Penile Length Maintenance Post-Prostatectomy

Prostate Cancer Clinical Trial

Official title:

Penile Length Maintenance Post-Prostatectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03500419
• Other study ID #: 18-001013
• Status: Completed
• Phase: N/A
• Start date: March 23, 2018
• Est. completion date: December 28, 2020

Study information

• Verified date: September 2021
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: December 28, 2020
• Est. primary completion date: December 28, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Undergoing robotic prostatectomy

• Seen in the post-prostatectomy rehab clinic

Exclusion Criteria:

• Urethral complications from prostatectomy at the time of baseline visit

Related Conditions & MeSH terms

• Penile Diseases
• Prostate Cancer

Intervention

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

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

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Penile Length	Stretched penile length measured in centimeters from pubic symphysis to glanular corona	Baseline, 6 months
Secondary	Erectogenic Therapy Use	The percentage of subjects to use a phosphodiesterase-5 inhibitor for erectogenic therapy use	6 months
Secondary	Intracavernosal Injections	The percentage of subjects to use intracavernosal injections	6 months
Secondary	Change in Erectile Function Domain of International Index of Erectile Function (IIEF)	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.	baseline, 6 months
Secondary	Change in Intercourse Satisfaction Domain of International Index of Erectile Function (IIEF)	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.	Baseline, 6 months
Secondary	Change in Overall Satisfaction Domain of International Index of Erectile Function (IIEF)	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.	Baseline, 6 months

External Links

•   Mayo Clinic Clinical Trials