Trial Outcomes & Findings for Artificial Urinary Sphincter Clinical Outcomes (NCT NCT04088331)

NCT ID: NCT04088331

Last Updated: 2026-01-14

Results Overview

Number of subjects achieving 50% reduction or greater in baseline urinary incontinence as measured by 24-hour pad weight test at 12 months post device activation

• Recruitment status: COMPLETED
• Target enrollment: 145 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2026-01-14

Participant Flow

Subjects will be considered enrolled in the study once they sign the informed consent. All enrolled subjects will have been consented prior to the procedure. All enrolled subjects with a surgery initiated (i.e. first incision) will be considered part of the Intent-to-Treat (ITT) population. A total of 145 subjects were enrolled and 115 continued on to undergo the index procedure, qualifying them for inclusion in the ITT population.

Participant milestones

Measure	AMS 800 Artificial Urinary Sphincter Recipients Adult males with moderate to severe primary stress urinary incontinence (as assessed by a baseline pad weight test) due to ISD who meet the indications for surgical correction of urinary incontinence.
Overall Study STARTED	115
Overall Study COMPLETED	101
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Measure	AMS 800 Artificial Urinary Sphincter Recipients Adult males with moderate to severe primary stress urinary incontinence (as assessed by a baseline pad weight test) due to ISD who meet the indications for surgical correction of urinary incontinence.
Overall Study Lost to Follow-up	3
Overall Study Withdrawal by Subject	7
Overall Study Adverse Event	4

Baseline Characteristics

Artificial Urinary Sphincter Clinical Outcomes

Baseline characteristics by cohort

Measure	AMS 800 Artificial Urinary Sphincter Recipients n=115 Participants Adult males with moderate to severe primary stress urinary incontinence (as assessed by a baseline pad weight test) due to ISD who meet the indications for surgical correction of urinary incontinence.
Age, Categorical <=18 years	0 Participants n=14 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=14 Participants
Age, Categorical >=65 years	98 Participants n=14 Participants
Sex: Female, Male Female	0 Participants n=14 Participants
Sex: Female, Male Male	115 Participants n=14 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=14 Participants
Race (NIH/OMB) Asian	0 Participants n=14 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=14 Participants
Race (NIH/OMB) Black or African American	14 Participants n=14 Participants
Race (NIH/OMB) White	100 Participants n=14 Participants
Race (NIH/OMB) More than one race	0 Participants n=14 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=14 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=14 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	109 Participants n=14 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=14 Participants

PRIMARY outcome

Timeframe: 12 months

Population: The analysis was performed on subjects in the Intent to Treat (ITT) population who had available 24-hr pad weight data available at their 12 month follow-up visit. The ITT subject population included all subjects who provided written informed consent to be enrolled into the study, and have a surgery initiated (defined as the first incision).

Number of subjects achieving 50% reduction or greater in baseline urinary incontinence as measured by 24-hour pad weight test at 12 months post device activation

Outcome measures

Measure	AMS 800 Artificial Urinary Sphincter Recipients n=97 Participants Adult males with moderate to severe primary stress urinary incontinence (as assessed by a baseline pad weight test) due to ISD who meet the indications for surgical correction of urinary incontinence.
Number of Subjects With Reduction in 24 Hour Pad Weight Test at 12 Months	91 Participants

SECONDARY outcome

Timeframe: 3 months, 6 months, and 12 months

Population: The analysis was performed for the Intent to Treat (ITT) population. The ITT subject population included all subjects who provided written informed consent to be enrolled into the study, and have a surgery initiated (defined as the first incision).

Percentage of Participants that Required Revision (Revision Rates), had Serious Adverse Events, and had Serious Adverse Events that are Device and/or Procedure Related at 3 months, 6 months, and 12 months. Adverse event and revision rates are summarized by the Kaplan-Meier estimate with revision/event timing relative to the index procedure.

