Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Penile Diseases

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Male Urogenital Diseases

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.

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.

PTT - Penile traction therapy in the straight position.

RestoreX

Control group. No treatment will be given for the 6 months post-prostatectomy

No treatment

Matthew Ziegelmann, MD

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.

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.

Penile Length Maintenance Post-Prostatectomy

Stretched penile length measured in centimeters from pubic symphysis to glanular corona

The percentage of subjects to use a phosphodiesterase-5 inhibitor for erectogenic therapy use

The percentage of subjects to use intracavernosal injections

Erectile function domain will be measured by using the International Index of Erectile Function (IIEF) questionnaire. IIEF is a validated, 15-item questionnaire that assesses 5 domains of sexual function: erectile function (range 1-30), orgasmic function (range 0-10), sexual desire (range 2-10), intercourse satisfaction (range 0-15), and overall sexual satisfaction (range 2-10). Each question was answered on a 6-point or 5-point scale from 0/1 to 5 (best) with a total possible score (sum of 5 domains) range of 5 to 75 with higher scores representing better function.

Intercourse satisfaction will be measured by using the International Index of Erectile Function (IIEF) questionnaire. IIEF is a validated, 15-item questionnaire that assesses 5 domains of sexual function: erectile function (range 1-30), orgasmic function (range 0-10), sexual desire (range 2-10), intercourse satisfaction (range 0-15), and overall sexual satisfaction (range 2-10). Each question was answered on a 6-point or 5-point scale from 0/1 to 5 (best) with a total possible score (sum of 5 domains) range of 5 to 75 with higher scores representing better function.

Overall satisfaction domain will be measured by using the International Index of Erectile Function (IIEF) questionnaire. IIEF is a validated, 15-item questionnaire that assesses 5 domains of sexual function: erectile function (range 1-30), orgasmic function (range 0-10), sexual desire (range 2-10), intercourse satisfaction (range 0-15), and overall sexual satisfaction (range 2-10). Each question was answered on a 6-point or 5-point scale from 0/1 to 5 (best) with a total possible score (sum of 5 domains) range of 5 to 75 with higher scores representing better function.

Mayo Clinic

Principal Investigator

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

No treatment: Control group. No treatment was given for the 6 months post-prostatectomy

Control

Men utilized penile traction therapy for 30 minutes 1-2 times daily, 5-7 times a week, beginning 4 weeks post-prostatectomy for a period of 5 months.

RestoreX: PTT - Penile traction therapy in the straight position.

PTT 1-2x Daily x 5-7 Days/Week x 5 Months

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Matthew (Matt) J. Ziegelmann, M.D.

6 months data was not collected nor analyzed for 2 subjects in control arm and 25 subjects in PTT arm.

Change in Penile Length

Erectogenic Therapy Use

Intracavernosal Injections

6 months data was not collected nor analyzed for 2 subjects in control arm and 25 subjects in PTT arm. Negative denotes loss of function.

Spots Global Cancer Trial Database for penile diseases