Low-Intensity Extracorporeal Shockwave Therapy on Penile Rehabilitation After Robot-assisted Surgical Treatment of Genitourinary Cancers
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Enrollment
- 158
- Locations
- 2
- Primary Endpoint
- Erectile Function
Study Overview
Brief Summary
This prospective randomized controlled trial (RCT) is designed to provide high level evidence on the efficacy of Low-intensity Extracorporeal Shock Wave Therapy (Li-ESWT) in the treatment of post-Robot-Assisted (RA) Radical Prostatectomy (RP) erectile dysfunction (ED) in addition to PDE5 inhibitors (PDE5i) versus PDE5i alone. Our hypothesis is that early andrological rehabilitation that combines Li-ESWT and PDE5i could lead to faster and better recovery of valid erections for intercourse, with a greater rate of postoperative International Index of Erectile Function-5 (IIEF-5) compared to patients receiving PDE5i alone.
Detailed Description
Background / State of Art ED is a common complication after radical prostatectomy, with a prevalence ranging from 40% to 80% of patients 1,2.
This considerable variability depends on the degree (intrafascial vs interfascial) and laterality (unilateral vs bilateral) of nerve sparing performed, as well as the surgical approach.
There is still paucity of high-level evidences in terms of impact of surgical approach on postoperative outcomes after RP. Considering the same surgical approach, technique, surgeon experience, patient age and preoperative erectile function remain the main predictors of postoperative sexual function.
In this context rehabilitation is still debatable and there is a lack of clear recommendations regarding the use of PDE5i and other forms of therapy. However, a multi-centre double blind RCT (n = 423) in men aged < 68 years, with normal pre-treatment erectile function undergoing either open, conventional or robot-assisted laparoscopic nerve-sparing RP, tadalafil (5 mg) once per day improved participants EPIC (Expanded Prostate Cancer Index Composite) sexual domain-scores (least squares mean difference +9.6, 95% CI: 3.1-16.0) when compared to 20 mg 'on demand' or placebo at 9 months of follow-up 3. As a result, there has been a trend toward early use of PDE5i after RP as demonstrated in some studies 4.
Hypothesis and specific aims Hypothesis and Significance The use of nerve-sparing techniques during robotic surgery has been shown to improve recovery of erectile function. However, some patients still experience ED after undergoing bilateral nerve-sparing RARP. Possible causes can be the mechanical stretching or thermal damage to cavernous nerves, ischemic injuries or local inflammation caused by surgery itself 5. Moreover, after surgery this condition could be exacerbated by an increased fibrosis and decreased elasticity of the erectile tissue in the corpora cavernosa.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients aged ≤75 yrs;
- •PSA <10 ng/mL
- •Prostate Cancer ISUP grade ≤2 and cT≤2 at prostate biopsy
- •undergoing nerve sparing RARP;
- •preoperative IIEF-5 score ≥ 17;
- •First PSA (45d after surgery) <0.1
- •Prostate Cancer ISUP grade ≤2 pT<3b and at final pathology
- •≥ 18 yrs old;
- •compliants patients able to follow the study protocol and fill in IIEF-5 scores and EORTC quality of life questionnaires;
- •patients able to provide a written informed consent for the trial.
Exclusion Criteria
- •anaesthesiologic contraindications to robotic surgery
- •patients submitted to pelvic radiotherapy or androgen deprivation
- •patients reporting major postoperative complications (CD≥3)
- •cardiovascular contraindications to PDE5i medical treatment
Arms & Interventions
PDE5i + LiESWT
Patients receiving LiESWT plus early introduction of PDE5i
Intervention: Low-intensity Extracorporeal Shock Wave Therapy (LiESWT) (Device)
PDE5i + LiESWT
Patients receiving LiESWT plus early introduction of PDE5i
Intervention: PDE5 inhibitor (tadalafil) (Drug)
PDE5i alone
Control group, patients receiving PDE5i alone
Intervention: PDE5 inhibitor (tadalafil) (Drug)
Outcomes
Primary Outcomes
Erectile Function
Time Frame: From enrollment to 1 year after treatment
To investigate the impact of LiESWT in combination with early PDE5i administration versus early PDE5i alone on the penile rehabilitation of erectile dysfunction (ED) after RARP
Secondary Outcomes
- Urinary Continence(From enrollment to 1 year after treatment)
- Adverse effects(From enrollment to 1 year after treatment)
- Health Related Quality of Life(From enrollment to 1 year after treatment)
Investigators
Giuseppe SImone
MD
Regina Elena Cancer Institute