Outcome measures

Measure	AMS 800 Artificial Urinary Sphincter Recipients n=115 Participants Adult males with moderate to severe primary stress urinary incontinence (as assessed by a baseline pad weight test) due to ISD who meet the indications for surgical correction of urinary incontinence.
Percentage of Participants That Required Revision (Revision Rates), Had Serious Adverse Events, and Had Serious Adverse Events That Are Device and/or Procedure Related Incidence of Safety Parameters at 3 months: Revision Rates	3.5 Percentage of participants Interval 1.3 to 9.1
Percentage of Participants That Required Revision (Revision Rates), Had Serious Adverse Events, and Had Serious Adverse Events That Are Device and/or Procedure Related Incidence of Safety Parameters at 3 months: Serious adverse events	9.6 Percentage of participants Interval 5.5 to 16.7
Percentage of Participants That Required Revision (Revision Rates), Had Serious Adverse Events, and Had Serious Adverse Events That Are Device and/or Procedure Related Incidence of Safety Parameters at 3 months: SAEs that are device and/or procedure related	5.2 Percentage of participants Interval 2.4 to 11.3
Percentage of Participants That Required Revision (Revision Rates), Had Serious Adverse Events, and Had Serious Adverse Events That Are Device and/or Procedure Related ncidence of Safety Parameters at 6 months: Revision Rates	6.2 Percentage of participants Interval 3.0 to 12.6
Percentage of Participants That Required Revision (Revision Rates), Had Serious Adverse Events, and Had Serious Adverse Events That Are Device and/or Procedure Related Incidence of Safety Parameters at 6 months: Serious adverse events	12.4 Percentage of participants Interval 7.5 to 20.0
Percentage of Participants That Required Revision (Revision Rates), Had Serious Adverse Events, and Had Serious Adverse Events That Are Device and/or Procedure Related Incidence of Safety Parameters at 6 months: SAEs that are device and/or procedure related	7.0 Percentage of participants Interval 3.6 to 13.6
Percentage of Participants That Required Revision (Revision Rates), Had Serious Adverse Events, and Had Serious Adverse Events That Are Device and/or Procedure Related Incidence of Safety Parameters at 12 months: Revision Rates	7.2 Percentage of participants Interval 3.7 to 13.8
Percentage of Participants That Required Revision (Revision Rates), Had Serious Adverse Events, and Had Serious Adverse Events That Are Device and/or Procedure Related Incidence of Safety Parameters at 12 months: Serious adverse events	15.2 Percentage of participants Interval 9.7 to 23.3
Percentage of Participants That Required Revision (Revision Rates), Had Serious Adverse Events, and Had Serious Adverse Events That Are Device and/or Procedure Related Incidence of Safety Parameters at 12 months: SAEs that are device and/or procedure related	8.9 Percentage of participants Interval 4.9 to 16.0

SECONDARY outcome

Timeframe: Device Activation

Population: 107 subjects had data at both baseline and device activation.

Number of subjects achieving ≥ 50% reduction in urinary incontinence as measured by 24-hour pad weight test at device activation compared to baseline

Outcome measures

Measure	AMS 800 Artificial Urinary Sphincter Recipients n=107 Participants Adult males with moderate to severe primary stress urinary incontinence (as assessed by a baseline pad weight test) due to ISD who meet the indications for surgical correction of urinary incontinence.
Number of Subjects Achieving ≥ 50% Reduction in 24 Hour Pad Weight Test at Device Activation	75 Participants

SECONDARY outcome

Timeframe: Device Activation

≥ 75% reduction in urinary incontinence as measured by 24-hour pad weight test at device activation compared to baseline

Outcome measures

Measure	AMS 800 Artificial Urinary Sphincter Recipients n=107 Participants Adult males with moderate to severe primary stress urinary incontinence (as assessed by a baseline pad weight test) due to ISD who meet the indications for surgical correction of urinary incontinence.
Number of Subjects Achieving ≥ 75% Reduction in 24 Hour Pad Weight Test at Device Activation	70 Participants

SECONDARY outcome

Timeframe: 3 months

Population: 109 subjects had data at both baseline and 3 months post device activation.

Change in number of pads per day at 3 months compared to baseline. Change was calculated by subtracting the number of pads per day at baseline from the number of pads per day at 3 months.

Outcome measures

Measure	AMS 800 Artificial Urinary Sphincter Recipients n=109 Participants Adult males with moderate to severe primary stress urinary incontinence (as assessed by a baseline pad weight test) due to ISD who meet the indications for surgical correction of urinary incontinence.
Change in Number of Pads Per Day at 3 Months	-4.0 Pads per day Interval -4.4 to -3.5

SECONDARY outcome

Timeframe: 6 months

Population: 99 subjects had data at both baseline and 6 months post device activation.

