Trial Outcomes & Findings for A Clinical Study to Evaluate the Clinical Performance and Safety of LiquiBand FIX8® Versus AbsorbaTack™ for Hernia Mesh Fixation and Peritoneal Closure in Groin Hernia Repair (NCT NCT04009213)

Last Updated: 2024-01-11

Results Overview

Change in pain from baseline to 6 month will be assessed and compared to treatment with AbsorbaTack™ in subjects requiring laparoscopic (TEP and TAPP) hernia repair where the VAS value is 0 - 10, 0 = no pain and 10 = worst pain imaginable.

Recruitment status

COMPLETED

Study phase

Target enrollment

284 participants

Primary outcome timeframe

Assessed at pre-surgery (baseline), day 7, day 14, month 1, month 3 and month 6 post surgery. Change from baseline at month 6 reported.

Results posted on

2024-01-11

Participant Flow

Between August 2019 and December 2021, 329 patients were screened and consented for laparoscopic groin (femoral and inguinal). Of those Subjects 142 were randomized to LiquiBand Fix8 and 142 were randomized to AbsorbaTack for mesh fixation and peritoneal closure (in the case of TAPP).

Participant milestones

Participant milestones
Measure	LiquiBand FIX8® Subjects requiring laparoscopic (TEP and TAPP) hernia repair were randomized to LiquiBand FIX8®, for mesh fixation and peritoneal closure (in the case of TAPP).	AbsorbaTack™ Subjects requiring laparoscopic (TEP and TAPP) hernia repair were randomized to AbsorbaTack™ for mesh fixation and peritoneal closure (in the case of TAPP).
Overall Study STARTED	142	142
Overall Study COMPLETED	132	134
Overall Study NOT COMPLETED	10	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The overall population differs for the AbsorbaTack™ group as n=1 patient did not provide a population description.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LiquiBand FIX8® n=142 Participants Groin Hernia Study Arm with LiquiBand FIX8® as treatment	AbsorbaTack™ n=142 Participants Groin Hernia Study Arm with AbsorbaTack™ as treatment	Total n=284 Participants Total of all reporting groups
Sex: Female, Male Female	10 Participants n=142 Participants	4 Participants n=142 Participants	14 Participants n=284 Participants
Sex: Female, Male Male	132 Participants n=142 Participants	138 Participants n=142 Participants	270 Participants n=284 Participants
Age, Continuous	59.41 years STANDARD_DEVIATION 13.696 • n=142 Participants	58.47 years STANDARD_DEVIATION 14.411 • n=142 Participants	58.94 years STANDARD_DEVIATION 14.041 • n=284 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=142 Participants	4 Participants n=142 Participants	8 Participants n=284 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	138 Participants n=142 Participants	138 Participants n=142 Participants	276 Participants n=284 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=142 Participants	0 Participants n=142 Participants	0 Participants n=284 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=142 Participants • The overall population differs for the AbsorbaTack™ group as n=1 patient did not provide a population description.	0 Participants n=141 Participants • The overall population differs for the AbsorbaTack™ group as n=1 patient did not provide a population description.	0 Participants n=283 Participants • The overall population differs for the AbsorbaTack™ group as n=1 patient did not provide a population description.
Race (NIH/OMB) Asian	1 Participants n=142 Participants • The overall population differs for the AbsorbaTack™ group as n=1 patient did not provide a population description.	3 Participants n=141 Participants • The overall population differs for the AbsorbaTack™ group as n=1 patient did not provide a population description.	4 Participants n=283 Participants • The overall population differs for the AbsorbaTack™ group as n=1 patient did not provide a population description.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=142 Participants • The overall population differs for the AbsorbaTack™ group as n=1 patient did not provide a population description.	0 Participants n=141 Participants • The overall population differs for the AbsorbaTack™ group as n=1 patient did not provide a population description.	0 Participants n=283 Participants • The overall population differs for the AbsorbaTack™ group as n=1 patient did not provide a population description.
Race (NIH/OMB) Black or African American	13 Participants n=142 Participants • The overall population differs for the AbsorbaTack™ group as n=1 patient did not provide a population description.	16 Participants n=141 Participants • The overall population differs for the AbsorbaTack™ group as n=1 patient did not provide a population description.	29 Participants n=283 Participants • The overall population differs for the AbsorbaTack™ group as n=1 patient did not provide a population description.
Race (NIH/OMB) White	128 Participants n=142 Participants • The overall population differs for the AbsorbaTack™ group as n=1 patient did not provide a population description.	121 Participants n=141 Participants • The overall population differs for the AbsorbaTack™ group as n=1 patient did not provide a population description.	249 Participants n=283 Participants • The overall population differs for the AbsorbaTack™ group as n=1 patient did not provide a population description.
Race (NIH/OMB) More than one race	0 Participants n=142 Participants • The overall population differs for the AbsorbaTack™ group as n=1 patient did not provide a population description.	1 Participants n=141 Participants • The overall population differs for the AbsorbaTack™ group as n=1 patient did not provide a population description.	1 Participants n=283 Participants • The overall population differs for the AbsorbaTack™ group as n=1 patient did not provide a population description.
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=142 Participants • The overall population differs for the AbsorbaTack™ group as n=1 patient did not provide a population description.	0 Participants n=141 Participants • The overall population differs for the AbsorbaTack™ group as n=1 patient did not provide a population description.	0 Participants n=283 Participants • The overall population differs for the AbsorbaTack™ group as n=1 patient did not provide a population description.
Region of Enrollment United States	142 participants n=142 Participants	142 participants n=142 Participants	284 participants n=284 Participants

