Penile Lengthening Pre-Penile Prosthesis Implantation

Mayo Clinic

Status: Terminated

Conditions: Erectile Dysfunction

Treatments: Device: RestoreX; Other: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT03500406

17-011052

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Group 1 - Control

Sham Comparator group

Description:

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

Treatment:

Other: Control

Group 2 - PTT 3x daily x 3 months

Experimental group

Description:

Men will utilize penile traction therapy for 30 minutes three times daily for the 3 months prior to placement of their IPP

Treatment:

Device: RestoreX