Number of subjects achieving ≥ 50% reduction in urinary incontinence as measured by 24-hour pad weight test at 6 months post device activation compared to baseline

Outcome measures

Measure	AMS 800 Artificial Urinary Sphincter Recipients n=99 Participants Adult males with moderate to severe primary stress urinary incontinence (as assessed by a baseline pad weight test) due to ISD who meet the indications for surgical correction of urinary incontinence.
Number of Subjects Achieving ≥ 50% Reduction in 24 Hour Pad Weight Test at 6 Months	88 Participants

SECONDARY outcome

Timeframe: 6 months

Population: 99 subjects had data at both baseline and 6 months post device activation.

≥ 75% reduction in urinary incontinence as measured by 24-hour pad weight test at 6 months post device activation compared to baseline

Outcome measures

Measure	AMS 800 Artificial Urinary Sphincter Recipients n=99 Participants Adult males with moderate to severe primary stress urinary incontinence (as assessed by a baseline pad weight test) due to ISD who meet the indications for surgical correction of urinary incontinence.
Number of Subjects Achieving ≥ 75% Reduction in 24 Hour Pad Weight Test at 6 Months	84 Participants

SECONDARY outcome

Timeframe: 12 months

Population: 97 subjects had data at both baseline and 6 months post device activation.

≥ 75% reduction in urinary incontinence as measured by 24-hour pad weight test at 12 months post device activation compared to baseline

Outcome measures

Measure	AMS 800 Artificial Urinary Sphincter Recipients n=97 Participants Adult males with moderate to severe primary stress urinary incontinence (as assessed by a baseline pad weight test) due to ISD who meet the indications for surgical correction of urinary incontinence.
Number of Subjects Achieving ≥ 75% Reduction in 24 Hour Pad Weight Test at 12 Months	83 Participants

SECONDARY outcome

Timeframe: 6 months

Population: 99 subjects had data at both baseline and 6 months post device activation.

Change in number of pads per day at 6 months post-device activation compared to baseline. Change was calculated by subtracting the number of pads per day at baseline from the number of pads per day at 6 months.

Outcome measures

Measure	AMS 800 Artificial Urinary Sphincter Recipients n=99 Participants Adult males with moderate to severe primary stress urinary incontinence (as assessed by a baseline pad weight test) due to ISD who meet the indications for surgical correction of urinary incontinence.
Change in Number of Pads Per Day at 6 Months	-4.0 Pads per day Interval -4.5 to -3.5

SECONDARY outcome

Timeframe: 12 months

Population: 101 subjects had data at both baseline and 12 months post device activation.

Change in number of pads per day at 12 months post-device activation compared to baseline. Change was calculated by subtracting the number of pads per day at baseline from the number of pads per day at 12 months.

Outcome measures

Measure	AMS 800 Artificial Urinary Sphincter Recipients n=101 Participants Adult males with moderate to severe primary stress urinary incontinence (as assessed by a baseline pad weight test) due to ISD who meet the indications for surgical correction of urinary incontinence.
Change in Number of Pads Per Day at 12 Months	-3.9 Pads per day Interval -4.4 to -3.4

