Back to resultsEarly Shockwave Therapy for Post-RP ED
Primary Purpose
Erectile Dysfunction Following Radical Prostatectomy
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Dornier Aries 2 (with active applicator)
Dornier Aries 2 (with sham applicator)
Sponsored by
About this trial
This is an interventional treatment trial for Erectile Dysfunction Following Radical Prostatectomy
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
Sites / Locations
- Hospital Universitari de BellvitgeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Active Comparator
Arm Label
Sham ESWT + 5mg Tadalafil
Active ESWT + 5mg Tadalafil
Arm 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.
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.
Outcomes
Primary Outcome Measures
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)
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)
Secondary Outcome Measures
Proportion of patients achieving Erectile Function (EF) domain score of the International Index of Erectile Function (IIEF) of 22-30 in each group
The proportion of patients achieving Erectile Function (EF) domain score of the International Index of Erectile Function (IIEF) of 22-30 (indicating mild to no erectile dysfunction) in each group. 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).
Change in each domain of the full International Index of Erectile Function (IIEF) score
Change in each domain of the full International Index of Erectile Function (IIEF) score from baseline and from each 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)
Change in Erection Hardness Score
The Erection Hardness Score (EHS) is a single-item Likert scale to assess erectile dysfunction. Male patients have to answer the question "How would you rate the hardness of your erection?". They answer by selecting from the following options: 0 = Penis does not enlarge; 1 = Penis is large, but not hard; 2 = Penis is hard, but not hard enough for penetration; 3 = Penis is hard enough for penetration, but not completely hard; 4 = Penis is completely hard and fully rigid.
Change in Global Assessment Questionnaire (GAQ) score
The Global Assessment Questionnaire (GAQ) is a tool to evaluate the efficacy of the treatment. Patients will be asked and provide scores (on a scale of 1 to 5) for treatment related, with a score of 1 being least favourable and 5 being most favourable.
Change in stretched flaccid penile length
The flaccid penis of each patient will be stretched and measured from the base of the penis to the tip of the glans.
Change in degree of incontinence
Incontinence will be determined by the number of pads used per day and the time to achieve 0-1 pad will be compared between the groups.
Oncologic status
The oncologic status of each patient will be evaluated determined by the serum prostate specific antigen (PSA) levels.
Time to recovery of penetration erection hardness without erectogenic aids
Penetration erection hardness is having an EHS score of 3-4. The Erection Hardness Score (EHS) is a single-item Likert scale to assess erectile dysfunction. Male patients have to answer the question "How would you rate the hardness of your erection?". They answer by selecting from the following options: 0 = Penis does not enlarge; 1 = Penis is large, but not hard; 2 = Penis is hard, but not hard enough for penetration; 3 = Penis is hard enough for penetration, but not completely hard; 4 = Penis is completely hard and fully rigid.
Tolerability to and reliance on intracavernosal injections for satisfactory erections: Visual Analog Scale for Pain
Patients who are unsatisfied with their erectile function at the 28 week visit, will be offered intracavernosal injections (10mg PGE1, 2x/week) for the remaining duration of the study. During each in-office ICI, patients will report pain tolerability (Visual Analog Scale for Pain), and maximum EHS achieved. Patients will be allowed to stop ICI if they report satisfactory erections without any erectogenic aids for 2 weeks. Patients will be allowed to resume ICI if erectile function decreases, and they report unsatisfactory erections with erectogenic aids for 2 weeks. Dates of stopping and/or resuming ICI will be recorded. At the 52 weeks, 18 and 24 months post-RP follow-up sessions, All patients will self-administer ICI of 10mg PGE1 during the visit, and report pain tolerability (Visual Analog Scale for Pain), and maximum EHS achieved.
Full Information
NCT ID
NCT03905057
First Posted
March 26, 2019
Last Updated
April 4, 2019
Sponsor
Dornier MedTech Systems
Collaborators
Hospital Universitari de Bellvitge
1. Study Identification
Unique Protocol Identification Number
NCT03905057
Brief Title
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
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 26, 2018 (Actual)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
June 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dornier MedTech Systems
Collaborators
Hospital Universitari de Bellvitge
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction Following Radical Prostatectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
94 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sham ESWT + 5mg Tadalafil
Arm Type
Sham Comparator
Arm 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.
Arm Title
Active ESWT + 5mg Tadalafil
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Dornier Aries 2 (with active applicator)
Intervention Description
Active ESWT: 5000 shockwaves per session. 2 ESWT sessions per week, 12 sessions in total.
