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

Primary Purpose

Male Erectile Disorder, Prostate Cancer, Sexual Dysfunction

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Sexual Health Inventory for Men (SHIM) questionnaire administration

management of therapy complications

Daily vacuum therapy

About this trial

This is an interventional supportive care trial for Male Erectile Disorder focused on measuring male erectile disorder, prostate cancer, Laparoscopic prostatectomy

Eligibility Criteria

undefined - 70 Years (Child, Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

Ohio State University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

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

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

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

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.

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01660152

First Posted

August 6, 2012

Last Updated

April 12, 2017

Sponsor

Ohio State University Comprehensive Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT01660152

Brief Title

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

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

September 2011 (undefined)

Primary Completion Date

July 17, 2013 (Actual)

Study Completion Date

July 17, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ohio State University Comprehensive Cancer Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Male Erectile Disorder, Prostate Cancer, Sexual Dysfunction

Keywords

male erectile disorder, prostate cancer, Laparoscopic prostatectomy

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm Description

Arm Title

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

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Sexual Health Inventory for Men (SHIM) questionnaire administration

Other Intervention Name(s)

assessment

Intervention Description

Questionnaire will be completed prior to surgery and at 3, 6, 12 months and the compliance questionnaire at 3, 6, 12 months.

Intervention Type

Procedure

Intervention Name(s)

management of therapy complications

Other Intervention Name(s)

complications of therapy, management of

Intervention Description

Receive VED

Intervention Type

Procedure

Intervention Name(s)

Daily vacuum therapy

Intervention Description

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.

Primary Outcome Measure Information:

Title

Changes in sexual function based on the self reported SHIM assessment and penile morphometric outcomes based on penile dimension measurements at rest

Description

Summarized according to assigned treatment group. Linear mixed models will be used to model the changes over time.

Time Frame

3 months post-surgery

Title

Changes in sexual function based on the self reported SHIM assessment and penile morphometric outcomes based on penile dimension measurements at rest

Description

Summarized according to assigned treatment group. Linear mixed models will be used to model the changes over time.

Time Frame

6 months post-surgery

Title

Changes in sexual function based on the self reported SHIM assessment and penile morphometric outcomes based on penile dimension measurements at rest

Description

Summarized according to assigned treatment group. Linear mixed models will be used to model the changes over time.

Time Frame

12 months post-surgery

Secondary Outcome Measure Information:

Title

Compliance and overall patient satisfaction (1 to 25 point scale) based on the self reported compliance diary and SHIM questionnaires

Description

Summarized according to assigned treatment group.

Time Frame

Up to 12 months post-surgery

10. Eligibility

Sex

Male

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ronney Abaza, MD

Organizational Affiliation

Ohio State University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ohio State University Medical Center

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

12. IPD Sharing Statement

Links:

URL

http://cancer.osu.edu

Description

Jamesline

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

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