Adverse Events

AMS 800 Artificial Urinary Sphincter Recipients

Serious events: 17 serious events

Other events: 27 other events

Deaths: 3 deaths

Serious adverse events

Measure	AMS 800 Artificial Urinary Sphincter Recipients n=115 participants at risk Adult males with moderate to severe primary stress urinary incontinence (as assessed by a baseline pad weight test) due to ISD who meet the indications for surgical correction of urinary incontinence.
Cardiac disorders Acute myocardial infarction	0.87% 1/115 • Number of events 1 • Adverse events were collected from the time of index procedure through study completion, which was up to 12 months post-device activation. AE reporting included: Serious Adverse Events, Serious Adverse Device Effects, Adverse Device Effects, and Procedure Related Adverse Events
Cardiac disorders Coronary artery disease	0.87% 1/115 • Number of events 1 • Adverse events were collected from the time of index procedure through study completion, which was up to 12 months post-device activation. AE reporting included: Serious Adverse Events, Serious Adverse Device Effects, Adverse Device Effects, and Procedure Related Adverse Events
General disorders Death	0.87% 1/115 • Number of events 1 • Adverse events were collected from the time of index procedure through study completion, which was up to 12 months post-device activation. AE reporting included: Serious Adverse Events, Serious Adverse Device Effects, Adverse Device Effects, and Procedure Related Adverse Events
General disorders Medical device site erosion	0.87% 1/115 • Number of events 1 • Adverse events were collected from the time of index procedure through study completion, which was up to 12 months post-device activation. AE reporting included: Serious Adverse Events, Serious Adverse Device Effects, Adverse Device Effects, and Procedure Related Adverse Events
General disorders Medical device site induration	0.87% 1/115 • Number of events 1 • Adverse events were collected from the time of index procedure through study completion, which was up to 12 months post-device activation. AE reporting included: Serious Adverse Events, Serious Adverse Device Effects, Adverse Device Effects, and Procedure Related Adverse Events
Infections and infestations Bacteraemia	0.87% 1/115 • Number of events 1 • Adverse events were collected from the time of index procedure through study completion, which was up to 12 months post-device activation. AE reporting included: Serious Adverse Events, Serious Adverse Device Effects, Adverse Device Effects, and Procedure Related Adverse Events
Infections and infestations Infected skin ulcer	0.87% 1/115 • Number of events 1 • Adverse events were collected from the time of index procedure through study completion, which was up to 12 months post-device activation. AE reporting included: Serious Adverse Events, Serious Adverse Device Effects, Adverse Device Effects, and Procedure Related Adverse Events
Infections and infestations Labyrinthitis	0.87% 1/115 • Number of events 1 • Adverse events were collected from the time of index procedure through study completion, which was up to 12 months post-device activation. AE reporting included: Serious Adverse Events, Serious Adverse Device Effects, Adverse Device Effects, and Procedure Related Adverse Events
Infections and infestations Pneumonia	0.87% 1/115 • Number of events 1 • Adverse events were collected from the time of index procedure through study completion, which was up to 12 months post-device activation. AE reporting included: Serious Adverse Events, Serious Adverse Device Effects, Adverse Device Effects, and Procedure Related Adverse Events
Infections and infestations Sepsis	1.7% 2/115 • Number of events 2 • Adverse events were collected from the time of index procedure through study completion, which was up to 12 months post-device activation. AE reporting included: Serious Adverse Events, Serious Adverse Device Effects, Adverse Device Effects, and Procedure Related Adverse Events
Infections and infestations Urinary tract infection	1.7% 2/115 • Number of events 2 • Adverse events were collected from the time of index procedure through study completion, which was up to 12 months post-device activation. AE reporting included: Serious Adverse Events, Serious Adverse Device Effects, Adverse Device Effects, and Procedure Related Adverse Events