PRIMARY outcome

Timeframe: Assessed at pre-surgery (baseline), day 7, day 14, month 1, month 3 and month 6 post surgery. Change from baseline at month 6 reported.

Population: ITT population defined as all enrolled subjects. All patients for whom VAS measurements were recorded at Baseline and 6 month post surgery

Outcome measures

Outcome measures
Measure	LiquiBand FIX8® n=136 Participants Groin Hernia Study Arm with LiquiBand FIX8® as treatment	AbsorbaTack™ n=133 Participants Groin Hernia Study Arm with AbsorbaTack™ as treatment
Change in Pain	-4.9 score on a VAS scale Standard Deviation 2.5	-5.1 score on a VAS scale Standard Deviation 2.3

SECONDARY outcome

Timeframe: Assessed at week 2, month 3, month 6 and month 12 post surgery. Month 12 post surgery reported

Population: ITT population defined as all enrolled subjects. All patients who attended their follow up visit and underwent a physical examination where possible, or alternatively with self-assessment for hernia recurrence.

The incidence of hernia recurrence was assessed by physical examination and confirmed by ultrasound imaging following physical examination. Also, the study sites were guided to ask the subjects 3 questions during the clinic visit performed remotely with a 'Yes' or 'No' response; 1. Do you think your hernia has come back? 2. Do you feel or see a bulge? and 3. Do you have physical pain or symptoms at the site?

Outcome measures

Outcome measures
Measure	LiquiBand FIX8® n=141 Participants Groin Hernia Study Arm with LiquiBand FIX8® as treatment	AbsorbaTack™ n=140 Participants Groin Hernia Study Arm with AbsorbaTack™ as treatment
Number of Participants With Hernia Recurrence	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Time of surgery.

Population: All Subjects who underwent surgery with LiquiBand FIX8® or control

LiquiBand FIX8® was required to successfully fix hernia mesh at a rate non-inferior to control device (AbsorbaTack™). Successful mesh fixation did not require any additional fixation by alternate fixation device.

Outcome measures

Outcome measures
Measure	LiquiBand FIX8® n=142 Participants Groin Hernia Study Arm with LiquiBand FIX8® as treatment	AbsorbaTack™ n=142 Participants Groin Hernia Study Arm with AbsorbaTack™ as treatment
Successful Mesh Fixation at the Time of Surgery.	142 Participants	142 Participants

SECONDARY outcome

Timeframe: Time of surgery.

Population: ITT Population. Successful peritoneal closure at time of surgery was measured in all subjects undergoing TAPP hernia repair.

LiquiBand FIX8® was required to successfully approximate the peritoneum at a rate non-inferior to control device. Successful peritoneal closure did not require any additional fixation by alternate fixation device or additional procedure.

