Male Erectile DisorderNCT01660152
Vacuum Erection Device in Improving Recovery of Erectile Function in Patients With Prostate Cancer Undergoing Surgery
A study testing Sexual Health Inventory for Men (SHIM) questionnaire administration, management of therapy complications and Daily vacuum therapy in people with Male Erectile Disorder and Prostate Cancer, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 70 years, men only
- Conditions the study is for
- Male Erectile Disorder, Prostate Cancer, Sexual Dysfunction
- What is being tested?
- Sexual Health Inventory for Men (SHIM) questionnaire administration, management of therapy complications and Daily vacuum therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to 17 Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 70 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Medical Center
Columbus, Ohio, 43210
About this study
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
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
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Male Erectile Disorder, Prostate Cancer, Sexual Dysfunction
- Being tested
- Sexual Health Inventory for Men (SHIM) questionnaire administration, management of therapy complications, Daily vacuum therapy
- Keywords
- male erectile disorder, prostate cancer, Laparoscopic prostatectomy
- Medical subject headings
- Erectile Dysfunction, Prostatic Neoplasms, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sexual Health Inventory for Men (SHIM) questionnaire administrationOther
Also called assessment
Questionnaire will be completed prior to surgery and at 3, 6, 12 months and the compliance questionnaire at 3, 6, 12 months.
management of therapy complicationsProcedure or surgery
Also called complications of therapy, management of
Receive VED
Daily vacuum therapyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A (vacuum therapy, holding erection for 2 minutes) | Experimental | 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. Receives: Other: Sexual Health Inventory for Men (SHIM) questionnaire administration; Procedure: management of therapy complications; Procedure: Daily vacuum therapy |
| Group B (vacuum therapy, holding erection for 5 minutes) | Experimental | 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. Receives: Other: Sexual Health Inventory for Men (SHIM) questionnaire administration; Procedure: management of therapy complications; Procedure: Daily vacuum therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months post-surgery
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.
Measured: 6 months post-surgery
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.
Measured: 12 months post-surgery
Secondary outcomes (1)
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.
Measured: Up to 12 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2012 (estimated)
- Study startSep 2011
- Primary completion17 Jul 2013
- Study completion17 Jul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male Erectile DisorderStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ronney Abaza, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01660152
- Sponsor's protocol ID
- OSU-11019
- Other IDs
- NCI-2012-00997
- Status last verified
- Apr 2017
- First submitted
- 6 Aug 2012
- Last updated
- 13 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01660152
- Acronym / sponsor ID
- OSU-11019
- Conditions
- Male Erectile Disorder, Prostate Cancer, Sexual Dysfunction
- Keywords
- male erectile disorder, prostate cancer, Laparoscopic prostatectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- 17 Jul 2013 (actual)
- Study completion
- 17 Jul 2013 (actual)
- First posted
- 8 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (vacuum therapy, holding erection for 2 minutes) | Experimental | Other: Sexual Health Inventory for Men (SHIM) questionnaire administration, Procedure: management of therapy complications, Procedure: Daily vacuum therapyPatients 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. |
| Group B (vacuum therapy, holding erection for 5 minutes) | Experimental | Other: Sexual Health Inventory for Men (SHIM) questionnaire administration, Procedure: management of therapy complications, Procedure: Daily vacuum therapyPatients 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. |
Who may qualify
- Ages
- Up to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sexual Health Inventory for Men (SHIM) questionnaire administrationAlso: assessmentQuestionnaire will be completed prior to surgery and at 3, 6, 12 months and the compliance questionnaire at 3, 6, 12 months. | Other | Group A (vacuum therapy, holding erection for 2 minutes), Group B (vacuum therapy, holding erection for 5 minutes) |
| management of therapy complicationsAlso: complications of therapy, management ofReceive VED | Procedure or surgery | Group A (vacuum therapy, holding erection for 2 minutes), Group B (vacuum therapy, holding erection for 5 minutes) |
| Daily vacuum therapyPatients 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. | Procedure or surgery | Group A (vacuum therapy, holding erection for 2 minutes), Group B (vacuum therapy, holding erection for 5 minutes) |
Primary outcome
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.
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.
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2017.
- JameslineLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronney Abaza, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sexual Health Inventory for Men (SHIM) questionnaire administration, management of therapy complications and Daily vacuum therapy in people with Male Erectile Disorder and Prostate Cancer, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2017.