Benign Prostate Hyperplasia
Conditions
Brief summary
The study objectives are to demonstrate the efficacy and safety of the Medi-Tate iTIND as compared to control group (catheter only).
Detailed description
Medi-Tate i-Temporary Implantable Nitinol Device (iTind) is intended to treat subjects with symptomatic BPH. A total of 150 subjects with symptomatic BPH will be enrolled into this study, according to eligibility criteria. Study duration is 12 months and includes 7 visits: screening, screening follow up, implantation, retrieval, 6 weeks follow up, 3 months follow up and 12 months follow up. iTind Device will be implanted for 5-7 days. Sham will be a routine Foley catheter procedure.
Interventions
Sponsors
Medi-Tate Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Subject signed informed consent form (ICF) 2. Age 50 and above 3. Male with symptomatic BPH. 4. IPSS symptom severity score ≥ 10 5. Peak urinary flow of \< 12 ml/sec . Meeting the criterion on (2) two separate voiding trials , on a minimum voided volume of at least 125 cc for each voiding trial. 6. Prostate volume between 25 ml to 75 ml (assessed by ultrasound) 7. Blood CBC and biochemistry up to two weeks before screening demonstrating: Normal values of the PT, PTT and INR tests (anticoagulants should be stopped according to GCP) 8. Subject able to comply with the study protocol 9. Normal Urinalysis and urine culture
Exclusion criteria
1. Cardiac arrhythmias, cardiac disease including congestive heart failure, uncontrolled diabetes mellitus, significant respiratory disease, or known immunosuppression; 2. Neurogenic bladder and/or sphincter abnormalities due to Parkinson's disease, multiple sclerosis, cerebral vascular accident, diabetes 3. A post void residual (PVR) volume \> 250 ml measured by ultrasound or acute urinary retention 4. Compromised renal function (i.e., serum creatinine level \> 1.8 mg/dl, or upper tract disease); 5. Confirmed or suspected bladder cancer; 6. Recent (within 3 months) cystolithiasis or hematuria; 7. Urethral strictures, bladder neck contracture, urinary bladder stones or other potentially confounding bladder pathology; 8. An active urinary tract infection. 9. Enrolled in another treatment trial for any disease within the past 30 days. 10. Previous colo- rectal surgery (other than hemorrhoidectomy) or history of rectal disease if the therapy may potentially cause injury to sites of previous rectal surgery, e.g., if a transrectal probe is used; 11. Previous pelvic irradiation, cryosurgery or radical pelvic surgery; 12. Previous prostate surgery, balloon dilatation, stent implantation, laser prostatectomy, hyperthermia, or any other invasive treatment to the prostate 13. History of prostatitis within the past 5 years. 14. Median lobe obstruction of the prostate. 15. Cancer that is not considered cured, except basal cell or squamous cell carcinoma of the skin (cured defined as no evidence of cancer within the past 5 years). 16. Any serious medical condition likely to impede successful completion of the study 17. Participating in any other investigational study for either drug or device which can influence collection of valid data under this study. 18. Subjects who are actively taking medications that affects urination and BPH symptoms not completing the required washout period. 19. Baseline PSA ≥ 10 ng/ml. 20. Positive DRE. 21. Baseline PSA between 2.5-10 ng/ml and free PSA \< 25%, without a subsequent negative prostate biopsy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Month 3 Results in the IPSS Score in Both Arms. | 3 months | Month 3 results in the IPSS Score in both arms IPSS - The International Prostate Symptom Score. Scale: minimum 0 (zero), maximum 35. Lower values are better. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Qmax Measurement | 3 months | Month 3 results in Qmax (maximum urinary flow rate) |
| PVR | 3 months | Month 3 results in PVR (post-void residual urine volume) |
| IIEF Questionnaire | 3 months | The International Index of Erectile Function score. Scale: minimum 6, maximum 75. Higher values are better. Month 3 results in IIEF. |
| SHIM | 3 months | The Sexual Health Inventory for Men questionnaire. Scale: minimum 1, maximum 25. Higher values are better. Month 3 results in SHIM. |
Countries
Canada, United States
Participant flow
Recruitment details
Sixteen centers participated in the study (14 in the United States, 2 in Canada) between July 2015 and October 2018. First patient was recruited on July 2015.
Pre-assignment details
All patients on BPH related medications started a wash-out period prior to implantation: 1 month for alpha-blockers and 6 months for 5-alpha-reductase inhibitors (5-ARIs). Medication naïve patients seeking treatment refused medication in preference for a minimally invasive surgical technique.
