Penile Length Maintenance Post-Prostatectomy

• Sponsor: Mayo Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT03500419
• Collaborator: (none)
• Enrollment: 82
• Location: 1
• Arms: 2
• Actual Duration (Months): 33.2
• Patients Per Site Per Month: 2.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer; Penile Diseases	Device: RestoreX; Other: No treatment	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 82 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Penile Length Maintenance Post-Prostatectomy
• Actual Study Start Date: Mar 23, 2018
• Actual Primary Completion Date: Dec 28, 2020
• Actual Study Completion Date: Dec 28, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Control 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.	Other: No treatment; Control group. No treatment will be given for the 6 months post-prostatectomy
Experimental: Group AB - PTT 1-2x daily x 5-7 days/week x 5 months 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.	Device: RestoreX; PTT - Penile traction therapy in the straight position.

Outcome Measures

Primary Outcome Measures

1. Change in Penile Length [Baseline, 6 months]

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

Secondary Outcome Measures

1. Erectogenic Therapy Use [6 months]

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

2. Intracavernosal Injections [6 months]

   The percentage of subjects to use intracavernosal injections

3. Change in Erectile Function Domain of International Index of Erectile Function (IIEF) [baseline, 6 months]

   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.

4. Change in Intercourse Satisfaction Domain of International Index of Erectile Function (IIEF) [Baseline, 6 months]

   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.

5. Change in Overall Satisfaction Domain of International Index of Erectile Function (IIEF) [Baseline, 6 months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Undergoing robotic prostatectomy

• Seen in the post-prostatectomy rehab clinic

Exclusion Criteria:

• Urethral complications from prostatectomy at the time of baseline visit

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic

Investigators

• Principal Investigator: Matthew Ziegelmann, MD, Mayo Clinic

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 3, 2019

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: Matthew (Matt) J. Ziegelmann, Principal Investigator, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT03500419
• Other Study ID Numbers: 18-001013
• First Posted: Apr 18, 2018
• Last Update Posted: Oct 20, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Penile Diseases

Study Results

Participant Flow

Arm/Group Title	Control	PTT 1-2x Daily x 5-7 Days/Week x 5 Months
Arm/Group Description	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	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.
Period Title: Overall Study
STARTED	27	55
COMPLETED	25	30
NOT COMPLETED	2	25

Baseline Characteristics

Arm/Group Title	Control	PTT 1-2x Daily x 5-7 Days/Week x 5 Months	Total
Arm/Group Description	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	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.	Total of all reporting groups
Overall Participants	27	55	82
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58.2 (4.5)	58.7 (6.8)	58.6 (6.1)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	27 100%	55 100%	82 100%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	1 1.8%	1 1.2%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 3.7%	4 7.3%	5 6.1%
White	25 92.6%	48 87.3%	73 89%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	1 3.7%	2 3.6%	3 3.7%
Region of Enrollment (participants) [Number]
United States	27 100%	55 100%	82 100%

Outcome Measures

1. Primary Outcome

Title	Change in Penile Length
Description	Stretched penile length measured in centimeters from pubic symphysis to glanular corona
Time Frame	Baseline, 6 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Control	PTT 1-2x Daily x 5-7 Days/Week x 5 Months
Arm/Group Description	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	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.
Measure Participants	25	30
Mean (Standard Deviation) [centimeters]	0.3 (1.5)	1.6 (1.0)

2. Secondary Outcome

Title	Erectogenic Therapy Use
Description	The percentage of subjects to use a phosphodiesterase-5 inhibitor for erectogenic therapy use
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Control	PTT 1-2x Daily x 5-7 Days/Week x 5 Months
Arm/Group Description	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	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.
Measure Participants	25	30
Number [percentage of subjects]	94	86

3. Secondary Outcome

Title	Intracavernosal Injections
Description	The percentage of subjects to use intracavernosal injections
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Control	PTT 1-2x Daily x 5-7 Days/Week x 5 Months
Arm/Group Description	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	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.
Measure Participants	25	30
Number [percentage of subjects]	50	19

4. Secondary Outcome

Title	Change in Erectile Function Domain of International Index of Erectile Function (IIEF)
Description	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.
Time Frame	baseline, 6 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Control	PTT 1-2x Daily x 5-7 Days/Week x 5 Months
Arm/Group Description	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	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.
Measure Participants	25	30
Median (Inter-Quartile Range) [units on a scale]	-6.5	0

5. Secondary Outcome

Title	Change in Intercourse Satisfaction Domain of International Index of Erectile Function (IIEF)
Description	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.
Time Frame	Baseline, 6 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Control	PTT 1-2x Daily x 5-7 Days/Week x 5 Months
Arm/Group Description	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	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.
Measure Participants	25	30
Median (Inter-Quartile Range) [units on a scale]	-3.5	1

6. Secondary Outcome

Title	Change in Overall Satisfaction Domain of International Index of Erectile Function (IIEF)
Description	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.
Time Frame	Baseline, 6 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Control	PTT 1-2x Daily x 5-7 Days/Week x 5 Months
Arm/Group Description	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	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.
Measure Participants	25	30
Median (Inter-Quartile Range) [units on a scale]	-3	0

Adverse Events

Time Frame	Adverse events were collected from baseline until end of intervention, approximately 6 months.
Arm/Group Title	Control		PTT 1-2x Daily x 5-7 Days/Week x 5 Months
Arm/Group Description	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		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.
All Cause Mortality
	Control		PTT 1-2x Daily x 5-7 Days/Week x 5 Months
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/27 (0%)		0/55 (0%)
Serious Adverse Events
	Control		PTT 1-2x Daily x 5-7 Days/Week x 5 Months
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/27 (0%)		0/55 (0%)
Other (Not Including Serious) Adverse Events
	Control		PTT 1-2x Daily x 5-7 Days/Week x 5 Months
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/27 (0%)		17/55 (30.9%)
General disorders
Temporary mile penile discomfort	0/27 (0%)	0	11/55 (20%)	11
Skin and subcutaneous tissue disorders
Temporary penile erythema or discoloration	0/27 (0%)	0	6/55 (10.9%)	6

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.