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Penile Length Maintenance Post-Prostatectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03500419
Recruitment Status : Completed
First Posted : April 18, 2018
Results First Posted : October 20, 2021
Last Update Posted : October 20, 2021
Sponsor:
Information provided by (Responsible Party):
Matthew (Matt) J. Ziegelmann, Mayo Clinic

Brief Summary:
The objective of the current study is to evaluate the efficacy of a novel, class I (ie. lowest risk, clinical studies not required) medical penile traction device in preventing loss of penile length in men undergoing robotic-assisted prostatectomy.

Condition or disease Intervention/treatment Phase
Prostate Cancer Penile Diseases Device: RestoreX Other: No treatment Not Applicable

Detailed Description:

The treatment of prostate cancer results in several known sexual dysfunctions, including erectile dysfunction, orgasmic dysfunction, ejaculatory dysfunction, penile curvature (Peyronie's disease), and reduced penile length. Among the dysfunctions, loss of penile length is often one that results in significant distress and bother to patients. Beyond the esthetic concerns, reduced penile length may lead to inability to participate in sexual intercourse, difficulty with future interventions to restore erectile function, and lead to worsened urinary hygiene.

Penile traction therapy (PTT) is currently the best available treatment to maintain or restore lost penile length due to conditions that reduce length. To date, no studies have evaluated the benefits of using PTT in this clinical setting. The objective of the current study is to evaluate the efficacy of a novel penile traction device (RestoreX®), created and funded through Mayo Ventures, in maintaining or restoring reduced penile length.

To accomplish the study, a population of men from Mayo Clinic who have undergone a prostatectomy will be enrolled and randomized to utilize the device for varying amounts of time. Outcomes will be assessed at 6 and 9 months post-prostatectomy and results are to be used with the intent to publish in a scientific journal.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Penile Length Maintenance Post-Prostatectomy
Actual Study Start Date : March 23, 2018
Actual Primary Completion Date : December 28, 2020
Actual Study Completion Date : December 28, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Control
No treatment will be administered for the initial 6 months post-prostatectomy. This is necessary as a measure to review post-prostatectomy penile length changes.
Other: No treatment
Control group. No treatment will be given for the 6 months post-prostatectomy

Experimental: Group AB - PTT 1-2x daily x 5-7 days/week x 5 months
Men will utilize penile traction therapy for 30 minutes 1-2 times daily, 5-7 times a week, beginning 4 weeks post-prostatectomy. Men will remain in this phase for a period of 5 months.
Device: RestoreX
PTT - Penile traction therapy in the straight position.




Primary Outcome Measures :
  1. Change in Penile Length [ Time Frame: Baseline, 6 months ]
    Stretched penile length measured in centimeters from pubic symphysis to glanular corona


Secondary Outcome Measures :
  1. Erectogenic Therapy Use [ Time Frame: 6 months ]
    The percentage of subjects to use a phosphodiesterase-5 inhibitor for erectogenic therapy use

  2. Intracavernosal Injections [ Time Frame: 6 months ]
    The percentage of subjects to use intracavernosal injections

  3. Change in Erectile Function Domain of International Index of Erectile Function (IIEF) [ Time Frame: baseline, 6 months ]
    Erectile function domain will be measured by using the International Index of Erectile Function (IIEF) questionnaire. IIEF is a validated, 15-item questionnaire that assesses 5 domains of sexual function: erectile function (range 1-30), orgasmic function (range 0-10), sexual desire (range 2-10), intercourse satisfaction (range 0-15), and overall sexual satisfaction (range 2-10). Each question was answered on a 6-point or 5-point scale from 0/1 to 5 (best) with a total possible score (sum of 5 domains) range of 5 to 75 with higher scores representing better function.

  4. Change in Intercourse Satisfaction Domain of International Index of Erectile Function (IIEF) [ Time Frame: Baseline, 6 months ]
    Intercourse satisfaction will be measured by using the International Index of Erectile Function (IIEF) questionnaire. IIEF is a validated, 15-item questionnaire that assesses 5 domains of sexual function: erectile function (range 1-30), orgasmic function (range 0-10), sexual desire (range 2-10), intercourse satisfaction (range 0-15), and overall sexual satisfaction (range 2-10). Each question was answered on a 6-point or 5-point scale from 0/1 to 5 (best) with a total possible score (sum of 5 domains) range of 5 to 75 with higher scores representing better function.

  5. Change in Overall Satisfaction Domain of International Index of Erectile Function (IIEF) [ Time Frame: Baseline, 6 months ]
    Overall satisfaction domain will be measured by using the International Index of Erectile Function (IIEF) questionnaire. IIEF is a validated, 15-item questionnaire that assesses 5 domains of sexual function: erectile function (range 1-30), orgasmic function (range 0-10), sexual desire (range 2-10), intercourse satisfaction (range 0-15), and overall sexual satisfaction (range 2-10). Each question was answered on a 6-point or 5-point scale from 0/1 to 5 (best) with a total possible score (sum of 5 domains) range of 5 to 75 with higher scores representing better function.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Undergoing robotic prostatectomy
  • Seen in the post-prostatectomy rehab clinic

Exclusion Criteria:

• Urethral complications from prostatectomy at the time of baseline visit


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03500419


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Matthew Ziegelmann, MD Mayo Clinic
  Study Documents (Full-Text)

Documents provided by Matthew (Matt) J. Ziegelmann, Mayo Clinic:
Additional Information:
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Responsible Party: Matthew (Matt) J. Ziegelmann, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03500419    
Other Study ID Numbers: 18-001013
First Posted: April 18, 2018    Key Record Dates
Results First Posted: October 20, 2021
Last Update Posted: October 20, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Penile Diseases