Clinical trial NCT03862599: Low Intensity Shock-wave Therapy (Li-ESWT) in Penile Rehabilitation After Radical Prostatectomy
Official title: Low Intensity Extracorporeal Shock-wave Therapy (Li-ESWT) in Penile Rehabilitation After Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Erectile Dysfunction Following Radical Prostatectomy
Keywords: erectile dysfunction
shockwave
treatment
prostatectomy
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
First posted: 2019-03-05
Enrollment: 100
Sex: MALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised controlled trial
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Erectile dysfunction (ED) is reported in up to 85% of men who have undergone a radical prostatectomy for prostate cancer. At present, this debilitating consequence of surgery is managed in a step-wise approach including oral medication, injections and in severe cases, insertion of a penile prosthesis. A few small studies have 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. Low-intensity shockwave therapy would be a non-invasive treatment to preserve and improve patient's sexual function.

Eligibility criteria: 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

Primary outcomes:
measure: Sexual Function
timeFrame: 6 months
Secondary outcomes:
measure: Penile length
timeFrame: 12 months
measure: Urinary Incontinence
timeFrame: 12 months
measure: Adverse Events
timeFrame: 12 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Trust
Study officials:
affiliation: Guy's and St Thomas' NHS Foundation Trust
name: Tet Yap, FRCS (Urol)
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.