Outcome measures

Outcome measures
Measure	LiquiBand FIX8® n=94 Participants Groin Hernia Study Arm with LiquiBand FIX8® as treatment	AbsorbaTack™ n=92 Participants Groin Hernia Study Arm with AbsorbaTack™ as treatment
Incidence of Successful Peritoneal Closure (TAPP Repairs Only)	82 Participants	84 Participants

SECONDARY outcome

Timeframe: Pre-Surgery, Week 1, Week 2, Month 1, Month 3, Month 6, Month 9 and Month 12 post surgery

Population: ITT population defined as all enrolled Subjects. All patients for whom a CCS questionnaire was completed prior to surgery and at 1 week, 2 weeks, 1 month, 3 months, 6 months, 9 months and 12 months post surgery.

Quality of Life was assessed by completion of the Carolinas Comfort Scale (CCS) Questionnaire. CCS scores at each timepoint were compared between the LiquiBand FIX8® and control (AbsorbaTack) treatment groups. Carolinas Comfort Scale measures quality of life through a 23-item, Likert-type questionnaire that measures severity of pain, sensation of mesh and movement limitations in eight categories: laying down, bending over, sitting up, activities of daily living, coughing or deep breathing, walking, stairs and exercise. The subscales scores for pain (0-40), sensation of mesh (0-40) and movement limitations (0-35) are combined to provide a total CCS score. The best possible score is 0 and the worst possible score is 115.

Outcome measures

Outcome measures
Measure	LiquiBand FIX8® n=129 Participants Groin Hernia Study Arm with LiquiBand FIX8® as treatment	AbsorbaTack™ n=129 Participants Groin Hernia Study Arm with AbsorbaTack™ as treatment
Quality of Life as Measured by the Carolinas Comfort Scale (CCS). Change from 1 week to 2 weeks	-7.7 score on a scale Standard Deviation 12.4	-7.0 score on a scale Standard Deviation 13.2
Quality of Life as Measured by the Carolinas Comfort Scale (CCS). Change from 1 week to 1 month	-12.4 score on a scale Standard Deviation 12.6	-12.2 score on a scale Standard Deviation 14.6
Quality of Life as Measured by the Carolinas Comfort Scale (CCS). Change from 1 week to 3 months	-14.6 score on a scale Standard Deviation 16.9	-14.4 score on a scale Standard Deviation 15.9
Quality of Life as Measured by the Carolinas Comfort Scale (CCS). Change from 1 week to 6 months	-15.1 score on a scale Standard Deviation 16.0	-15.3 score on a scale Standard Deviation 16.7
Quality of Life as Measured by the Carolinas Comfort Scale (CCS). Change from 1 week to 9 months	-15.6 score on a scale Standard Deviation 16.3	-15.7 score on a scale Standard Deviation 16.5
Quality of Life as Measured by the Carolinas Comfort Scale (CCS). Change from 1 week to 12 months	-15.6 score on a scale Standard Deviation 16.0	-15.3 score on a scale Standard Deviation 16.1

SECONDARY outcome

Timeframe: Evaluation of pain will be measured at pre-surgery, discharge (up to 3 days), Week 1, Week 2, Month 1, Month 3, Month 6, Month 9 and Month 12 post surgery

Population: ITT population defined as all enrolled subjects. All patients for whom VAS measurements were recorded at discharge, and at 1 week, 2 weeks, 1 month, 3 months, 6 months, 9 months and 12 months post-surgery

A Visual Analog Scale (VAS) was used as a measure of pain where the VAS value is 0 - 10, 0 = no pain and 10 = worst pain imaginable.

