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Penile Length Maintenance Post-Prostatectomy
NA trial testing RestoreX in Prostate Cancer in 82 participants. Completed in 28 December 2020.
| Lead sponsor | Mayo Clinic |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 82 |
| Start date | 23 March 2018 |
| Primary completion | 28 December 2020 |
| Estimated completion | 28 December 2020 |
| Sites | 1 location across United States |
Mayo Clinic
18 and older, male only, with Prostate Cancer or Penile Diseases. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Stretched penile length measured in centimeters from pubic symphysis to glanular corona
| Group | Value | 95% CI |
|---|---|---|
| Control | 0.3 | ± 1.5 |
| PTT 1-2x Daily x 5-7 Days/Week x 5 Months | 1.6 | ± 1.0 |
The percentage of subjects to use a phosphodiesterase-5 inhibitor for erectogenic therapy use
| Group | Value | 95% CI |
|---|---|---|
| Control | 94 | |
| PTT 1-2x Daily x 5-7 Days/Week x 5 Months | 86 |
The percentage of subjects to use intracavernosal injections
| Group | Value | 95% CI |
|---|---|---|
| Control | 50 | |
| PTT 1-2x Daily x 5-7 Days/Week x 5 Months | 19 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Control | -6.5 | -21.5 – -2 |
| PTT 1-2x Daily x 5-7 Days/Week x 5 Months | 0 | -7.5 – 4 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Control | -3.5 | -7.0 – 0 |
| PTT 1-2x Daily x 5-7 Days/Week x 5 Months | 1 | -2 – 7 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Control | -3 | -6 – -1 |
| PTT 1-2x Daily x 5-7 Days/Week x 5 Months | 0 | -2.8 – 0.8 |
Time frame: Adverse events were collected from baseline until end of intervention, approximately 6 months.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Control | PTT 1-2x Daily x 5-7 Days/… |
|---|---|---|---|
| Temporary mile penile discomfort | General disorders | — | — |
| Temporary penile erythema or discoloration | Skin and subcutaneous tissue disorders | — | — |
Data from ClinicalTrials.gov NCT03500419 adverse events section.
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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