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal adenocarcinoma	0.87% 1/115 • Number of events 1 • Adverse events were collected from the time of index procedure through study completion, which was up to 12 months post-device activation. AE reporting included: Serious Adverse Events, Serious Adverse Device Effects, Adverse Device Effects, and Procedure Related Adverse Events
Nervous system disorders Cerebrovascular accident	0.87% 1/115 • Number of events 1 • Adverse events were collected from the time of index procedure through study completion, which was up to 12 months post-device activation. AE reporting included: Serious Adverse Events, Serious Adverse Device Effects, Adverse Device Effects, and Procedure Related Adverse Events
Nervous system disorders Transient ischaemic attack	0.87% 1/115 • Number of events 1 • Adverse events were collected from the time of index procedure through study completion, which was up to 12 months post-device activation. AE reporting included: Serious Adverse Events, Serious Adverse Device Effects, Adverse Device Effects, and Procedure Related Adverse Events
Product Issues Device dislocation	0.87% 1/115 • Number of events 1 • Adverse events were collected from the time of index procedure through study completion, which was up to 12 months post-device activation. AE reporting included: Serious Adverse Events, Serious Adverse Device Effects, Adverse Device Effects, and Procedure Related Adverse Events
Renal and urinary disorders Haematuria	0.87% 1/115 • Number of events 1 • Adverse events were collected from the time of index procedure through study completion, which was up to 12 months post-device activation. AE reporting included: Serious Adverse Events, Serious Adverse Device Effects, Adverse Device Effects, and Procedure Related Adverse Events
Renal and urinary disorders Incontinence	0.87% 1/115 • Number of events 1 • Adverse events were collected from the time of index procedure through study completion, which was up to 12 months post-device activation. AE reporting included: Serious Adverse Events, Serious Adverse Device Effects, Adverse Device Effects, and Procedure Related Adverse Events
Renal and urinary disorders Renal mass	0.87% 1/115 • Number of events 1 • Adverse events were collected from the time of index procedure through study completion, which was up to 12 months post-device activation. AE reporting included: Serious Adverse Events, Serious Adverse Device Effects, Adverse Device Effects, and Procedure Related Adverse Events
Renal and urinary disorders Urinary fistula	0.87% 1/115 • Number of events 1 • Adverse events were collected from the time of index procedure through study completion, which was up to 12 months post-device activation. AE reporting included: Serious Adverse Events, Serious Adverse Device Effects, Adverse Device Effects, and Procedure Related Adverse Events
Renal and urinary disorders Urinary incontinence	0.87% 1/115 • Number of events 1 • Adverse events were collected from the time of index procedure through study completion, which was up to 12 months post-device activation. AE reporting included: Serious Adverse Events, Serious Adverse Device Effects, Adverse Device Effects, and Procedure Related Adverse Events
Renal and urinary disorders Urinary retention	0.87% 1/115 • Number of events 1 • Adverse events were collected from the time of index procedure through study completion, which was up to 12 months post-device activation. AE reporting included: Serious Adverse Events, Serious Adverse Device Effects, Adverse Device Effects, and Procedure Related Adverse Events
Renal and urinary disorders Urothelium erosion	0.87% 1/115 • Number of events 1 • Adverse events were collected from the time of index procedure through study completion, which was up to 12 months post-device activation. AE reporting included: Serious Adverse Events, Serious Adverse Device Effects, Adverse Device Effects, and Procedure Related Adverse Events
Surgical and medical procedures Medical device change	1.7% 2/115 • Number of events 2 • Adverse events were collected from the time of index procedure through study completion, which was up to 12 months post-device activation. AE reporting included: Serious Adverse Events, Serious Adverse Device Effects, Adverse Device Effects, and Procedure Related Adverse Events