Outcome measures

Outcome measures
Measure	LiquiBand FIX8® n=142 Participants Groin Hernia Study Arm with LiquiBand FIX8® as treatment	AbsorbaTack™ n=142 Participants Groin Hernia Study Arm with AbsorbaTack™ as treatment
Levels of Pain Experienced as Measured by Visual Analogue Scale (VAS). Change from pre-surgery to discharge	-0.3 score on a scale Standard Deviation 3.4	-0.1 score on a scale Standard Deviation 3.5
Levels of Pain Experienced as Measured by Visual Analogue Scale (VAS). Change from pre-surgery to 1 week	-1.5 score on a scale Standard Deviation 2.8	-1.5 score on a scale Standard Deviation 3.1
Levels of Pain Experienced as Measured by Visual Analogue Scale (VAS). Change from pre-surgery to 2 weeks	-2.8 score on a scale Standard Deviation 2.8	-2.7 score on a scale Standard Deviation 2.9
Levels of Pain Experienced as Measured by Visual Analogue Scale (VAS). Change from pre-surgery to 1 month	-3.2 score on a scale Standard Deviation 2.8	-3.1 score on a scale Standard Deviation 3.1
Levels of Pain Experienced as Measured by Visual Analogue Scale (VAS). Change from pre-surgery to 3 months	-3.6 score on a scale Standard Deviation 2.9	-3.4 score on a scale Standard Deviation 3.1
Levels of Pain Experienced as Measured by Visual Analogue Scale (VAS). Change from pre-surgery to 6 months	-3.6 score on a scale Standard Deviation 3.0	-3.5 score on a scale Standard Deviation 3.1
Levels of Pain Experienced as Measured by Visual Analogue Scale (VAS). Change from pre-surgery to 9 months	-3.7 score on a scale Standard Deviation 2.9	-3.5 score on a scale Standard Deviation 3.0
Levels of Pain Experienced as Measured by Visual Analogue Scale (VAS). Change from pre-surgery to 12 months	-3.6 score on a scale Standard Deviation 2.9	-3.5 score on a scale Standard Deviation 3.1

SECONDARY outcome

Timeframe: Intraoperatively, Discharge, Week 1, Week 2, Month 1, Month 3, Month 6, Month 9 and Month 12 post surgery

The number of all adverse events whether or not determined to be related to the LiquiBand FIX8® device or control device (AbsorbaTack™).

Outcome measures

Outcome measures
Measure	LiquiBand FIX8® n=142 Participants Groin Hernia Study Arm with LiquiBand FIX8® as treatment	AbsorbaTack™ n=142 Participants Groin Hernia Study Arm with AbsorbaTack™ as treatment
Safety as Measured by the Incidence of Adverse Events.	114 Adverse Events	157 Adverse Events

Adverse Events

LiquiBand FIX8®

Serious events: 11 serious events

Other events: 28 other events

Deaths: 1 deaths

AbsorbaTack™

Serious events: 16 serious events

Other events: 49 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	LiquiBand FIX8® n=142 participants at risk Subjects requiring laparoscopic (TEP and TAPP) hernia repair were randomized to LiquiBand FIX8®, for mesh fixation and peritoneal closure (in the case of TAPP).	AbsorbaTack™ n=142 participants at risk Subjects requiring laparoscopic (TEP and TAPP) hernia repair were randomized to AbsorbaTack™, for mesh fixation and peritoneal closure (in the case of TAPP).
Injury, poisoning and procedural complications Seroma	13.4% 19/142 • Adverse Event data was collected from time of randomization through 12 month follow up Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, user or other persons. A clinical occurrence means that it affects or might affect a patient's normal function.	17.6% 25/142 • Adverse Event data was collected from time of randomization through 12 month follow up Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, user or other persons. A clinical occurrence means that it affects or might affect a patient's normal function.
Injury, poisoning and procedural complications Groin Pain	2.8% 4/142 • Adverse Event data was collected from time of randomization through 12 month follow up Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, user or other persons. A clinical occurrence means that it affects or might affect a patient's normal function.	9.9% 14/142 • Adverse Event data was collected from time of randomization through 12 month follow up Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, user or other persons. A clinical occurrence means that it affects or might affect a patient's normal function.
Renal and urinary disorders Urinary Retention	3.5% 5/142 • Adverse Event data was collected from time of randomization through 12 month follow up Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, user or other persons. A clinical occurrence means that it affects or might affect a patient's normal function.	3.5% 5/142 • Adverse Event data was collected from time of randomization through 12 month follow up Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, user or other persons. A clinical occurrence means that it affects or might affect a patient's normal function.
Injury, poisoning and procedural complications Procedural Nausea	0.00% 0/142 • Adverse Event data was collected from time of randomization through 12 month follow up Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, user or other persons. A clinical occurrence means that it affects or might affect a patient's normal function.	3.5% 5/142 • Adverse Event data was collected from time of randomization through 12 month follow up Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, user or other persons. A clinical occurrence means that it affects or might affect a patient's normal function.

Additional Information

Tina Warburton, Senior Clinical Research Associate

Advanced Medical Solutions

Phone: 07791742957

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	LiquiBand FIX8® n=142 participants at risk Subjects requiring laparoscopic (TEP and TAPP) hernia repair were randomized to LiquiBand FIX8®, for mesh fixation and peritoneal closure (in the case of TAPP).	AbsorbaTack™ n=142 participants at risk Subjects requiring laparoscopic (TEP and TAPP) hernia repair were randomized to AbsorbaTack™, for mesh fixation and peritoneal closure (in the case of TAPP).
Cardiac disorders Atrial Fibrillation	0.70% 1/142 • Adverse Event data was collected from time of randomization through 12 month follow up Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, user or other persons. A clinical occurrence means that it affects or might affect a patient's normal function.	2.1% 3/142 • Adverse Event data was collected from time of randomization through 12 month follow up Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, user or other persons. A clinical occurrence means that it affects or might affect a patient's normal function.
Injury, poisoning and procedural complications Haematoma	0.00% 0/142 • Adverse Event data was collected from time of randomization through 12 month follow up Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, user or other persons. A clinical occurrence means that it affects or might affect a patient's normal function.	1.4% 2/142 • Adverse Event data was collected from time of randomization through 12 month follow up Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, user or other persons. A clinical occurrence means that it affects or might affect a patient's normal function.
Gastrointestinal disorders Inguinal Hernia	0.70% 1/142 • Adverse Event data was collected from time of randomization through 12 month follow up Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, user or other persons. A clinical occurrence means that it affects or might affect a patient's normal function.	1.4% 2/142 • Adverse Event data was collected from time of randomization through 12 month follow up Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, user or other persons. A clinical occurrence means that it affects or might affect a patient's normal function.
Nervous system disorders Neuralgia	1.4% 2/142 • Adverse Event data was collected from time of randomization through 12 month follow up Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, user or other persons. A clinical occurrence means that it affects or might affect a patient's normal function.	0.00% 0/142 • Adverse Event data was collected from time of randomization through 12 month follow up Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, user or other persons. A clinical occurrence means that it affects or might affect a patient's normal function.
Vascular disorders Cerebro Vascular Accident	0.00% 0/142 • Adverse Event data was collected from time of randomization through 12 month follow up Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, user or other persons. A clinical occurrence means that it affects or might affect a patient's normal function.	0.70% 1/142 • Adverse Event data was collected from time of randomization through 12 month follow up Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, user or other persons. A clinical occurrence means that it affects or might affect a patient's normal function.
Musculoskeletal and connective tissue disorders Cervical vertebral fracture	0.70% 1/142 • Adverse Event data was collected from time of randomization through 12 month follow up Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, user or other persons. A clinical occurrence means that it affects or might affect a patient's normal function.	0.00% 0/142 • Adverse Event data was collected from time of randomization through 12 month follow up Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, user or other persons. A clinical occurrence means that it affects or might affect a patient's normal function.
General disorders Dizziness	0.00% 0/142 • Adverse Event data was collected from time of randomization through 12 month follow up Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, user or other persons. A clinical occurrence means that it affects or might affect a patient's normal function.	0.70% 1/142 • Adverse Event data was collected from time of randomization through 12 month follow up Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, user or other persons. A clinical occurrence means that it affects or might affect a patient's normal function.
Gastrointestinal disorders Haemorrhoids thrombosed	0.00% 0/142 • Adverse Event data was collected from time of randomization through 12 month follow up Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, user or other persons. A clinical occurrence means that it affects or might affect a patient's normal function.	0.70% 1/142 • Adverse Event data was collected from time of randomization through 12 month follow up Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, user or other persons. A clinical occurrence means that it affects or might affect a patient's normal function.
General disorders Incisional Hernia	0.70% 1/142 • Adverse Event data was collected from time of randomization through 12 month follow up Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, user or other persons. A clinical occurrence means that it affects or might affect a patient's normal function.	0.00% 0/142 • Adverse Event data was collected from time of randomization through 12 month follow up Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, user or other persons. A clinical occurrence means that it affects or might affect a patient's normal function.
Gastrointestinal disorders Intestinal obstruction	0.70% 1/142 • Adverse Event data was collected from time of randomization through 12 month follow up Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, user or other persons. A clinical occurrence means that it affects or might affect a patient's normal function.	0.00% 0/142 • Adverse Event data was collected from time of randomization through 12 month follow up Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, user or other persons. A clinical occurrence means that it affects or might affect a patient's normal function.
