Penile Length Maintenance Post-Prostatectomy

Mayo Clinic

Status: Completed

Conditions: Penile Diseases; Prostate Cancer

Treatments: Device: RestoreX; Other: No treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT03500419

18-001013

Details and patient eligibility

About

The objective of the current study is to evaluate the efficacy of a novel, class I (ie. lowest risk, clinical studies not required) medical penile traction device in preventing loss of penile length in men undergoing robotic-assisted prostatectomy.

Full description

The treatment of prostate cancer results in several known sexual dysfunctions, including erectile dysfunction, orgasmic dysfunction, ejaculatory dysfunction, penile curvature (Peyronie's disease), and reduced penile length. Among the dysfunctions, loss of penile length is often one that results in significant distress and bother to patients. Beyond the esthetic concerns, reduced penile length may lead to inability to participate in sexual intercourse, difficulty with future interventions to restore erectile function, and lead to worsened urinary hygiene.

Penile traction therapy (PTT) is currently the best available treatment to maintain or restore lost penile length due to conditions that reduce length. To date, no studies have evaluated the benefits of using PTT in this clinical setting. The objective of the current study is to evaluate the efficacy of a novel penile traction device (RestoreX®), created and funded through Mayo Ventures, in maintaining or restoring reduced penile length.

To accomplish the study, a population of men from Mayo Clinic who have undergone a prostatectomy will be enrolled and randomized to utilize the device for varying amounts of time. Outcomes will be assessed at 6 and 9 months post-prostatectomy and results are to be used with the intent to publish in a scientific journal.

Enrollment: 82 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Undergoing robotic prostatectomy
• Seen in the post-prostatectomy rehab clinic

Exclusion criteria

• Urethral complications from prostatectomy at the time of baseline visit

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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82 participants in 2 patient groups

Control

Active Comparator group

Description:

No treatment will be administered for the initial 6 months post-prostatectomy. This is necessary as a measure to review post-prostatectomy penile length changes.

Treatment:

Other: No treatment

Group AB - PTT 1-2x daily x 5-7 days/week x 5 months

Experimental group

Description:

Men will utilize penile traction therapy for 30 minutes 1-2 times daily, 5-7 times a week, beginning 4 weeks post-prostatectomy. Men will remain in this phase for a period of 5 months.

Treatment:

Device: RestoreX