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Trial record 4 of 1487 for:    Recruiting, Not yet recruiting, Available Studies | "Genital Diseases, Male"

Penile Length Maintenance Post-Prostatectomy

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ClinicalTrials.gov Identifier: NCT03500419
Recruitment Status : Recruiting
First Posted : April 17, 2018
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
Landon W. Trost, 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 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Penile Length Maintenance Post-Prostatectomy
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


Arm Intervention/treatment
Sham Comparator: Group 1 - 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. After the 6 month period of time, this group will enter an open label phase where they may utilize a penile traction device if desired
Device: RestoreX
PTT - open label phase only Penile traction therapy in the straight position.

Experimental: Group 2 - PTT 1x daily x 5 days/week x 5 months
Men will utilize penile traction therapy for 30 minutes once daily, 5 times a week, beginning 4 weeks post-prostatectomy. Men will remain in this phase for a period of 5 months. After this phase is completed, they will enter an open label phase for 3 months where they may utilize the device as much or as little as desired.
Device: RestoreX
PTT - randomized and open label Penile traction therapy in the straight position.

Experimental: Group 3 - PTT 2x daily x 7 days/week x 5 months
Men will utilize penile traction therapy for 30 minutes twice daily, 7 times a week, beginning 4 weeks post-prostatectomy. Men will remain in this phase for a period of 5 months. After this phase is completed, they will enter an open label phase for 3 months where they may utilize the device as much or as little as desired.
Device: RestoreX
PTT - randomized and open label Penile traction therapy in the straight position.




Primary Outcome Measures :
  1. Stretched Penile Length in Subjects Having Undergone Prostatectomy - Randomization Phase [ Time Frame: Baseline to 6 months post-prostatectomy ]
    Assess penile length pre and post completion of RestoreX traction therapy compared to control groups (no treatment) of subjects who have undergone robotic-assisted prostatectomy


Secondary Outcome Measures :
  1. Participant Compliance with Traction Device [ Time Frame: Baseline to 9 months post-prostatectomy ]
    Compare participant compliance with traction device

  2. Participant Satisfaction with Traction Device [ Time Frame: Baseline to 9 months post-prostatectomy ]
    Compare participant reported satisfaction with use of RestoreX traction device

  3. Evaluate Adverse Events with RestoreX Use [ Time Frame: Baseline to 9 months post-prostatectomy ]
    Evaluate any adverse events with use of RestoreX for penile lengthening

  4. Peyronie's Disease Development [ Time Frame: Baseline to 6 months post-prostatectomy ]
    Compare the rate of Peyronie's disease development among groups

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

  6. Participant Erectile Function [ Time Frame: Baseline to 6 months post-prostatectomy ]
    Evaluate and compare participant erectile function among groups

  7. Penile Length Outcome: Open-Label Phase [ Time Frame: 6 months to 9 months post-prostatectomy ]
    Compare penile length outcomes pre- and post-open label phase traction therapy

  8. RestoreX Utilization: Open-Label Phase [ Time Frame: 6 months to 9 months post-prostatectomy ]
    Evaluate the duration of treatment utilized during the open label phase of treatment

  9. Compare Pre-Surgical Factors and Outcomes [ Time Frame: Baseline to 6 months post-prostatectomy ]
    Review associations between pre-surgical factors (demographics, disease-specific factors, and standardized questionnaires) and outcomes



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 (Complications include contrast extravasation, anastomotic dehiscence of vesicourethral anastomosis, need for re-doing of vasicourethral anastomosis intra-operatively)


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


Contacts
Contact: Leanne Sandieson 507-293-2471 sandieson.leanne@mayo.edu

Locations
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Leanne Sandieson    507-293-2471    sandieson.leanne@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Landon W Trost Mayo Clinic
  Study Documents (Full-Text)

Documents provided by Landon W. Trost, Mayo Clinic:

Responsible Party: Landon W. Trost, Consultant, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03500419     History of Changes
Other Study ID Numbers: 18-001013
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Penile Diseases
Genital Diseases, Male