Erectile Dysfunction Following Radical Prostatectomy Clinical Trial
Official title:
Efficacy of RestoreX Penile Traction Therapy In Preserving Erectile Function Post-Prostatectomy
Evaluate the efficacy of the RestoreX penile traction device in preserving erectile function in men undergoing robotic-assisted prostatectomy. This study will evaluate men undergoing prostatectomy with bilateral nerve preservation and preserved baseline erectile function (moderate ED or better). The primary outcome will be changes in the IIEF-EFD scores between groups at 6 months. Secondary outcomes include differences in questionnaire outcomes at 3, 6, and 9 months.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | September 14, 2025 |
Est. primary completion date | September 14, 2024 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Undergoing bilateral nerve-sparing prostatectomy - >18 years old - Have a regular sexual partner for at least 6 months prior to study enrollment Exclusion Criteria: - Requiring adjuvant radiation therapy or androgen deprivation / androgen blockade post-operatively (by the time of enrollment) - Baseline severe erectile dysfunction as measured by the IIEF-EFD - Urethral complications from prostatectomy at the time of baseline visit including contrast extravasation, anastomotic dehiscence of vesicourethral anastomosis, need for re-doing of vesicourethral anastomosis intra-operatively |
Country | Name | City | State |
---|---|---|---|
United States | The Male Fertility and Peyronie's Clinic | Orem | Utah |
Lead Sponsor | Collaborator |
---|---|
Charitable Union for the Research and Education of Peyronie's Disease |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Erectile Function Post-Prostatectomy | Compare erectile function between treatment and control cohorts, as assessed by the International Index of Erectile Function, Erectile Function Domain (IIEF-EFD) at 6-months post-prostatectomy. IIEF-EFD scores 1-30, with higher scores representing better function. | 6 months | |
Secondary | Non-erectile function domains of the International Index of Erectile Function | Compare the non-erectile function domains of the International Index of Erectile Function between cohorts. This represents 4 additional scales, with min/max being 0-10, 0-10, 0-15, and 0-10; higher scores indicated better function. | 6 months | |
Secondary | International Index of Erectile Function from baseline to 6 months | Compare International Index of Erectile Function subdomains within cohorts from baseline to 6 months. Scale 1-30, with higher scores representing better outcomes. | 6 months | |
Secondary | Adverse events at 3 months | Evaluate number of participants reporting adverse events at 3 months. | 3 months | |
Secondary | Adverse events at 6 months | Evaluate number of participants reporting adverse events at 6 months | 6 months | |
Secondary | Adverse events at 9 months | Evaluate number of participants reporting adverse events at 9 months | 9 months | |
Secondary | International Index of Erectile Function from baseline to 9 months | Compare International Index of Erectile Function domains at 9 months compared to baseline. Scale is 1-30 with higher scores indicating better function. | 9 months | |
Secondary | International Index of Erectile Function between groups at 9 months | Compare International Index of Erectile Function domains at 9 months between cohorts (treatment arm, control). Scale is 1-30 with higher scores indicating better function. | 9 months | |
Secondary | Subjective questionnaire at 6 months | Compare subjective questionnaire results between cohorts at 6 months | 6 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
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