Penile Lengthening Pre-Penile Prosthesis Implantation

Erectile Dysfunction Clinical Trial

Official title:

Penile Lengthening Pre-Penile Prosthesis Implantation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03500406
• Other study ID #: 17-011052
• Status: Terminated
• Phase: N/A
• Start date: March 23, 2018
• Est. completion date: April 1, 2019

Study information

• Verified date: January 2020
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: April 1, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Device:
• RestoreX
Penile traction therapy in the straight position

Other:
• Control
No treatment

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length Assessment of Penile Prosthesis Implanted	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)	From baseline to 3 months
Secondary	Participant Compliance	Compare Participant compliance with traction device	From baseline to 3 months
Secondary	Participant Satisfaction With Traction	Compare patient reported satisfaction with use of traction device	From baseline to 3 months
Secondary	Adverse Events With Use of Traction	Evaluate any adverse events with use of RestoreX® for penile lengthening.	From baseline to 3 months
Secondary	Operative Complications	Compare intra- and/or post-operative complication rates.	3, 6, 12 months post-operative
Secondary	Stretched Penile Length	Compare pre- and post-operative stretched penile lengths	From baseline to 12 months
Secondary	Participant Satisfaction Penile Length	Compare participant satisfaction scores including satisfaction with overall penile length	Baseline to 12 months post-operative

External Links

•   Mayo Clinic Clinical Trials