Early Shockwave Therapy for Post-RP ED

NCT03905057 | Unknown

• 1 other identifier: EspPRP-ED_001
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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).

Conditions

Erectile Dysfunction Following Radical Prostatectomy

Outcome Measures

Primary Outcomes (2)

• 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

  EF domain of the IIEF questionnaire will be completed. IIEF-EF consists of items 1,2,3,4,5,15 of the IIEF questionnaire.According to the score of the iIEF-EF there are five categories of erectile function: 1-10 (Severe Erectile Dysfunction), 11-16(Moderate dysfunction), 17-21(Mild to moderate dysfunction), 22-25(Mild dysfunction), 26-30 (No dysfunction)

  28-week follow up visit

• 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

  EF domain of the IIEF questionnaire will be completed. IIEF-EF consists of items 1,2,3,4,5,15 of the IIEF questionnaire.According to the score of the iIEF-EF there are five categories of erectile function: 1-10 (Severe Erectile Dysfunction), 11-16(Moderate dysfunction), 17-21(Mild to moderate dysfunction), 22-25(Mild dysfunction), 26-30 (No dysfunction)

  24-month follow up visit

Secondary Outcomes (9)

• Proportion of patients achieving Erectile Function (EF) domain score of the International Index of Erectile Function (IIEF) of 22-30 in each group

  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

• Change in each domain of the full International Index of Erectile Function (IIEF) score

  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

• Change in Erection Hardness Score

  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

• Change in Global Assessment Questionnaire (GAQ) score

  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

• Change in stretched flaccid penile length

  baseline, 12-weeks post-RP, 24-weeks post-RP, 52-weeks post-RP, 18-months post-RP and 24-months post-RP

Study Arms (2)

Sham ESWT + 5mg Tadalafil

SHAM COMPARATOR

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.

Device: Dornier Aries 2 (with sham applicator)

Active ESWT + 5mg Tadalafil

ACTIVE COMPARATOR

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.

Device: Dornier Aries 2 (with active applicator)

Interventions

Dornier Aries 2 (with active applicator) DEVICE

Active ESWT: 5000 shockwaves per session. 2 ESWT sessions per week, 12 sessions in total.

Active ESWT + 5mg Tadalafil

Dornier Aries 2 (with sham applicator) DEVICE

Sham ESWT - No shockwave administered

Sham ESWT + 5mg Tadalafil

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dornier MedTech Systems: lead
• Hospital Universitari de Bellvitge: collaborator

Study Sites (1)

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

RECRUITING

Central Study Contacts

Josep Torremadé, MD, PhD

CONTACT

+34 932607500; jtorremade@bellvitgehospital.cat

Begoña Etcheverry, MD

CONTACT

932607500; betcheverry@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: April 5, 2019
• Study Start: March 26, 2018
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: April 8, 2019

Record last verified: 2019-04

Locations

ES (1)