Trial Outcomes & Findings for Pivotal Study to Assess the Safety and Effectiveness of the iTind Device (NCT NCT02506465)

NCT ID: NCT02506465

Last Updated: 2022-02-28

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 185 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2022-02-28

Participant Flow

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.

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.

Participant milestones

Measure	iTind Arm iTind implant is implant during the study for 5-7 days. iTIND: Temporary Implantable Nitinol Device (iTIND)	Sham Arm Foley catheter is used during the study Sham Arm: Foley catheter will be placed and immediately removed.
Overall Study STARTED	128	57
Overall Study COMPLETED	78	57
Overall Study NOT COMPLETED	50	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	iTind Arm n=128 Participants iTind implant is implant during the study for 5-7 days. iTIND: Temporary Implantable Nitinol Device (iTIND)	Sham Arm n=57 Participants Foley catheter is used during the study Sham Arm: Foley catheter will be placed and immediately removed.	Total n=185 Participants Total of all reporting groups
Age, Customized	61.5 years STANDARD_DEVIATION 6.5 • n=128 Participants	60.1 years STANDARD_DEVIATION 6.3 • n=57 Participants	61.1 years STANDARD_DEVIATION 6.5 • n=185 Participants
Sex: Female, Male Female	0 Participants n=128 Participants	0 Participants n=57 Participants	0 Participants n=185 Participants
Sex: Female, Male Male	128 Participants n=128 Participants	57 Participants n=57 Participants	185 Participants n=185 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=128 Participants	0 Participants n=57 Participants	2 Participants n=185 Participants
Race (NIH/OMB) Asian	1 Participants n=128 Participants	2 Participants n=57 Participants	3 Participants n=185 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=128 Participants	1 Participants n=57 Participants	1 Participants n=185 Participants
Race (NIH/OMB) Black or African American	23 Participants n=128 Participants	11 Participants n=57 Participants	34 Participants n=185 Participants
Race (NIH/OMB) White	86 Participants n=128 Participants	36 Participants n=57 Participants	122 Participants n=185 Participants
Race (NIH/OMB) More than one race	16 Participants n=128 Participants	7 Participants n=57 Participants	23 Participants n=185 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=128 Participants	0 Participants n=57 Participants	0 Participants n=185 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
IPSS score	22.1 units on a scale STANDARD_DEVIATION 6.8 • n=128 Participants	22.8 units on a scale STANDARD_DEVIATION 6.2 • n=57 Participants	22.3 units on a scale STANDARD_DEVIATION 6.6 • n=185 Participants
Qmax	8.7 ml/sec STANDARD_DEVIATION 3.3 • n=128 Participants	8.5 ml/sec STANDARD_DEVIATION 2.4 • n=57 Participants	8.6 ml/sec STANDARD_DEVIATION 3.0 • n=185 Participants
PVR	61.6 ml STANDARD_DEVIATION 55.5 • n=128 Participants	61.9 ml STANDARD_DEVIATION 54.2 • n=57 Participants	61.6 ml STANDARD_DEVIATION 55.0 • n=185 Participants
QoL	4.6 units on a scale STANDARD_DEVIATION 1.3 • n=128 Participants	4.9 units on a scale STANDARD_DEVIATION 1.0 • n=57 Participants	4.6 units on a scale STANDARD_DEVIATION 1.2 • n=185 Participants
IIEF questionnaire	38.3 units on a scale STANDARD_DEVIATION 20.7 • n=128 Participants	39.1 units on a scale STANDARD_DEVIATION 19.6 • n=57 Participants	38.5 units on a scale STANDARD_DEVIATION 20.3 • n=185 Participants
SHIM questionnaire	13.2 units on a scale STANDARD_DEVIATION 7.3 • n=128 Participants	14.2 units on a scale STANDARD_DEVIATION 6.6 • n=57 Participants	13.5 units on a scale STANDARD_DEVIATION 7.0 • n=185 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	iTind Arm n=128 Participants iTind implant is implant during the study for 5-7 days. iTIND: Temporary Implantable Nitinol Device (iTIND)	Sham Arm n=57 Participants Foley catheter is used during the study Sham Arm: Foley catheter will be placed and immediately removed.
Month 3 Results in the IPSS Score in Both Arms.	12.57 score on a scale Standard Deviation 6.95	15.8 score on a scale Standard Deviation 9.0

SECONDARY outcome

Timeframe: 3 months

Month 3 results in Qmax (maximum urinary flow rate)

