Penile Lengthening Pre-Penile Prosthesis Implantation

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-23

Study Completion Date

2019-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Establish Implant Accuracy With X-PSI Knee System

NCT03275246

Knee Osteoarthritis Post-traumatic Osteoarthritis

TERMINATED NA

SYNOSTE Nitinail System Trial

NCT03752814

Leg Length Inequality

TERMINATED NA

MRI Scanning of People With MR Safe Orthopedic Implants That Are Made of Metal

NCT01570543

Implants

WITHDRAWN

Study to Assess the Pain, Satisfaction, and Quality of Life of Patients With FITBONE® Lengthening Nail

NCT06156384

Leg Length Inequality

RECRUITING

Evaluation of the CR Plug (Allograft) for the Treatment of a Cartilage Injury in the Knee.

NCT00793104

Knee Injury

TERMINATED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Erectile Dysfunction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1 - Control

No treatment will be administered and men will not have to delay their IPP procedure

Group Type SHAM_COMPARATOR

Control

Intervention Type OTHER

No treatment

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

Group Type EXPERIMENTAL

RestoreX

Intervention Type DEVICE

Penile traction therapy in the straight position

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

RestoreX

Penile traction therapy in the straight position

Intervention Type DEVICE

Control

No treatment

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No