Clinical trial NCT03500406: Penile Lengthening Pre-Penile Prosthesis Implantation
Official title: Penile Lengthening Pre-Penile Prosthesis Implantation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Erectile Dysfunction
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-04-18
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Length Assessment of Penile Prosthesis Implanted
timeFrame: From baseline to 3 months
Secondary outcomes:
measure: Participant Compliance
timeFrame: From baseline to 3 months
measure: Participant Satisfaction With Traction
timeFrame: From baseline to 3 months
measure: Adverse Events With Use of Traction
timeFrame: From baseline to 3 months
measure: Operative Complications
timeFrame: 3, 6, 12 months post-operative
measure: Stretched Penile Length
timeFrame: From baseline to 12 months
measure: Participant Satisfaction Penile Length
timeFrame: Baseline to 12 months post-operative
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Mayo Clinic
name: Landon W Trost
role: PRINCIPAL_INVESTIGATOR
References: