Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
94 participants
INTERVENTIONAL
2018-03-26
2021-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Sham ESWT + 5mg Tadalafil
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.
Dornier Aries 2 (with sham applicator)
Sham ESWT - No shockwave administered
Active ESWT + 5mg Tadalafil
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.
Dornier Aries 2 (with active applicator)
Active ESWT: 5000 shockwaves per session. 2 ESWT sessions per week, 12 sessions in total.
Interventions
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Dornier Aries 2 (with active applicator)
Active ESWT: 5000 shockwaves per session. 2 ESWT sessions per week, 12 sessions in total.
Dornier Aries 2 (with sham applicator)
Sham ESWT - No shockwave administered
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
50 Years
65 Years
MALE
No
Sponsors
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Hospital Universitari de Bellvitge
OTHER
Dornier MedTech Systems
INDUSTRY
Responsible Party
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Locations
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Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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EspPRP-ED_001
Identifier Type: -
Identifier Source: org_study_id
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