MT-08: A Randomized, International Study to Assess the Safety of iTind Compared to TURP
Study Details
Study Description
Brief Summary
The study objective is to demonstrate the safety of the iTind as compared to the TURP arm and to further evaluate the efficacy of iTind vs. TURP in terms of subjective and functional results.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Transurethral resection of the prostate (TURP) is the gold standard treatment for relieving lower urinary tract symptoms (LUTS) secondary to benign Prostatic Hyperplasia (BPH). This surgery has proven to have high efficacy with regards to improving objective and subjective parameters, however it is associated with significant morbidity, lengthy recovery period and long-term complications. The iTind is a minimally invasive temporary device designed to relieve LUTS secondary to BPH. This study is designed to compare the minimally invasive iTind device to TURP.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: iTind arm The iTind is a minimally invasive temporary implant |
Device: iTind
The iTind is implemented for 5-7 days
|
| Experimental: TURP arm Transurethral Resection of the Prostate |
Procedure: TURP
TURP is a surgical procedure which removes prostatic tissue by electrocautery dissection
|
Outcome Measures
Primary Outcome Measures
- Primary Safety [3 months]
Rate of Adverse events Clavien Dindo grade II or higher
- Primary Safety [3 months]
Rate of Adverse events Clavien Dindo grade I resulting in persistent disability
Secondary Outcome Measures
- Secondary Efficacy [12 months]
Rate of International Prostate Symptom Score (IPSS) (lower scores mean a better outcome)
- Secondary Efficacy [12 months]
Rate of Benign Prostatic Hyperplasia Impact Index (BPHII) (lower scores mean a better outcome)
- Secondary Efficacy [12 months]
Rate of Sexual Health Inventory for Men (SHIM) (lower scores mean a better outcome)
- Secondary Efficacy [12 months]
Rate of Male Sexual Health Questionnaire for assessing ejaculatory dysfunction (MSHQ-EjD) (higher scores mean a better outcome)
- Secondary Efficacy [12 months]
Return to daily life questionnaire
- Secondary Efficacy [12 months]
Rate of Patient Global Impression of Improvement (PGI-I) (lower scores mean a better outcome)
- Secondary Efficacy [12 months]
Work Productivity and Activity Impairment questionnaire (WPAI)
- Secondary Efficacy [30 days]
Rate of Quality of Recovery (Visual Analog Score for pain)
- Secondary Efficacy [12 months]
Rate of partner questionnaire (higher scores mean a better outcome)
- Secondary Efficacy [12 months]
Rate of Incontinence Severity Index (ISI) (lower scores mean a better outcome)
- Secondary Efficacy [12 months]
Peak urinary rate (ml/sec)
- Secondary Efficacy [12 months]
Post-Void Residual (PVR) urine volume (ml)
- Secondary Efficacy [12 months]
Time to first AE (days)
- Secondary Efficacy [12 months]
Blood transfusion rate (cases)
- Secondary Efficacy [12 months]
OR and procedure times (minutes)
- Secondary Efficacy [12 months]
Anesthesia type during the procedure
- Secondary Efficacy [12 months]
Irrigation fluids rate (cases)
- Secondary Efficacy [12 months]
Hospitalization (days)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subject has diagnosis of lower urinary tract symptoms due to benign prostatic enlargement causing bladder outlet obstruction
-
Subject is willing to be randomized
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Subject is mentally capable and willing to sign a study-specific informed consent form
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Subject is willing and able to comply with all study requirements
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Age from 45 through 80 years
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Subject has medical record documentation of a prostate volume up to 60mL (inclusive) by Transrectal Ultrasound (TRUS) (If TRUS testing documentation is available from less than 90 days prior to the informed consent date and the prostate volume is up to 60mL, it may be used for the inclusion/exclusion criteria)
-
Subject has an IPSS urinary symptoms score greater than or equal to 13 measured at the baseline visit
-
Subject has medical record documentation of a maximum urinary flow rate (Qmax) ≤15mL/s and ≥5mL/s (If uroflow testing documentation is available within 90 days prior to the informed consent date, and the sample is greater than or equal to 120mL, and the Qmax is ≤15mL/s and ≥5mL/s, it may be used for the inclusion/exclusion criteria)
-
Subject has a serum creatinine that is within the normal range for the laboratory at the study center (or documentation of clinical insignificance in the subject's medical record by the investigator if outside the normal range) and measured ≤ 30 days prior to the date of surgery
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History of inadequate response, contraindication, or refusal to medical therapy
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Blood CBC and biochemistry up to two weeks before screening demonstrating: Normal values of the PT, PTT and INR tests
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Normal Urinalysis and urine culture
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Sexually active within 6 months before the index procedure
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Sexual Health Inventory for Men score >6
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Positive response to MSHQ-EjD (excluding the response ''Could not ejaculate'')
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Incontinence Severity Index score >4.
