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

The Ohio State University

Status: Completed

Conditions: Sexual Dysfunction; Male Erectile Disorder; Prostate Cancer

Treatments: Other: Sexual Health Inventory for Men (SHIM) questionnaire administration; Procedure: management of therapy complications; Procedure: Daily vacuum therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01660152

NCI-2012-00997 (Registry Identifier)

OSU-11019

Details and patient eligibility

About

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

Full 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.

Enrollment: 2 patients

Sex: Male

Ages: Under 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2 participants in 2 patient groups

Group A (vacuum therapy, holding erection for 2 minutes)

Experimental group

Description:

Patients receive daily vacuum therapy over 10 minutes while holding erection for 2 minutes after undergoing RALP. Patients complete erection process 5 times. SHIM questionnaire administration will be completed prior to surgery and at 3, 6, 12 months and the compliance questionnaire at 3, 6, 12 months.

Treatment:

Procedure: Daily vacuum therapy

Procedure: management of therapy complications

Other: Sexual Health Inventory for Men (SHIM) questionnaire administration

Group B (vacuum therapy, holding erection for 5 minutes)

Experimental group

Description:

Patients receive daily vacuum therapy over 10 minutes while holding erection for 5 minutes after undergoing RALP. Patients complete erection process 2 times.Patients complete erection process 5 times. SHIM questionnaire administration will be completed prior to surgery and at 3, 6, 12 months and the compliance questionnaire at 3, 6, 12 months.

Treatment:

Procedure: Daily vacuum therapy

Procedure: management of therapy complications

Other: Sexual Health Inventory for Men (SHIM) questionnaire administration