Outcome measures

Measure	iTind Arm n=128 Participants iTind implant is implant during the study for 5-7 days. iTIND: Temporary Implantable Nitinol Device (iTIND)	Sham Arm n=57 Participants Foley catheter is used during the study Sham Arm: Foley catheter will be placed and immediately removed.
Qmax Measurement	13.55 ml/sec Standard Deviation 6.4	11.4 ml/sec Standard Deviation 5.3

SECONDARY outcome

Timeframe: 3 months

Month 3 results in PVR (post-void residual urine volume)

Outcome measures

Measure	iTind Arm n=128 Participants iTind implant is implant during the study for 5-7 days. iTIND: Temporary Implantable Nitinol Device (iTIND)	Sham Arm n=57 Participants Foley catheter is used during the study Sham Arm: Foley catheter will be placed and immediately removed.
PVR	59.44 ml Standard Deviation 56.43	66.9 ml Standard Deviation 65.1

SECONDARY outcome

Timeframe: 3 months

The International Index of Erectile Function score. Scale: minimum 6, maximum 75. Higher values are better. Month 3 results in IIEF.

Outcome measures

Measure	iTind Arm n=128 Participants iTind implant is implant during the study for 5-7 days. iTIND: Temporary Implantable Nitinol Device (iTIND)	Sham Arm n=57 Participants Foley catheter is used during the study Sham Arm: Foley catheter will be placed and immediately removed.
IIEF Questionnaire	43.52 score on a scale Standard Deviation 22.24	40.5 score on a scale Standard Deviation 22.8

SECONDARY outcome

Timeframe: 3 months

The Sexual Health Inventory for Men questionnaire. Scale: minimum 1, maximum 25. Higher values are better. Month 3 results in SHIM.

Outcome measures

Measure	iTind Arm n=128 Participants iTind implant is implant during the study for 5-7 days. iTIND: Temporary Implantable Nitinol Device (iTIND)	Sham Arm n=57 Participants Foley catheter is used during the study Sham Arm: Foley catheter will be placed and immediately removed.
SHIM	13.7 score on a scale Standard Deviation 7.76	13.2 score on a scale Standard Deviation 7.9

