Clinical trial NCT01660152: Vacuum Erection Device in Improving Recovery of Erectile Function in Patients With Prostate Cancer Undergoing Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Male Erectile Disorder
Prostate Cancer
Sexual Dysfunction
Keywords: male erectile disorder
prostate cancer
Laparoscopic prostatectomy
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2012-08-08
Enrollment: 2
Sex: MALE
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine which technique in using a vacuum erection device (VED) is best. Erectile dysfunction (ED) after robotic prostate cancer surgery is a concern for both the surgeon and the patient. Recent studies have shown that beginning to use the vacuum pump on a daily basis starting with in 2-8 weeks may help prevent the start of penile shrinkage. This is a potential issue that can occur because of decreased blood flow after prostate cancer surgery. This study will allow researchers to determine and compare vacuum therapy techniques and erectile function outcomes of patients who have prostate cancer surgery

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in sexual function based on the self reported SHIM assessment and penile morphometric outcomes based on penile dimension measurements at rest
timeFrame: 3 months post-surgery
measure: Changes in sexual function based on the self reported SHIM assessment and penile morphometric outcomes based on penile dimension measurements at rest
timeFrame: 6 months post-surgery
measure: Changes in sexual function based on the self reported SHIM assessment and penile morphometric outcomes based on penile dimension measurements at rest
timeFrame: 12 months post-surgery
Secondary outcomes:
measure: Compliance and overall patient satisfaction (1 to 25 point scale) based on the self reported compliance diary and SHIM questionnaires
timeFrame: Up to 12 months post-surgery
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Ronney Abaza, MD
role: PRINCIPAL_INVESTIGATOR
References: