Erectile Dysfunction Following Radical Prostatectomy Clinical Trial
— LiST-PRPOfficial title:
Low Intensity Extracorporeal Shock-wave Therapy (Li-ESWT) in Penile Rehabilitation After Radical Prostatectomy
NCT number | NCT03862599 |
Other study ID # | 250004 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 1, 2021 |
Est. completion date | May 1, 2025 |
Erectile dysfunction (ED) is reported in up to 85% of men who have undergone a radical prostatectomy for prostate cancer. A few small studies have recently shown that low-intensity shockwave therapy may improve sexual performance in men with ED. However, the optimal dosage and length of treatment is yet to be determined. The investigators propose a randomised trial evaluating the efficacy and safety of low-intensity shockwave therapy in men with ED following prostatectomy surgery.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | May 1, 2025 |
Est. primary completion date | October 1, 2024 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 40 Years to 65 Years |
Eligibility | Inclusion Criteria: - Age 40 - 65 - Diagnosed with low/intermediate-risk prostate cancer: - PSA < 20 ng/ml - Gleason score < 8 - PCa stage =< T2b - Baseline IIEF-ED 17-30 without erectogenic aids - No pre-operative urinary incontinence (no usage of urinary pads) - Sexually active - Able to understand and complete patient questionnaires - Consent to participate Exclusion Criteria: - Anatomical abnormalities in the genitalia or pelvic region - Post-RP complications that could impact safety or effectiveness of ESWT (eg. hematoma, fistula, unresolved anastomotic leak) - Incomplete tumor removal (positive surgical margin) - Tumor upstaging beyond T2b - Nerve sparing score > 5 - Previous or scheduled treatment with pelvic radiotherapy and/or androgen deprivation therapy - Untreated hypogonadism (serum total testosterone < 300 mg/dL) - Anti-coagulant medication, except acetylsalicyclic acid up to 100mg daily - Any other condition that would prevent the patient from completing the study, as judged by the principle investigator |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Guy's and St Thomas' NHS Trust | London |
Lead Sponsor | Collaborator |
---|---|
Guy's and St Thomas' NHS Foundation Trust |
United Kingdom,
Kalyvianakis D, Memmos E, Mykoniatis I, Kapoteli P, Memmos D, Hatzichristou D. Low-Intensity Shockwave Therapy for Erectile Dysfunction: A Randomized Clinical Trial Comparing 2 Treatment Protocols and the Impact of Repeating Treatment. J Sex Med. 2018 Mar;15(3):334-345. doi: 10.1016/j.jsxm.2018.01.003. Epub 2018 Feb 1. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sexual Function | Measurement of average change in IIEF-ED from baseline (pre-RP) to 24 week-FU 22-25: No erectile dysfunction 17-21: Mild erectile dysfunction 12-16: Mild to moderate erectile dysfunction 8-11: Moderate erectile dysfunction 5-7: Severe erectile dysfunction 5 being the worst outcome | 6 months | |
Secondary | Penile length | Clinical measurement of change in stretched flaccid penile length from baseline and time points to 12 months | 12 months | |
Secondary | Urinary Incontinence | Measurement of average change in EPIC questionnaire from baseline (pre-RP) to 24 week-FU and time points to 12 months | 12 months | |
Secondary | Adverse Events | Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 | 12 months |
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