NCT01054001

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
124

participants targeted

Target at P50-P75 for not_applicable prostate-cancer

Timeline
Completed

Started Jun 2010

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 22, 2010

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

August 22, 2011

Status Verified

August 1, 2011

Enrollment Period

2.5 years

First QC Date

January 21, 2010

Last Update Submit

August 18, 2011

Conditions

Prostate Cancer

Keywords

prostate cancerprostatectomyerectile dysfunction

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Study Arms (2)

Early

ACTIVE COMPARATOR

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

Drug: sildenafil 100mg

Delayed

ACTIVE COMPARATOR

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

Drug: sildenafil 100mg

Interventions

sildenafil 100mgDRUG

sildenafil 100mg per oral twice a week

Also known as: Viagra 100mg
DelayedEarly

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam, Gyeonggido, 463-707, South Korea

RECRUITING

MeSH Terms

Conditions

Prostatic NeoplasmsErectile Dysfunction

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesSexual Dysfunction, PhysiologicalSexual Dysfunctions, PsychologicalMental Disorders

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Sang Eun Lee, Professor

    Seoul National University Bundang Hospital

    STUDY CHAIR

Central Study Contacts

Sang Eun SE Lee, Professor

CONTACT

82-31-787-7349urojsj@empal.com

Seong Jin SJ Jeong, Professor

CONTACT

82-31-787-7349urojsj@empal.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 21, 2010

First Posted

January 22, 2010

Study Start

June 1, 2010

Primary Completion

December 1, 2012

Study Completion

January 1, 2013

Last Updated

August 22, 2011

Record last verified: 2011-08

Locations

KR(1)