NCT03905057

Early Shockwave Therapy for Post-RP ED

Effect of Early Shockwave Therapy Protocol for Preservation and Restoration of Erectile Function After Nerve-sparing Radical Prostatectomy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 94 (estimated)
• Sponsor: Dornier MedTech Systems · Industry
• Sex: Male
• Age: 50 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This pilot study aims to explore the feasibility, safety and effectiveness of two different extracorporeal shock wave therapy (ESWT) protocols for patients receiving nerve-sparing radical prostatectomy (RP).

Detailed description

This is an open-label, randomized, 2-parallel-arm trial (n=94). All patients will receive (A) sham (n=47) or (B) active ESWT (n=47) twice/week for 6 weeks (12 sessions total). Concurrently, all patients will receive daily tadalafil 5mg for 24 weeks. Patients will then undergo a 4 week washout period without erectogenic aids, and return for a 28-week evaluation. Subsequently, patients requiring further erectogenic aids after 28 weeks will be offered intracavernosal injections (ICI) of prostaglandin E1 (PGE1). Random assignment will be performed by computer program (eg. randomizer.org), in a design that obtains equal sample size per group. All patients will be followed for a period of 24 months post-RP. Follow-up protocol includes evaluation of the IIEF, EHS, GAQ, ICI usage and tolerability, stretched flaccid penile length, urinary incontinence, and oncologic status.

Conditions

• Erectile Dysfunction Following Radical Prostatectomy

Interventions

Type	Name	Description
DEVICE	Dornier Aries 2 (with active applicator)	Active ESWT: 5000 shockwaves per session. 2 ESWT sessions per week, 12 sessions in total.
DEVICE	Dornier Aries 2 (with sham applicator)	Sham ESWT - No shockwave administered

Timeline

• Start date: 2018-03-26
• Primary completion: 2021-06-01
• Completion: 2021-06-01
• First posted: 2019-04-05
• Last updated: 2019-04-08

Locations

1 site across 1 country: Spain