Early Shockwave Therapy for Post-RP ED

Dornier MedTech

Status: Unknown

Conditions: Erectile Dysfunction Following Radical Prostatectomy

Treatments: Device: Dornier Aries 2 (with sham applicator); Device: Dornier Aries 2 (with active applicator)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03905057

EspPRP-ED_001

Details and patient eligibility

About

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).

Full 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.

Enrollment: 94 estimated patients

Sex: Male

Ages: 50 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men scheduled for robotic bilateral nerve-sparing radical prostatectomy

• Diagnosed with low/intermediate-risk prostate cancer:

  • PSA < 20 ng/ml
  • Gleason score < 8
  • PCa stage =< T2b

• Baseline IIEF-ED 22-30 without erectogenic aids

• No urinary incontinence (no usage of urinary pads)

• Sexually active, in a stable heterosexual relationship

• 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 < 4
• Previous or scheduled treatment with pelvic radiotherapy and/or androgen deprivation therapy
• Untreated hypogonadism (serum total testosterone < 300 mg/dL)
• Anti-coagulant medication, or any blood coagulation disorders (INR > 3)
• Any other condition that would prevent the patient from completing the study, as judged by the principle investigator

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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94 participants in 2 patient groups

Sham ESWT + 5mg Tadalafil

Sham Comparator group

Description:

Patients will receive shockwave treatments (12 sessions for all subjects, 5000 shockwaves at each session), using a sham applicator which is highly similar to the active applicator except that the sham applicator does not emit shockwaves, twice a week (total of 6 weeks) without treatment interval. Patients will receive Tadalafil 5mg for 24 weeks daily beginning the day of removal of the urinary catheter.

Treatment:

Device: Dornier Aries 2 (with sham applicator)

Active ESWT + 5mg Tadalafil

Active Comparator group

Description:

Patients will receive shockwave treatments (12 sessions for all subjects, 5000 shockwaves at each session), twice a week (total of 6 weeks). Patients will receive Tadalafil 5mg for 24 weeks daily beginning the day of removal of the urinary catheter.

Treatment:

Device: Dornier Aries 2 (with active applicator)