Improving Erectile Function and Quality of Life After Prostate Cancer Treatment

Summary

This is a research study of erectile dysfunction (ED) in men diagnosed with prostate cancer. 144 patients and partners will participate in the study. The purpose of this study is to test a new treatment that combines a cognitive-behavioral intervention with medication and a vacuum constrictive device to treat ED. This new treatment consists of multiple therapeutic elements that enhance compliance with medical treatment and increase sexual activity through enhancement of the sensual pleasure of sex and partner support.

Conditions

• Prostate Cancer
• Erectile Dysfunction Following Radical Prostatectomy
• Erectile Dysfunction Following Simple Prostatectomy
• Erectile Dysfunction

Interventions

BEHAVIORAL

Cognitive-behavioral Meetings

The cognitive-behavioral intervention will consist of six monthly in-person meetings and five telephone follow-ups. In-person meetings include a 90-minute educational group session and five 60-minute therapeutic couple-based meetings which partners are asked to attend. The telephone follow-ups last 15-30 minutes and take place two weeks after each in-person meeting. They will review progress and provide support. Each monthly meeting has a focused topic: Introduction, Guided imagery, Sensate focus, Communication and relationship issues, and Review. Homework will be assigned at the end of each meeting. Generally, participants are instructed (a) practice guided imagery daily, (b) engage in sexual activity 1-2 times/ week after sildenafil intake and (c) use the pump every day for 10min.

DRUG

sildenafil citrate

100mg of sildenafil citrate will be given twice a week to interested patients. Participants may start Sildenafil at a lower dose when needed. To increase external validity, participants will be given the choice of using Sildenafil in the study.

DEVICE

Vacuum Constriction Device

The medical treatment entails a 10-minute daily use of VCD (pump). The VCD (pump) is a FDA approved marketing product and has a brochure and DVD that explain its usage. The clinical trials unit (CTU) nurse will dispense the VCD at the drug pick-up time and document it on a Device Accountability Form. The study coordinator has received manufacturer's training and can address questions that a subject may have about VCD on site or through a phone call.

Sponsors & Collaborators

• The Cleveland Clinic

  collaborator OTHER

• University Hospitals Cleveland Medical Center

  collaborator OTHER

• Case Comprehensive Cancer Center

  lead OTHER

Principal Investigators

• Amy Zhang, MD · University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

21 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-07-31

Primary Completion

2016-08-31

Completion

2016-08-31

FDA Device

Yes

Countries

• United States

Study Locations