Clinical trial NCT03905057: Early Shockwave Therapy for Post-RP ED
Official title: Effect of Early Shockwave Therapy Protocol for Preservation and Restoration of Erectile Function After Nerve-sparing Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Erectile Dysfunction Following Radical Prostatectomy
Lead sponsor: Dornier MedTech Systems
Sponsor class: INDUSTRY
Collaborators: name: Hospital Universitari de Bellvitge
First posted: 2019-04-05
Enrollment: 94
Sex: MALE
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: The difference in average Erectile Function (EF) domain score of the International Index of Erectile Function (IIEF) between the groups at 28-week follow up
timeFrame: 28-week follow up visit
measure: The difference in average Erectile Function (EF) domain score of the International Index of Erectile Function (IIEF) between the groups at 24-month follow up
timeFrame: 24-month follow up visit
Secondary outcomes:
measure: Proportion of patients achieving Erectile Function (EF) domain score of the International Index of Erectile Function (IIEF) of 22-30 in each group
timeFrame: baseline, 12-weeks post-RP, 24-weeks post-RP, 28-weeks post-RP, 52-weeks post-RP, 18-months post-RP and 24-months post-RP
measure: Change in each domain of the full International Index of Erectile Function (IIEF) score
timeFrame: baseline, 12-weeks post-RP, 24-weeks post-RP, 28-weeks post-RP, 52-weeks post-RP, 18-months post-RP and 24-months post-RP
measure: Change in Erection Hardness Score
timeFrame: baseline, 12-weeks post-RP, 24-weeks post-RP, 28-weeks post-RP, in-office ICI visits, 52-weeks post-RP, 18-months post-RP and 24-months post-RP
measure: Change in Global Assessment Questionnaire (GAQ) score
timeFrame: 12-weeks post-RP, 24-weeks post-RP, 28-weeks post-RP, 52-weeks post-RP, 18-months post-RP and 24-months post-RP
measure: Change in stretched flaccid penile length
timeFrame: baseline, 12-weeks post-RP, 24-weeks post-RP, 52-weeks post-RP, 18-months post-RP and 24-months post-RP
measure: Change in degree of incontinence
timeFrame: First treatment session, 12-weeks post-RP, 24-weeks post-RP, 52-weeks post-RP, 18-months post-RP and 24-months post-RP
measure: Oncologic status
timeFrame: 12-weeks post-RP, 24-weeks post-RP, 52-weeks post-RP, 18-months post-RP and 24-months post-RP
measure: Time to recovery of penetration erection hardness without erectogenic aids
timeFrame: baseline, 12-weeks post-RP, 24-weeks post-RP, 28-weeks post-RP, in-office ICI visits, 52-weeks post-RP, 18-months post-RP and 24-months post-RP
measure: Tolerability to and reliance on intracavernosal injections for satisfactory erections: Visual Analog Scale for Pain
timeFrame: ICI visits, 52-weeks post-RP, 18-months post-RP and 24-months post-RP
Other outcomes:
Locations:
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona
Study officials:
References: