Analysis of Technique Comparison With a Vacuum Erection Device as Part of an Erectile Rehabilitation Program Following Robotic Radical Prostatectomy: A Randomized Comparison of Methodology
N/A
70 Years
Male
Male Erectile Disorder, Prostate Cancer, Sexual Dysfunction
Trial Information
Analysis of Technique Comparison With a Vacuum Erection Device as Part of an Erectile Rehabilitation Program Following Robotic Radical Prostatectomy: A Randomized Comparison of Methodology
PRIMARY OBJECTIVES:
I. Determine sexual function and penile morphometric outcomes for the post-robotic-assisted
laparoscopic prostatectomy (RALP) patients undergoing daily vacuum therapy using one of two
randomized methods and whether these outcomes differ.
SECONDARY OBJECTIVES:
I. Compare compliance rates between the two randomized groups using the compliance
questionnaire and a diary collected from patients at each follow up visit.
II. Compare overall patient satisfaction with the recovery procedure between the two
randomized groups utilizing the SHIM (Sexual Health Inventory for Men) questionnaire.
OUTLINE: Patients are randomized to 1 of 2 treatment groups.
GROUP A: Patients receive vacuum therapy daily over 10 minutes while holding erection for 2
minutes after undergoing RALP. Patients complete erection process 5 times.
GROUP B: Patients receive vacuum therapy daily over 10 minutes while holding erection for 5
minutes after undergoing RALP. Patients complete erection process 2 times.
After completion of study treatment, patients are followed up at 3, 6, and 12 months.
Inclusion Criteria:
- Sexually active men without the consistent use of erectile aids pre-operatively (i.e.
oral pharmacotherapy, intraurethral prostoglandin E1 [PGE1], intracavernosal
injection therapy and penile implants)
- Undergoing a bilateral nerve sparing robotic prostatectomy
- Pre-operative baseline SHIM total score of greater than or equal to 17
- Presence of a female sexual partner
- Dexterity necessary to operate vacuum pump
Exclusion Criteria:
- Has a history of cardiac failure, angina, or life-threatening arrhythmia within the
past 6 months
- Has taken or has been prescribed nitrate medication in any form in the last 6 months
- Has a known sensitivity to Phosphodiesterase type 5 inhibitors such as Sildenafil,
Tadalafil or Vardenafil
- Men with sickle cell anemia
- Men with insufficient manual dexterity to operate vacuum device
- Men with a history of known penile deformity or Peyronie's disease
- Pre or postoperative androgen therapy
- Pre or postoperative radiation therapy to pelvic area
- Men actively smoking at time of enrollment, 1 pack per day or more
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Changes in sexual function based on the self reported SHIM assessment and penile morphometric outcomes based on penile dimension measurements at rest
Outcome Description:
Summarized according to assigned treatment group. Linear mixed models will be used to model the changes over time.
Outcome Time Frame:
3 months post-surgery
Safety Issue:
No
Principal Investigator
Ronney Abaza, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Ohio State University
Authority:
United States: Institutional Review Board
Study ID:
OSU-11019
NCT ID:
NCT01660152
Start Date:
September 2011
Completion Date:
Related Keywords:
- Male Erectile Disorder
- Prostate Cancer
- Sexual Dysfunction
- male erectile disorder
- prostate cancer
- Laparoscopic prostatectomy
- Prostatic Neoplasms
- Sexual Dysfunctions, Psychological
- Erectile Dysfunction
Name | Location |
|---|---|
| Ohio State University Medical Center | Columbus, Ohio 43210 |
