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NCT Number: NCT01660152

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

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

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Key information

Conditions

Male Erectile Disorder Erectile Dysfunction Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Mental Disorders Neoplasms Neoplasms by Site Prostate Cancer Prostatic Diseases Prostatic Neoplasms Sexual Dysfunction Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases Urogenital Neoplasms

Age range

Up to 70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sexual Health Inventory for Men (SHIM) questionnaire administration

Other

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

Other names: assessment

management of therapy complications

Procedure

Receive VED

Other names: complications of therapy, management of

Daily vacuum therapy

Procedure

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 outcomes

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

    Time frame: 3 months post-surgery

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

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

    Time frame: 6 months post-surgery

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

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

    Time frame: 12 months post-surgery

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

Secondary outcomes

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

    Time frame: Up to 12 months post-surgery

    Summarized according to assigned treatment group.

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Aug 8, 2012
Registry last updated
Apr 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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