafil 100mg dosing from the early postoperative period
Arm Title
Delayed
Arm Type
Active Comparator
Arm Description
men with on- demand sildenafil 100mg dosing from the delayed postoperative period
Intervention Type
Drug
Intervention Name(s)
sildenafil 100mg
Other Intervention Name(s)
Viagra 100mg
Intervention Description
sildenafil 100mg per oral twice a week
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sang Eun SE Lee, Professor
Phone
82-31-787-7349
Email
urojsj@empal.com
First Name & Middle Initial & Last Name or Official Title & Degree
Seong Jin SJ Jeong, Professor
Phone
82-31-787-7349
Email
urojsj@empal.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sang Eun Lee, Professor
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyeonggido
ZIP/Postal Code
463-707
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang Eun Lee, Professor
Phone
82-31-787-7349
Email
urojsj@empal.com
First Name & Middle Initial & Last Name & Degree
Seong Jin Jeong, Professor
Phone
82-31-787-7349
Email
urojsj@empal.com
First Name & Middle Initial & Last Name & Degree
Sang Eun Lee, Professor

12. IPD Sharing Statement

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

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