Participants by arm
| Arm | Count |
|---|---|
| iTind Arm iTind implant is implant during the study for 5-7 days.
iTIND: Temporary Implantable Nitinol Device (iTIND) | 128 |
| Sham Arm Foley catheter is used during the study
Sham Arm: Foley catheter will be placed and immediately removed. | 57 |
| Total | 185 |
Baseline characteristics
| Characteristic | iTind Arm | Sham Arm | Total |
|---|---|---|---|
| Age, Customized | 61.5 years STANDARD_DEVIATION 6.5 | 60.1 years STANDARD_DEVIATION 6.3 | 61.1 years STANDARD_DEVIATION 6.5 |
| IIEF questionnaire | 38.3 units on a scale STANDARD_DEVIATION 20.7 | 39.1 units on a scale STANDARD_DEVIATION 19.6 | 38.5 units on a scale STANDARD_DEVIATION 20.3 |
| IPSS score | 22.1 units on a scale STANDARD_DEVIATION 6.8 | 22.8 units on a scale STANDARD_DEVIATION 6.2 | 22.3 units on a scale STANDARD_DEVIATION 6.6 |
| PVR | 61.6 ml STANDARD_DEVIATION 55.5 | 61.9 ml STANDARD_DEVIATION 54.2 | 61.6 ml STANDARD_DEVIATION 55 |
| Qmax | 8.7 ml/sec STANDARD_DEVIATION 3.3 | 8.5 ml/sec STANDARD_DEVIATION 2.4 | 8.6 ml/sec STANDARD_DEVIATION 3 |
| QoL | 4.6 units on a scale STANDARD_DEVIATION 1.3 | 4.9 units on a scale STANDARD_DEVIATION 1 | 4.6 units on a scale STANDARD_DEVIATION 1.2 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 23 Participants | 11 Participants | 34 Participants |
| Race (NIH/OMB) More than one race | 16 Participants | 7 Participants | 23 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 86 Participants | 36 Participants | 122 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 128 Participants | 57 Participants | 185 Participants |
| SHIM questionnaire | 13.2 units on a scale STANDARD_DEVIATION 7.3 | 14.2 units on a scale STANDARD_DEVIATION 6.6 | 13.5 units on a scale STANDARD_DEVIATION 7 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 128 | 0 / 57 |
| other Total, other adverse events | 45 / 128 | 5 / 57 |
| serious Total, serious adverse events | 10 / 128 | 2 / 57 |
Outcome results
Primary
Month 3 Results in the IPSS Score in Both Arms.
Month 3 results in the IPSS Score in both arms IPSS - The International Prostate Symptom Score. Scale: minimum 0 (zero), maximum 35. Lower values are better.
Time frame: 3 months
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| iTind Arm | Month 3 Results in the IPSS Score in Both Arms. | 12.57 score on a scale | Standard Deviation 6.95 |
| Sham Arm | Month 3 Results in the IPSS Score in Both Arms. | 15.8 score on a scale | Standard Deviation 9 |
Secondary
IIEF Questionnaire
The International Index of Erectile Function score. Scale: minimum 6, maximum 75. Higher values are better. Month 3 results in IIEF.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iTind Arm | IIEF Questionnaire | 43.52 score on a scale | Standard Deviation 22.24 |
| Sham Arm | IIEF Questionnaire | 40.5 score on a scale | Standard Deviation 22.8 |
Secondary
PVR
Month 3 results in PVR (post-void residual urine volume)
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iTind Arm | PVR | 59.44 ml | Standard Deviation 56.43 |
| Sham Arm | PVR | 66.9 ml | Standard Deviation 65.1 |
Secondary
Qmax Measurement
Month 3 results in Qmax (maximum urinary flow rate)
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iTind Arm | Qmax Measurement | 13.55 ml/sec | Standard Deviation 6.4 |
| Sham Arm | Qmax Measurement | 11.4 ml/sec | Standard Deviation 5.3 |
Secondary
SHIM
The Sexual Health Inventory for Men questionnaire. Scale: minimum 1, maximum 25. Higher values are better. Month 3 results in SHIM.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iTind Arm | SHIM | 13.7 score on a scale | Standard Deviation 7.76 |
| Sham Arm | SHIM | 13.2 score on a scale | Standard Deviation 7.9 |