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

Prostate Cancer Clinical Trial

— SILRALP  

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01054001
• Other study ID #: WS486539
• Status: Unknown status
• Phase: N/A
• First received: January 21, 2010
• Last updated: August 18, 2011
• Start date: June 2010
• Est. completion date: January 2013

Study information

• Verified date: August 2011
• Source: Seoul National University Bundang Hospital
• Contact: Sang Eun SE Lee, Professor
• Phone: 82-31-787-7349
• Email: urojsj[@]empal.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 124
• Est. completion date: January 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Erectile Dysfunction
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• sildenafil 100mg
sildenafil 100mg per oral twice a week

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggido

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital	Pfizer

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		1 year
Secondary	comparison of the potency rates in men with on- demand sildenafil 100mg dosing from the early postoperative period with from the delayed postoperative period		2 year