Other adverse events

Measure	AMS 800 Artificial Urinary Sphincter Recipients n=115 participants at risk Adult males with moderate to severe primary stress urinary incontinence (as assessed by a baseline pad weight test) due to ISD who meet the indications for surgical correction of urinary incontinence.
General disorders Localized oedema	0.87% 1/115 • Number of events 1 • Adverse events were collected from the time of index procedure through study completion, which was up to 12 months post-device activation. AE reporting included: Serious Adverse Events, Serious Adverse Device Effects, Adverse Device Effects, and Procedure Related Adverse Events
General disorders Medical device site discomfort	1.7% 2/115 • Number of events 2 • Adverse events were collected from the time of index procedure through study completion, which was up to 12 months post-device activation. AE reporting included: Serious Adverse Events, Serious Adverse Device Effects, Adverse Device Effects, and Procedure Related Adverse Events
General disorders Medical device site haematoma	0.87% 1/115 • Number of events 1 • Adverse events were collected from the time of index procedure through study completion, which was up to 12 months post-device activation. AE reporting included: Serious Adverse Events, Serious Adverse Device Effects, Adverse Device Effects, and Procedure Related Adverse Events
General disorders Medical device site reaction	0.87% 1/115 • Number of events 1 • Adverse events were collected from the time of index procedure through study completion, which was up to 12 months post-device activation. AE reporting included: Serious Adverse Events, Serious Adverse Device Effects, Adverse Device Effects, and Procedure Related Adverse Events
Infections and infestations Postoperative wound infection	2.6% 3/115 • Number of events 3 • Adverse events were collected from the time of index procedure through study completion, which was up to 12 months post-device activation. AE reporting included: Serious Adverse Events, Serious Adverse Device Effects, Adverse Device Effects, and Procedure Related Adverse Events
Infections and infestations Scrotal infection	0.87% 1/115 • Number of events 1 • Adverse events were collected from the time of index procedure through study completion, which was up to 12 months post-device activation. AE reporting included: Serious Adverse Events, Serious Adverse Device Effects, Adverse Device Effects, and Procedure Related Adverse Events
Infections and infestations Urinary tract infection	1.7% 2/115 • Number of events 2 • Adverse events were collected from the time of index procedure through study completion, which was up to 12 months post-device activation. AE reporting included: Serious Adverse Events, Serious Adverse Device Effects, Adverse Device Effects, and Procedure Related Adverse Events
Injury, poisoning and procedural complications Incision site pain	0.87% 1/115 • Number of events 1 • Adverse events were collected from the time of index procedure through study completion, which was up to 12 months post-device activation. AE reporting included: Serious Adverse Events, Serious Adverse Device Effects, Adverse Device Effects, and Procedure Related Adverse Events
Injury, poisoning and procedural complications Incision site swelling	0.87% 1/115 • Number of events 1 • Adverse events were collected from the time of index procedure through study completion, which was up to 12 months post-device activation. AE reporting included: Serious Adverse Events, Serious Adverse Device Effects, Adverse Device Effects, and Procedure Related Adverse Events
Injury, poisoning and procedural complications Scrotal haematoma	0.87% 1/115 • Number of events 1 • Adverse events were collected from the time of index procedure through study completion, which was up to 12 months post-device activation. AE reporting included: Serious Adverse Events, Serious Adverse Device Effects, Adverse Device Effects, and Procedure Related Adverse Events
Injury, poisoning and procedural complications Wound dehiscence	1.7% 2/115 • Number of events 2 • Adverse events were collected from the time of index procedure through study completion, which was up to 12 months post-device activation. AE reporting included: Serious Adverse Events, Serious Adverse Device Effects, Adverse Device Effects, and Procedure Related Adverse Events
Nervous system disorders Pudendal canal syndrome	0.87% 1/115 • Number of events 1 • Adverse events were collected from the time of index procedure through study completion, which was up to 12 months post-device activation. AE reporting included: Serious Adverse Events, Serious Adverse Device Effects, Adverse Device Effects, and Procedure Related Adverse Events
Renal and urinary disorders Dysuria	1.7% 2/115 • Number of events 2 • Adverse events were collected from the time of index procedure through study completion, which was up to 12 months post-device activation. AE reporting included: Serious Adverse Events, Serious Adverse Device Effects, Adverse Device Effects, and Procedure Related Adverse Events
Renal and urinary disorders Haematuria	0.87% 1/115 • Number of events 1 • Adverse events were collected from the time of index procedure through study completion, which was up to 12 months post-device activation. AE reporting included: Serious Adverse Events, Serious Adverse Device Effects, Adverse Device Effects, and Procedure Related Adverse Events
Renal and urinary disorders Micturition urgency	0.87% 1/115 • Number of events 1 • Adverse events were collected from the time of index procedure through study completion, which was up to 12 months post-device activation. AE reporting included: Serious Adverse Events, Serious Adverse Device Effects, Adverse Device Effects, and Procedure Related Adverse Events
Renal and urinary disorders Urethritis noninfective	0.87% 1/115 • Number of events 1 • Adverse events were collected from the time of index procedure through study completion, which was up to 12 months post-device activation. AE reporting included: Serious Adverse Events, Serious Adverse Device Effects, Adverse Device Effects, and Procedure Related Adverse Events
Renal and urinary disorders Urinary retention	2.6% 3/115 • Number of events 3 • Adverse events were collected from the time of index procedure through study completion, which was up to 12 months post-device activation. AE reporting included: Serious Adverse Events, Serious Adverse Device Effects, Adverse Device Effects, and Procedure Related Adverse Events
Reproductive system and breast disorders Oedema genital	0.87% 1/115 • Number of events 1 • Adverse events were collected from the time of index procedure through study completion, which was up to 12 months post-device activation. AE reporting included: Serious Adverse Events, Serious Adverse Device Effects, Adverse Device Effects, and Procedure Related Adverse Events
Reproductive system and breast disorders Perineal pain	0.87% 1/115 • Number of events 1 • Adverse events were collected from the time of index procedure through study completion, which was up to 12 months post-device activation. AE reporting included: Serious Adverse Events, Serious Adverse Device Effects, Adverse Device Effects, and Procedure Related Adverse Events
Reproductive system and breast disorders Scrotal erythema	0.87% 1/115 • Number of events 1 • Adverse events were collected from the time of index procedure through study completion, which was up to 12 months post-device activation. AE reporting included: Serious Adverse Events, Serious Adverse Device Effects, Adverse Device Effects, and Procedure Related Adverse Events
Reproductive system and breast disorders Scrotal swelling	2.6% 3/115 • Number of events 3 • Adverse events were collected from the time of index procedure through study completion, which was up to 12 months post-device activation. AE reporting included: Serious Adverse Events, Serious Adverse Device Effects, Adverse Device Effects, and Procedure Related Adverse Events
Reproductive system and breast disorders Testicular pain	3.5% 4/115 • Number of events 4 • Adverse events were collected from the time of index procedure through study completion, which was up to 12 months post-device activation. AE reporting included: Serious Adverse Events, Serious Adverse Device Effects, Adverse Device Effects, and Procedure Related Adverse Events

Additional Information

Winnie Chen

Boston Scientific

Phone: 952-930-6000

Email: Winnie.Chen@bsci.com

Results disclosure agreements

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

Restriction type: LTE60