Vacuum Erection Device in Improving Recovery of Erectile Function in Patients With Prostate Cancer Undergoing Surgery

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01660152
• Other study ID #: OSU-11019
• Secondary ID: NCI-2012-00997
• Status: Completed
• Phase: N/A
• First received: August 6, 2012
• Last updated: April 12, 2017
• Start date: September 2011
• Est. completion date: July 17, 2013

Study information

• Verified date: April 2017
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: July 17, 2013
• Est. primary completion date: July 17, 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Erectile Dysfunction
• Male Erectile Disorder
• Prostate Cancer
• Prostatic Neoplasms
• Sexual Dysfunction

Intervention

Other:
• Sexual Health Inventory for Men (SHIM) questionnaire administration
Questionnaire will be completed prior to surgery and at 3, 6, 12 months and the compliance questionnaire at 3, 6, 12 months.

Procedure:
• management of therapy complications
Receive VED
• Daily vacuum therapy
Patients randomized to Group A or Group B following removal of catheter at first post op visit following surger. Daily vacuum therapy for approximately 10 minutes. Depending on which group randomized to erection held for 2 minutes or 5 mintues.

Locations

Country	Name	City	State
United States	Ohio State University Medical Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in sexual function based on the self reported SHIM assessment and penile morphometric outcomes based on penile dimension measurements at rest	Summarized according to assigned treatment group. Linear mixed models will be used to model the changes over time.	3 months post-surgery
Primary	Changes in sexual function based on the self reported SHIM assessment and penile morphometric outcomes based on penile dimension measurements at rest	Summarized according to assigned treatment group. Linear mixed models will be used to model the changes over time.	6 months post-surgery
Primary	Changes in sexual function based on the self reported SHIM assessment and penile morphometric outcomes based on penile dimension measurements at rest	Summarized according to assigned treatment group. Linear mixed models will be used to model the changes over time.	12 months post-surgery
Secondary	Compliance and overall patient satisfaction (1 to 25 point scale) based on the self reported compliance diary and SHIM questionnaires	Summarized according to assigned treatment group.	Up to 12 months post-surgery

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