Adverse Events

iTind Arm

Serious events: 10 serious events

Other events: 45 other events

Deaths: 1 deaths

Sham Arm

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	iTind Arm n=128 participants at risk iTind implant is implant during the study for 5-7 days. Temporary Implantable Nitinol Device (iTIND).	Sham Arm n=57 participants at risk Foley catheter is used during the study. Foley catheter will be placed and immediately removed.
Renal and urinary disorders Urinary retention	1.6% 2/128 • Number of events 16 • Adverse Events were documented from implantation day until the first follow up visit at 3 months. AEs and SAEs defined in the same manner as clinicaltrials.gov.	0.00% 0/57 • Adverse Events were documented from implantation day until the first follow up visit at 3 months. AEs and SAEs defined in the same manner as clinicaltrials.gov.
Infections and infestations Urinary tract infection	1.6% 2/128 • Number of events 16 • Adverse Events were documented from implantation day until the first follow up visit at 3 months. AEs and SAEs defined in the same manner as clinicaltrials.gov.	0.00% 0/57 • Adverse Events were documented from implantation day until the first follow up visit at 3 months. AEs and SAEs defined in the same manner as clinicaltrials.gov.
Renal and urinary disorders Acute renal failure	0.78% 1/128 • Number of events 16 • Adverse Events were documented from implantation day until the first follow up visit at 3 months. AEs and SAEs defined in the same manner as clinicaltrials.gov.	0.00% 0/57 • Adverse Events were documented from implantation day until the first follow up visit at 3 months. AEs and SAEs defined in the same manner as clinicaltrials.gov.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic cancer	0.78% 1/128 • Number of events 16 • Adverse Events were documented from implantation day until the first follow up visit at 3 months. AEs and SAEs defined in the same manner as clinicaltrials.gov.	0.00% 0/57 • Adverse Events were documented from implantation day until the first follow up visit at 3 months. AEs and SAEs defined in the same manner as clinicaltrials.gov.
General disorders General weakness	1.6% 2/128 • Number of events 16 • Adverse Events were documented from implantation day until the first follow up visit at 3 months. AEs and SAEs defined in the same manner as clinicaltrials.gov.	0.00% 0/57 • Adverse Events were documented from implantation day until the first follow up visit at 3 months. AEs and SAEs defined in the same manner as clinicaltrials.gov.
Gastrointestinal disorders Nausea and vomiting	1.6% 2/128 • Number of events 16 • Adverse Events were documented from implantation day until the first follow up visit at 3 months. AEs and SAEs defined in the same manner as clinicaltrials.gov.	0.00% 0/57 • Adverse Events were documented from implantation day until the first follow up visit at 3 months. AEs and SAEs defined in the same manner as clinicaltrials.gov.
Psychiatric disorders Depression, suicidal and self-injurious behavior	1.6% 2/128 • Number of events 16 • Adverse Events were documented from implantation day until the first follow up visit at 3 months. AEs and SAEs defined in the same manner as clinicaltrials.gov.	0.00% 0/57 • Adverse Events were documented from implantation day until the first follow up visit at 3 months. AEs and SAEs defined in the same manner as clinicaltrials.gov.
Infections and infestations Abscess and sepsis	1.6% 2/128 • Number of events 16 • Adverse Events were documented from implantation day until the first follow up visit at 3 months. AEs and SAEs defined in the same manner as clinicaltrials.gov.	0.00% 0/57 • Adverse Events were documented from implantation day until the first follow up visit at 3 months. AEs and SAEs defined in the same manner as clinicaltrials.gov.
Vascular disorders Deep vein thrombosis (DVT) of legs	0.78% 1/128 • Number of events 16 • Adverse Events were documented from implantation day until the first follow up visit at 3 months. AEs and SAEs defined in the same manner as clinicaltrials.gov.	0.00% 0/57 • Adverse Events were documented from implantation day until the first follow up visit at 3 months. AEs and SAEs defined in the same manner as clinicaltrials.gov.
Injury, poisoning and procedural complications Shoulder fracture	0.78% 1/128 • Number of events 16 • Adverse Events were documented from implantation day until the first follow up visit at 3 months. AEs and SAEs defined in the same manner as clinicaltrials.gov.	0.00% 0/57 • Adverse Events were documented from implantation day until the first follow up visit at 3 months. AEs and SAEs defined in the same manner as clinicaltrials.gov.
Gastrointestinal disorders Abdominal pain	0.00% 0/128 • Adverse Events were documented from implantation day until the first follow up visit at 3 months. AEs and SAEs defined in the same manner as clinicaltrials.gov.	1.8% 1/57 • Number of events 2 • Adverse Events were documented from implantation day until the first follow up visit at 3 months. AEs and SAEs defined in the same manner as clinicaltrials.gov.
Nervous system disorders Central nervous system vascular disorders	0.00% 0/128 • Adverse Events were documented from implantation day until the first follow up visit at 3 months. AEs and SAEs defined in the same manner as clinicaltrials.gov.	1.8% 1/57 • Number of events 2 • Adverse Events were documented from implantation day until the first follow up visit at 3 months. AEs and SAEs defined in the same manner as clinicaltrials.gov.

Other adverse events

Measure	iTind Arm n=128 participants at risk iTind implant is implant during the study for 5-7 days. Temporary Implantable Nitinol Device (iTIND).	Sham Arm n=57 participants at risk Foley catheter is used during the study. Foley catheter will be placed and immediately removed.
Renal and urinary disorders Dysuria	21.1% 27/128 • Number of events 109 • Adverse Events were documented from implantation day until the first follow up visit at 3 months. AEs and SAEs defined in the same manner as clinicaltrials.gov.	8.8% 5/57 • Number of events 19 • Adverse Events were documented from implantation day until the first follow up visit at 3 months. AEs and SAEs defined in the same manner as clinicaltrials.gov.
Renal and urinary disorders Hematuria	12.5% 16/128 • Number of events 109 • Adverse Events were documented from implantation day until the first follow up visit at 3 months. AEs and SAEs defined in the same manner as clinicaltrials.gov.	0.00% 0/57 • Adverse Events were documented from implantation day until the first follow up visit at 3 months. AEs and SAEs defined in the same manner as clinicaltrials.gov.
Infections and infestations Urinary tract infection	1.6% 2/128 • Number of events 109 • Adverse Events were documented from implantation day until the first follow up visit at 3 months. AEs and SAEs defined in the same manner as clinicaltrials.gov.	0.00% 0/57 • Adverse Events were documented from implantation day until the first follow up visit at 3 months. AEs and SAEs defined in the same manner as clinicaltrials.gov.

Additional Information

Sivan Baker

Medi-Tate / Olympus

Phone: +97247701839

Email: sivan.baker@olympus.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place