Trial Outcomes & Findings for Penile Lengthening Pre-Penile Prosthesis Implantation (NCT NCT03500406)

NCT ID: NCT03500406

Last Updated: 2020-01-06

Results Overview

The primary objective is to assess the length of the penile prosthesis inserted into subjects following completion of RestoreX® traction therapy compared to the control group (no treatment)

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

24 participants

Primary outcome timeframe

From baseline to 3 months

Results posted on

2020-01-06

Participant Flow

Participant milestones

Participant milestones
Measure	Group 1 - Control No treatment will be administered and men will not have to delay their IPP procedure Control: No treatment	Group 2 - PTT 3x Daily x 3 Months Men will utilize penile traction therapy for 30 minutes three times daily for the 3 months prior to placement of their IPP RestoreX: Penile traction therapy in the straight position
Overall Study STARTED	4	20
Overall Study COMPLETED	4	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 - Control n=4 Participants No treatment will be administered and men will not have to delay their IPP procedure Control: No treatment	Group 2 - PTT 3x Daily x 3 Months n=20 Participants Men will utilize penile traction therapy for 30 minutes three times daily for the 3 months prior to placement of their IPP RestoreX: Penile traction therapy in the straight position	Total n=24 Participants Total of all reporting groups
Age, Continuous	64.5 years STANDARD_DEVIATION 8.9 • n=4 Participants	63.1 years STANDARD_DEVIATION 9.1 • n=20 Participants	63.8 years STANDARD_DEVIATION 9 • n=24 Participants
Sex: Female, Male Female	0 Participants n=4 Participants	0 Participants n=20 Participants	0 Participants n=24 Participants
Sex: Female, Male Male	4 Participants n=4 Participants	20 Participants n=20 Participants	24 Participants n=24 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	4 participants n=4 Participants	20 participants n=20 Participants	24 participants n=24 Participants

PRIMARY outcome

Timeframe: From baseline to 3 months

Population: Study was terminated due to PI change of subspecialties and no longer able to access the main study population. Sincere efforts were made but we were unable to collect data.

The primary objective is to assess the length of the penile prosthesis inserted into subjects following completion of RestoreX® traction therapy compared to the control group (no treatment)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From baseline to 3 months

Population: Study was terminated due to PI change of subspecialties and no longer able to access the main study population. Sincere efforts were made but we were unable to collect data.

Compare Participant compliance with traction device

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From baseline to 3 months

Population: Study was terminated due to PI change of subspecialties and no longer able to access the main study population. Sincere efforts were made but we were unable to collect data.

Compare patient reported satisfaction with use of traction device

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From baseline to 3 months

Population: Study was terminated due to PI change of subspecialties and no longer able to access the main study population. Sincere efforts were made but we were unable to collect data.

Evaluate any adverse events with use of RestoreX® for penile lengthening.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3, 6, 12 months post-operative

Population: Study was terminated due to PI change of subspecialties and no longer able to access the main study population. Sincere efforts were made but we were unable to collect data.

Compare intra- and/or post-operative complication rates.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From baseline to 12 months

Population: Study was terminated due to PI change of subspecialties and no longer able to access the main study population. Sincere efforts were made but we were unable to collect data.

Compare pre- and post-operative stretched penile lengths

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to 12 months post-operative

Population: Study was terminated due to PI change of subspecialties and no longer able to access the main study population. Sincere efforts were made but we were unable to collect data.

Compare participant satisfaction scores including satisfaction with overall penile length

Outcome measures

Outcome data not reported

Adverse Events

Group 1 - Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group 2 - PTT 3x Daily x 3 Months

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Landon Trost

Mayo Clinic

Phone: 507-284-3728

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place