Early Start of Oral Sildenafil 100mg for Erectile Dysfunction After Robotic Assisted Laparoscopic Radical Prostatectomy (SILRALP)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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 ]
- 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 |
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| 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 | |
| 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 | |
| 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 Neoplasms Erectile Dysfunction Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases 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 |
ClinicalTrials.gov processed this record on June 18, 2013