Intervention Type
Device
Intervention Name(s)
Dornier Aries 2 (with sham applicator)
Intervention Description
Sham ESWT - No shockwave administered
Primary Outcome Measure Information:
Title
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
Description
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)
Time Frame
28-week follow up visit
Title
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
Description
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)
Time Frame
24-month follow up visit
Secondary Outcome Measure Information:
Title
Proportion of patients achieving Erectile Function (EF) domain score of the International Index of Erectile Function (IIEF) of 22-30 in each group
Description
The proportion of patients achieving Erectile Function (EF) domain score of the International Index of Erectile Function (IIEF) of 22-30 (indicating mild to no erectile dysfunction) in each group. 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).
Time Frame
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
Title
Change in each domain of the full International Index of Erectile Function (IIEF) score
Description
Change in each domain of the full International Index of Erectile Function (IIEF) score from baseline and from each 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)
Time Frame
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
Title
Change in Erection Hardness Score
Description
The Erection Hardness Score (EHS) is a single-item Likert scale to assess erectile dysfunction. Male patients have to answer the question "How would you rate the hardness of your erection?". They answer by selecting from the following options: 0 = Penis does not enlarge; 1 = Penis is large, but not hard; 2 = Penis is hard, but not hard enough for penetration; 3 = Penis is hard enough for penetration, but not completely hard; 4 = Penis is completely hard and fully rigid.
Time Frame
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
Title
Change in Global Assessment Questionnaire (GAQ) score
Description
The Global Assessment Questionnaire (GAQ) is a tool to evaluate the efficacy of the treatment. Patients will be asked and provide scores (on a scale of 1 to 5) for treatment related, with a score of 1 being least favourable and 5 being most favourable.
Time Frame
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
Title
Change in stretched flaccid penile length
Description
The flaccid penis of each patient will be stretched and measured from the base of the penis to the tip of the glans.
Time Frame
baseline, 12-weeks post-RP, 24-weeks post-RP, 52-weeks post-RP, 18-months post-RP and 24-months post-RP
Title
Change in degree of incontinence
Description
Incontinence will be determined by the number of pads used per day and the time to achieve 0-1 pad will be compared between the groups.
Time Frame
First treatment session, 12-weeks post-RP, 24-weeks post-RP, 52-weeks post-RP, 18-months post-RP and 24-months post-RP
Title
Oncologic status
Description
The oncologic status of each patient will be evaluated determined by the serum prostate specific antigen (PSA) levels.
Time Frame
12-weeks post-RP, 24-weeks post-RP, 52-weeks post-RP, 18-months post-RP and 24-months post-RP
Title
Time to recovery of penetration erection hardness without erectogenic aids
Description
Penetration erection hardness is having an EHS score of 3-4. The Erection Hardness Score (EHS) is a single-item Likert scale to assess erectile dysfunction. Male patients have to answer the question "How would you rate the hardness of your erection?". They answer by selecting from the following options: 0 = Penis does not enlarge; 1 = Penis is large, but not hard; 2 = Penis is hard, but not hard enough for penetration; 3 = Penis is hard enough for penetration, but not completely hard; 4 = Penis is completely hard and fully rigid.
Time Frame
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
Title
Tolerability to and reliance on intracavernosal injections for satisfactory erections: Visual Analog Scale for Pain
Description
Patients who are unsatisfied with their erectile function at the 28 week visit, will be offered intracavernosal injections (10mg PGE1, 2x/week) for the remaining duration of the study. During each in-office ICI, patients will report pain tolerability (Visual Analog Scale for Pain), and maximum EHS achieved. Patients will be allowed to stop ICI if they report satisfactory erections without any erectogenic aids for 2 weeks. Patients will be allowed to resume ICI if erectile function decreases, and they report unsatisfactory erections with erectogenic aids for 2 weeks. Dates of stopping and/or resuming ICI will be recorded. At the 52 weeks, 18 and 24 months post-RP follow-up sessions, All patients will self-administer ICI of 10mg PGE1 during the visit, and report pain tolerability (Visual Analog Scale for Pain), and maximum EHS achieved.
Time Frame
ICI visits, 52-weeks post-RP, 18-months post-RP and 24-months post-RP
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Josep Torremadé, MD, PhD
Phone
+34 932607500
Ext
2747
Email
jtorremade@bellvitgehospital.cat
First Name & Middle Initial & Last Name or Official Title & Degree
Begoña Etcheverry, MD
Phone
932607500
Ext
2747
Email
betcheverry@hotmail.com
Facility Information:
Facility Name
Hospital Universitari de Bellvitge
City
L'Hospitalet de Llobregat
State/Province
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Josep Torremadé, MD, PhD
Phone
932607500
Ext
2747
Email
jtorremade@bellvitgehospital.cat
First Name & Middle Initial & Last Name & Degree
Begoña Etcheverry, MD
Phone
932607500
Ext
2747
Email
betcheverry@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
Early Shockwave Therapy for Post-RP ED
We'll reach out to this number within 24 hrs