Musculoskeletal and connective tissue disorders Leiomyosarcoma	0.00% 0/142 • Adverse Event data was collected from time of randomization through 12 month follow up Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, user or other persons. A clinical occurrence means that it affects or might affect a patient's normal function.	0.70% 1/142 • Adverse Event data was collected from time of randomization through 12 month follow up Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, user or other persons. A clinical occurrence means that it affects or might affect a patient's normal function.
Injury, poisoning and procedural complications Medical device site infection	0.70% 1/142 • Adverse Event data was collected from time of randomization through 12 month follow up Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, user or other persons. A clinical occurrence means that it affects or might affect a patient's normal function.	0.00% 0/142 • Adverse Event data was collected from time of randomization through 12 month follow up Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, user or other persons. A clinical occurrence means that it affects or might affect a patient's normal function.
Injury, poisoning and procedural complications Procedural pain	0.70% 1/142 • Adverse Event data was collected from time of randomization through 12 month follow up Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, user or other persons. A clinical occurrence means that it affects or might affect a patient's normal function.	0.00% 0/142 • Adverse Event data was collected from time of randomization through 12 month follow up Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, user or other persons. A clinical occurrence means that it affects or might affect a patient's normal function.
Reproductive system and breast disorders Prostate cancer metastatic	0.70% 1/142 • Adverse Event data was collected from time of randomization through 12 month follow up Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, user or other persons. A clinical occurrence means that it affects or might affect a patient's normal function.	0.00% 0/142 • Adverse Event data was collected from time of randomization through 12 month follow up Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, user or other persons. A clinical occurrence means that it affects or might affect a patient's normal function.
Infections and infestations Tooth Abcess	0.00% 0/142 • Adverse Event data was collected from time of randomization through 12 month follow up Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, user or other persons. A clinical occurrence means that it affects or might affect a patient's normal function.	0.70% 1/142 • Adverse Event data was collected from time of randomization through 12 month follow up Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, user or other persons. A clinical occurrence means that it affects or might affect a patient's normal function.
Renal and urinary disorders Urethral injury	0.00% 0/142 • Adverse Event data was collected from time of randomization through 12 month follow up Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, user or other persons. A clinical occurrence means that it affects or might affect a patient's normal function.	0.70% 1/142 • Adverse Event data was collected from time of randomization through 12 month follow up Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, user or other persons. A clinical occurrence means that it affects or might affect a patient's normal function.
Renal and urinary disorders Urinary retention	0.70% 1/142 • Adverse Event data was collected from time of randomization through 12 month follow up Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, user or other persons. A clinical occurrence means that it affects or might affect a patient's normal function.	0.00% 0/142 • Adverse Event data was collected from time of randomization through 12 month follow up Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, user or other persons. A clinical occurrence means that it affects or might affect a patient's normal function.
Injury, poisoning and procedural complications Urinary tract injury	0.00% 0/142 • Adverse Event data was collected from time of randomization through 12 month follow up Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, user or other persons. A clinical occurrence means that it affects or might affect a patient's normal function.	0.70% 1/142 • Adverse Event data was collected from time of randomization through 12 month follow up Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, user or other persons. A clinical occurrence means that it affects or might affect a patient's normal function.
Renal and urinary disorders Urosepsis	0.00% 0/142 • Adverse Event data was collected from time of randomization through 12 month follow up Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, user or other persons. A clinical occurrence means that it affects or might affect a patient's normal function.	0.70% 1/142 • Adverse Event data was collected from time of randomization through 12 month follow up Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, user or other persons. A clinical occurrence means that it affects or might affect a patient's normal function.
Injury, poisoning and procedural complications Vomiting	0.00% 0/142 • Adverse Event data was collected from time of randomization through 12 month follow up Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, user or other persons. A clinical occurrence means that it affects or might affect a patient's normal function.	0.70% 1/142 • Adverse Event data was collected from time of randomization through 12 month follow up Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, user or other persons. A clinical occurrence means that it affects or might affect a patient's normal function.