NCT03756688

Brief Summary

The objective of the current study is to evaluate the efficacy of a novel penile traction device in restoring lost penile length in men with type 2 diabetes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Nov 2018

Typical duration for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 7, 2018

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

November 24, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 28, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2021

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

February 21, 2023

Completed
Last Updated

February 21, 2023

Status Verified

February 1, 2023

Enrollment Period

2.4 years

First QC Date

November 24, 2018

Results QC Date

December 21, 2022

Last Update Submit

February 17, 2023

Conditions

Diabetes Mellitus, Type 2Penile Diseases

Outcome Measures

Primary Outcomes (1)

  • Penile Length Change Between Baseline and Month 6

    Primary objective of this study is to assess penile length pre and post completion of RestoreX traction therapy compared to control groups (no treatment) of Diabetes Type II patients. Measurements were obtained at baseline and 6 months post-prostatectomy.

    Baseline to 6 months

Secondary Outcomes (6)

  • Patient Compliance With Traction Therapy

    6 months

  • Patient Reported Satisfaction With Traction Therapy at 6 Months.

    6 months

  • Number of Participants With Adverse Events With Use of RestoreX

    3 and 6 months post-prostatectomy

  • Number of Participants With De-novo Peyronie's Disease Development

    6 months

  • Subjective Comparison of Changes in Penile Length

    6 months

  • +1 more secondary outcomes

Study Arms (4)

Group 1: Control

NO INTERVENTION

No treatment will be administered for the entirety of the study (6 months)

Group 2: Treatment

EXPERIMENTAL

PTT for 30 min 2x/ day x 3 months, followed by no treatment x 3 months

Device: RestoreX PTT - 3 months

Group 3: Treatment

EXPERIMENTAL

PTT for 30 min 2x/day x 3 months, followed by once weekly (30 minutes) x 3 months

Device: RestoreX PTT - 6 months

Group 4: Treatment

EXPERIMENTAL

PTT for 30 min 2x day x 6 months

Device: RestoreX PTT - 6 months

Interventions

RestoreX PTT - 6 monthsDEVICE

Penile traction therapy in straight position for all 6 months.

Group 3: TreatmentGroup 4: Treatment
RestoreX PTT - 3 monthsDEVICE

Penile traction therapy in straight position for first phase (3 months)

Group 2: Treatment

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Men with Diabetes Mellitus, Type II

You may not qualify if:

  • Any evidence of end-organ failure attributed to DM (assessed based on medical history / patient history alone)
  • Loss of fingers / toes.
  • CKD Stage IV or greater.
  • Retinopathy
  • Myocardial infarction.
  • Cerebrovascular accident.
  • Indwelling penile prosthesis or prior history of penile prosthesis.
  • Peyronie's disease at baseline.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Penile Diseases

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Results Point of Contact

Title
Dr. Landon Trost
Organization
Mayo Clinic
landontrost@gmail.com
507-202-1995

Study Officials

  • Matthew Ziegelmann, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The provider and outcome assessor will be blinded to the patient's study arm for all length assessments. Additionally, the assessor will be blinded to prior length measurements.
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: Patients will be randomized into one of four groups: 1. Penile Traction Therapy (PTT) for 30 min 2x/day x 3 months, followed by no treatment x 3 months 2. PTT for 30 min 2x/day x 3 months, followed by once weekly (30 minutes) x 3 months 3. PTT for 30 min 2x/day x 6 months 4. Control (no treatment)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 24, 2018

First Posted

November 28, 2018

Study Start

November 7, 2018

Primary Completion

March 18, 2021

Study Completion

March 18, 2021

Last Updated

February 21, 2023

Results First Posted

February 21, 2023

Record last verified: 2023-02

Locations

US(1)