Exclusion Criteria:
-
BMI ≥ 42
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History of prostate cancer or current/suspected bladder cancer
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Prostate cancer should be ruled out before participation to the satisfaction of the investigator if PSA is above acceptable thresholds
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Subjects with a history of actively treated bladder cancer within the past two (2) years
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Neurogenic bladder as confirmed by urodynamics or other neurological disorder that affects bladder function
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Diagnosis of polyneuropathy
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Bladder calculus or clinically significant bladder diverticulum (e.g., pouch size >20% of full bladder size)
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Active infection, including urinary tract infection
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Prostatitis treated with antibiotics within 1 year of enrollment
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Diagnosis of or has received treatment for chronic prostatitis or chronic pelvic pain syndrome (e.g. nonbacterial chronic prostatitis)
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Ever been diagnosed with a urethral stricture, meatal stenosis, or bladder neck contracture
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Subject has damage to external urinary sphincter
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Subject has diagnosis of stress urinary incontinence that requires treatment or daily pad or device use
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PVR > 250 mL
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Urinary retention at time of enrollment or subject has been catheterized in the 14 days prior to the surgical procedure
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Subject has a history of intermittent self-catheterization
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Previous prostate surgery or history of other lower urinary tract surgery such as e.g. urinary diversion, artificial urinary sphincter or penile prosthesis
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Subjects on anticoagulants (if medication cannot be stopped before and after procedure) or known coagulopathy (except aspirin below 100mg/d)
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Any severe illness that would prevent complete study participation or confound study results
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Serious concurrent medical conditions such as heart disease (e.g., myocardial infarction within 30 days prior to the date of informed consent, congestive heart failure - NYHA IV), pulmonary disease or uncontrolled diabetes
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Has had an open heart surgery, or cardiac arrest < 180 days prior to the date of informed consent
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Heart surgery, or cardiac arrest < 180 days prior to the date of informed consent
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Participants using systemic immune-suppressants including corticosteroids; unable to withhold non-steroidal anti-inflammatory agents (NSAIDs, including aspirin) for 3-5 days prior to treatment except for low dose aspirin (e.g. less than or equal to 100mg)
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Known illicit substance abuse
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Participants using anticholinergics specifically for bladder problems. Use of medications with anticholinergic properties is allowable provided the patient does not have documented adverse urinary side effects from these medications
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Dementia or psychiatric condition that prevents the participant from completing required follow up
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Contraindication to general or spinal anesthesia
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Previous pelvic radiotherapy
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Participating in another investigational study that could affect responses to the study device
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Subject has any other disease or condition(s) that would interfere with completion of the study and follow up assessments, would increase risks of the procedure, or in the judgment of the investigator would potentially interfere with compliance to this study or would adversely affect outcomes
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Subject is unwilling to accept a transfusion should one be required
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Median lobe obstruction of the prostate as assessed by TRUS
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Known allergy to nickel
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Unwilling to report sexual function.
Intraoperative Exclusion Criteria:
Median lobe obstruction or any abnormal findings on cystoscopy at the time of implantation that can interfere with iTind implantation or TURP procedure
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Olympus Corporation of the Americas
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- MT-08