Erectile Dysfunction Following Radical ProstatectomyNCT03905057
Early Shockwave Therapy for Post-RP ED
A study testing Dornier Aries 2 (with active applicator) in people with Erectile Dysfunction Following Radical Prostatectomy, run by Dornier MedTech Systems at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 to 65 years, men only
- Conditions the study is for
- Erectile Dysfunction Following Radical Prostatectomy
- What is being tested?
- Dornier Aries 2 (with active applicator)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteSpain
- Study dates
- 26 Mar 2018to Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona
Josep Torremadé, MD, PhD, 932607500 ext. 2747, jtorremade@bellvitgehospital.cat
Begoña Etcheverry, MD, 932607500 ext. 2747, betcheverry@hotmail.com
About this study
Official title: Effect of Early Shockwave Therapy Protocol for Preservation and Restoration of Erectile Function After Nerve-sparing Radical Prostatectomy
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).
Read the 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.
- Being tested
- Dornier Aries 2 (with active applicator), Dornier Aries 2 (with sham applicator)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dornier Aries 2 (with active applicator)Device
Active ESWT: 5000 shockwaves per session. 2 ESWT sessions per week, 12 sessions in total.
Dornier Aries 2 (with sham applicator)Device
Sham ESWT - No shockwave administered
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Dornier Aries 2 (with active applicator) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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
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).
Measured: 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
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)
Measured: 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
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.
Measured: 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
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.
Measured: 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
The flaccid penis of each patient will be stretched and measured from the base of the penis to the tip of the glans.
Measured: baseline, 12-weeks post-RP, 24-weeks post-RP, 52-weeks post-RP, 18-months post-RP and 24-months post-RP
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.
Measured: First treatment session, 12-weeks post-RP, 24-weeks post-RP, 52-weeks post-RP, 18-months post-RP and 24-months post-RP
Oncologic status
The oncologic status of each patient will be evaluated determined by the serum prostate specific antigen (PSA) levels.
Measured: 12-weeks post-RP, 24-weeks post-RP, 52-weeks post-RP, 18-months post-RP and 24-months post-RP
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.
Measured: 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
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.
Measured: ICI visits, 52-weeks post-RP, 18-months post-RP and 24-months post-RP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2019
- Study start26 Mar 2018
- Primary completionJun 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile Dysfunction Following Radical ProstatectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dornier MedTech Systems
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital Universitari de Bellvitge
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03905057
- Sponsor's protocol ID
- EspPRP-ED_001
- Status last verified
- Apr 2019
- First submitted
- 26 Mar 2019
- Last updated
- 8 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Early Shockwave Therapy Protocol for Preservation and Restoration of Erectile Function After Nerve-sparing Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT03905057
- Acronym / sponsor ID
- EspPRP-ED_001
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Dornier MedTech SystemsIndustry (pharma, biotech, devices)
- Collaborators
- Hospital Universitari de Bellvitge
- Study start
- 26 Mar 2018 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 5 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham ESWT + 5mg Tadalafil | Sham comparator | Device: Dornier Aries 2 (with sham applicator)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. |
| Active ESWT + 5mg Tadalafil | Active comparator | Device: Dornier Aries 2 (with active applicator)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. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Men scheduled for robotic bilateral nerve-sparing radical prostatectomy
- Diagnosed with low/intermediate-risk prostate cancer:
- Baseline IIEF-ED 22-30 without erectogenic aids
- No urinary incontinence (no usage of urinary pads)
- Sexually active, in a stable heterosexual relationship
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dornier Aries 2 (with active applicator)Active ESWT: 5000 shockwaves per session. 2 ESWT sessions per week, 12 sessions in total. | Device | Active ESWT + 5mg Tadalafil |
| Dornier Aries 2 (with sham applicator)Sham ESWT - No shockwave administered | Device | Sham ESWT + 5mg Tadalafil |
Primary outcome
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
Time frame: 28-week follow up visit
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
Time frame: 24-month follow up visit
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)
9 secondary outcomes
Proportion of patients achieving Erectile Function (EF) domain score of the International Index of Erectile Function (IIEF) of 22-30 in each group
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
Change in each domain of the full International Index of Erectile Function (IIEF) score
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
Change in Erection Hardness Score
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
Change in Global Assessment Questionnaire (GAQ) score
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
Change in stretched flaccid penile length
Time frame: baseline, 12-weeks post-RP, 24-weeks post-RP, 52-weeks post-RP, 18-months post-RP and 24-months post-RP
Change in degree of incontinence
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
Oncologic status
Time frame: 12-weeks post-RP, 24-weeks post-RP, 52-weeks post-RP, 18-months post-RP and 24-months post-RP
Time to recovery of penetration erection hardness without erectogenic aids
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
Tolerability to and reliance on intracavernosal injections for satisfactory erections: Visual Analog Scale for Pain
Time frame: ICI visits, 52-weeks post-RP, 18-months post-RP and 24-months post-RP
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dornier Aries 2 (with active applicator) in people with Erectile Dysfunction Following Radical Prostatectomy, run by Dornier MedTech Systems at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Josep Torremadé, MD, PhD (+34 932607500 ext. 2747, jtorremade@bellvitgehospital.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 28-week follow up visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2019.