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Low-Intensity Extracorporeal Shockwave Therapy on Penile Rehabilitation After Robot-assisted Surgical Treatment of Genitourinary Cancers

ConditionsProstate CarcinomaErectile FunctionGenito Urinary Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age18-75
SponsorRegina Elena Cancer Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged ≤75 yrs;

PSA <10 ng/mL

Prostate Cancer ISUP grade ≤2 and cT≤2 at prostate biopsy

undergoing nerve sparing RARP;

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Low-intensity Extracorporeal Shock Wave Therapy (LiESWT)

    Device

    LiESWT will be performed with PiezoWave2 from Richard Wolf and ELvation® Medical. In a single session 12,000 shocks with an energy flux density of 0.16 mJ/mm2 will be applied (4,000 over the crura of the penis and 8,000 to the penil shaft). The penis is placed in a dedicated penile holder, stretched, and shockwaves are administered with a linear therapy source (applicator) using the linear shockwave tissue coverage (LSTC-ED®) technique which makes it possible to administer shockwaves homogenously to all of the erectile tissue.

  • PDE5 inhibitor (tadalafil)

    Drug

    Phosphodiesterase-5 (PDE5) inhibitors

Treatment groups

158 Participants
are divided into 2 treatment groups
Group A: PDE5i + LiESWTExperimental treatment 2 interventions
Group B: PDE5i aloneActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Erectile Function

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

Time frame
From enrollment to 1 year after treatment

Secondary outcomes

1

Urinary Continence

To evaluate the impact of LiESWT on continence status.

Time frame
From enrollment to 1 year after treatment
2

Adverse effects

To report any adverse effects and classify them according to the Clavien Dindo classification

Time frame
From enrollment to 1 year after treatment
3

Health Related Quality of Life

To compare health-related quality of life (HRQoL) outcomes at 3-, 6- and 12-months (mo) follow-up post-surgery

Time frame
From enrollment to 1 year after treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Regina Elena Cancer Institute

Lead sponsor

Source ClinicalTrials.gov
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