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Penile Lengthening Pre-Penile Prosthesis Implantation

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ClinicalTrials.gov Identifier: NCT03500406
Recruitment Status : Recruiting
First Posted : April 17, 2018
Last Update Posted : January 1, 2019
Sponsor:
Information provided by (Responsible Party):
Landon W. Trost, Mayo Clinic

Brief Summary:
This study is intended to utilize a novel, class I (ie. lowest risk, clinical studies not required) medical device to determine whether penile length can be increased in men prior to undergoing a penile prosthesis implantation procedure.

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Device: RestoreX Other: Control Not Applicable

Detailed Description:

Men with erectile dysfunction, unresponsive to conservative therapies, are recommended to undergo placement of an inflatable penile prosthesis (IPP); however, it is a common complaint post-operatively that their penis length is shorter than what it was previously.

Several attempts have been made by investigators to optimize penile length prior to placement of the penile prosthesis. Compared to other options, penile traction therapy (PTT) offers several potential advantages in that it is minimally-invasive, does not increase the morbidity of surgery, and has not been shown to result in any long-term side effects.

A new penile traction device (RestoreX® ) was created and funded through Mayo Ventures. Given the clinical issue of dissatisfaction with penile length post IPP, the potential role for PTT, and limited amount of data available, we sought to perform a clinical trial evaluating the effect of PTT on increasing the total length of prosthesis which can be inserted. We additionally sought to determine if PTT resulted in improved post-operative satisfaction on total penile length achieved.

To accomplish the study, a population of men from Mayo Clinic planning to undergo placement of an IPP will be enrolled and given the option to either join the control (no treatment) group or PTT group for 3 months prior to their procedure. Outcomes will be assessed prior to surgery and 3, 6, and 12 months post-procedure. Results are to be used with the intent to publish in a scientific journal.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Penile Lengthening Pre-Penile Prosthesis Implantation
Actual Study Start Date : March 23, 2018
Estimated Primary Completion Date : March 23, 2021
Estimated Study Completion Date : March 23, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Artificial Limbs

Arm Intervention/treatment
Sham Comparator: Group 1 - Control
No treatment will be administered and men will not have to delay their IPP procedure
Other: Control
No treatment

Experimental: Group 2 - PTT 3x daily x 3 months
Men will utilize penile traction therapy for 30 minutes three times daily for the 3 months prior to placement of their IPP
Device: RestoreX
Penile traction therapy in the straight position




Primary Outcome Measures :
  1. Length Assessment of Penile Prosthesis Implanted [ Time Frame: From baseline to 3 months ]
    The primary objective is to assess the length of the penile prosthesis inserted into subjects following completion of RestoreX® traction therapy compared to the control group (no treatment)


Secondary Outcome Measures :
  1. Participant Compliance [ Time Frame: From baseline to 3 months ]
    Compare Participant compliance with traction device

  2. Participant Satisfaction with Traction [ Time Frame: From baseline to 3 months ]
    Compare patient reported satisfaction with use of traction device

  3. Adverse Events with use of Traction [ Time Frame: From baseline to 3 months ]
    Evaluate any adverse events with use of RestoreX® for penile lengthening.

  4. Operative Complications [ Time Frame: 3, 6, 12 months post-operative ]
    Compare intra- and/or post-operative complication rates.

  5. Stretched Penile Length [ Time Frame: From baseline to 12 months ]
    Compare pre- and post-operative stretched penile lengths

  6. Participant Satisfaction Penile Length [ Time Frame: Baseline to 12 months post-operative ]
    Compare participant satisfaction scores including satisfaction with overall penile length



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

  • Men undergoing placement of a penile prosthesis
  • Must be the first time a penile prosthesis is implanted
  • Undergoing implantation of a 3-piece inflatable penile prosthesis

Exclusion Criteria

  • Prior ischemic priapism
  • Any prior penile prosthesis surgeries
  • Any prior penile surgeries other than circumcision
  • Undergoing malleable penile prosthesis or Ambicor device

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): NCT03500406


Locations
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United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Brett Milazzo    507-538-6151    milazzo.brett@mayo.edu   
United States, Missouri
Washington University School of Medicine Not yet recruiting
Saint Louis, Missouri, United States, 63110
Contact: Yifen Meng    314-574-7366    ymeng@wustl.edu   
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Landon W Trost Mayo Clinic
  Study Documents (Full-Text)

Documents provided by Landon W. Trost, Mayo Clinic:

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Responsible Party: Landon W. Trost, Consultant, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03500406     History of Changes
Other Study ID Numbers: 17-011052
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: January 1, 2019
Last Verified: December 2018
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
Device Product Not Approved or Cleared by U.S. FDA: No

Additional relevant MeSH terms:
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Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders