Trial Outcomes & Findings for A Pre-Market Study of the American Medical Systems (AMS) Transobturator Male Sling System for the Treatment of Male Stress Urinary Incontinence (NCT NCT00904969)

NCT ID: NCT00904969

Last Updated: 2018-01-30

Results Overview

Characterize procedure time from first incision to closing.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 55 participants
• Primary outcome timeframe: During Procedure, Approximately 60 Minutes
• Results posted on: 2018-01-30

Participant Flow

10 clinical Sites enrolled and implanted subjects. All subjects gave informed consent prior to enrollment and all implanted subjects met the inclusion / exclusion criteria. Enrollment into the study began in February 2006 and ended April 2007.

Subjects who meet the inclusion / exclusion criteria and were good surgical candidates were enrolled into the single arm study and were eligible to be implanted.

Participant milestones

Measure	Treated Participants Participants in which a device placement was attempted.
Overall Study STARTED	50
Overall Study COMPLETED	31
Overall Study NOT COMPLETED	19

Reasons for withdrawal

Measure	Treated Participants Participants in which a device placement was attempted.
Overall Study Lost to Follow-up	4
Overall Study Withdrawal by Subject	3
Overall Study Additional Treatments	11
Overall Study Case Aborted; Subject Exited	1

Baseline Characteristics

A Pre-Market Study of the American Medical Systems (AMS) Transobturator Male Sling System for the Treatment of Male Stress Urinary Incontinence

Baseline characteristics by cohort

Measure	Treated Participants n=50 Participants Participants in which a device placement was attempted.
Age, Continuous	64.6 years STANDARD_DEVIATION 8.7 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	50 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	39 participants n=5 Participants
Race/Ethnicity, Customized African American	10 participants n=5 Participants
Race/Ethnicity, Customized Asian	1 participants n=5 Participants
Region of Enrollment United States	48 participants n=5 Participants
Region of Enrollment Canada	2 participants n=5 Participants
Primary etiology of intrinsic sphincter deficiency (ISD) Post-Transurethral Resection of Prostate (TURP)	3 participants n=5 Participants
Primary etiology of intrinsic sphincter deficiency (ISD) Radical Prostatectomy	47 participants n=5 Participants
Years Since Surgery <=1995	7 participants n=5 Participants
Years Since Surgery 1996 - 2001	14 participants n=5 Participants
Years Since Surgery 2002-2004	18 participants n=5 Participants
Years Since Surgery 2005	8 participants n=5 Participants
Years Since Surgery 2006	3 participants n=5 Participants
Duration of Incontinence Symptoms	57.2 months STANDARD_DEVIATION 76.5 • n=5 Participants

PRIMARY outcome

Timeframe: During Procedure, Approximately 60 Minutes

Characterize procedure time from first incision to closing.

Outcome measures

Measure	Treated Participants n=50 Participants Participants in which a device placement was attempted.	6 Month 6 Month Follow-Up Visit	12 Month 12 Month Follow-Up Visit	24 Month 24 Month Follow-Up Visit	24 Month LOCF 24 Month Visit using Last Observation Carried Forward	24 Month WCS 24 Month Visit using Worse Case Scenario
Procedural Endpoint: Procedure Time From First Incision to Closing.	61.8 minutes Standard Deviation 25.4	—	—	—	—	—

PRIMARY outcome

Timeframe: During Procedure, Approximately 60 Minutes

Describe the type of anesthesia used.

Outcome measures

Measure	Treated Participants n=50 Participants Participants in which a device placement was attempted.	6 Month 6 Month Follow-Up Visit	12 Month 12 Month Follow-Up Visit	24 Month 24 Month Follow-Up Visit	24 Month LOCF 24 Month Visit using Last Observation Carried Forward	24 Month WCS 24 Month Visit using Worse Case Scenario
Procedural Endpoint: Type of Anesthesia Used General	41 Participants	—	—	—	—	—
Procedural Endpoint: Type of Anesthesia Used Spinal	9 Participants	—	—	—	—	—

PRIMARY outcome

Timeframe: During Procedure, Approximately 60 Minutes

Number of participants requiring the use of a foley catheter intra-operatively.

Outcome measures

Measure	Treated Participants n=50 Participants Participants in which a device placement was attempted.	6 Month 6 Month Follow-Up Visit	12 Month 12 Month Follow-Up Visit	24 Month 24 Month Follow-Up Visit	24 Month LOCF 24 Month Visit using Last Observation Carried Forward	24 Month WCS 24 Month Visit using Worse Case Scenario
Procedural Endpoint: Rate of Foley Catheter Use - Intraoperative	44 Participants	—	—	—	—	—

PRIMARY outcome

Timeframe: post-operative to discharge

Number of participants requiring the use of a foley catheter who were able to void prior to discharge.

Outcome measures

Measure	Treated Participants n=50 Participants Participants in which a device placement was attempted.	6 Month 6 Month Follow-Up Visit	12 Month 12 Month Follow-Up Visit	24 Month 24 Month Follow-Up Visit	24 Month LOCF 24 Month Visit using Last Observation Carried Forward	24 Month WCS 24 Month Visit using Worse Case Scenario
Procedural Endpoint: Rate of Foley Catheter Use - Post-operative	39 Participants	—	—	—	—	—

PRIMARY outcome

Timeframe: post discharge

Number of participants requiring the use of a foley catheter post-discharge following Bladder Management instructions.

Outcome measures

Measure	Treated Participants n=50 Participants Participants in which a device placement was attempted.	6 Month 6 Month Follow-Up Visit	12 Month 12 Month Follow-Up Visit	24 Month 24 Month Follow-Up Visit	24 Month LOCF 24 Month Visit using Last Observation Carried Forward	24 Month WCS 24 Month Visit using Worse Case Scenario
Procedural Endpoint: Rate of Foley Catheter Use - Post-discharge No instructions	35 Participants	—	—	—	—	—
Procedural Endpoint: Rate of Foley Catheter Use - Post-discharge Intermittent self-catheterization	5 Participants	—	—	—	—	—
Procedural Endpoint: Rate of Foley Catheter Use - Post-discharge Foley catheter	10 Participants	—	—	—	—	—

PRIMARY outcome

Timeframe: During Procedure, Approximately 60 Minutes

Characterize procedural parameters including the use of tack sutures.

Outcome measures

Measure	Treated Participants n=50 Participants Participants in which a device placement was attempted.	6 Month 6 Month Follow-Up Visit	12 Month 12 Month Follow-Up Visit	24 Month 24 Month Follow-Up Visit	24 Month LOCF 24 Month Visit using Last Observation Carried Forward	24 Month WCS 24 Month Visit using Worse Case Scenario
Procedural Endpoint: Descriptive Procedural Parameters - Use of Tack Sutures Tack suture used	45 Participants	—	—	—	—	—
Procedural Endpoint: Descriptive Procedural Parameters - Use of Tack Sutures Corpus spongiosum	37 Participants	—	—	—	—	—
Procedural Endpoint: Descriptive Procedural Parameters - Use of Tack Sutures Perineal body	16 Participants	—	—	—	—	—
Procedural Endpoint: Descriptive Procedural Parameters - Use of Tack Sutures Other tack suture	9 Participants	—	—	—	—	—

PRIMARY outcome

Timeframe: During Procedure, Approximately 60 Minutes

Characterize procedural parameters, including muscle dissection across all participants.

Outcome measures

Measure	Treated Participants n=50 Participants Participants in which a device placement was attempted.	6 Month 6 Month Follow-Up Visit	12 Month 12 Month Follow-Up Visit	24 Month 24 Month Follow-Up Visit	24 Month LOCF 24 Month Visit using Last Observation Carried Forward	24 Month WCS 24 Month Visit using Worse Case Scenario
Procedural Endpoint: Descriptive Procedural Parameters - Muscle Dissection	50 Participants	—	—	—	—	—

PRIMARY outcome

Timeframe: During Procedure, Approximately 60 Minutes

Characterize procedural parameters, including the movement of urethral bulb while tensioning in all participants.

Outcome measures

Measure	Treated Participants n=50 Participants Participants in which a device placement was attempted.	6 Month 6 Month Follow-Up Visit	12 Month 12 Month Follow-Up Visit	24 Month 24 Month Follow-Up Visit	24 Month LOCF 24 Month Visit using Last Observation Carried Forward	24 Month WCS 24 Month Visit using Worse Case Scenario
Procedural Endpoint: Descriptive Procedural Parameters - Movement of Urethral Bulb While Tensioning 2 cm	5 Participants	—	—	—	—	—
Procedural Endpoint: Descriptive Procedural Parameters - Movement of Urethral Bulb While Tensioning 3 cm	34 Participants	—	—	—	—	—
Procedural Endpoint: Descriptive Procedural Parameters - Movement of Urethral Bulb While Tensioning > 3 cm	11 Participants	—	—	—	—	—

PRIMARY outcome

Timeframe: During Procedure, Approximately 60 Minutes

Summarize device success as defined as a successful placement of the device in a desired position, peri-operatively, in participants.

Outcome measures

Measure	Treated Participants n=50 Participants Participants in which a device placement was attempted.	6 Month 6 Month Follow-Up Visit	12 Month 12 Month Follow-Up Visit	24 Month 24 Month Follow-Up Visit	24 Month LOCF 24 Month Visit using Last Observation Carried Forward	24 Month WCS 24 Month Visit using Worse Case Scenario
Device Success as Defined as Successful Placement of the Device in Desired Position Peri-operatively	49 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline to 24 month

Population: Last observation carried forward (LOCF) and worst case scenario (WCS) data are derived from data from the 24 month visit

Summarize subject satisfaction of 1-hour pad weight for participants.

Outcome measures

Measure	Treated Participants n=50 Participants Participants in which a device placement was attempted.	6 Month 6 Month Follow-Up Visit	12 Month 12 Month Follow-Up Visit	24 Month 24 Month Follow-Up Visit	24 Month LOCF 24 Month Visit using Last Observation Carried Forward	24 Month WCS 24 Month Visit using Worse Case Scenario
Subject Satisfaction Endpoint: 1-Hour Pad Weight Baseline	78.4 grams Standard Deviation 102.3	—	—	—	—	—
Subject Satisfaction Endpoint: 1-Hour Pad Weight 3 Month	8.9 grams Standard Deviation 24.2	—	—	—	—	—
Subject Satisfaction Endpoint: 1-Hour Pad Weight 6 Month	23.6 grams Standard Deviation 49.5	—	—	—	—	—
Subject Satisfaction Endpoint: 1-Hour Pad Weight 12 Month	15.8 grams Standard Deviation 29.7	—	—	—	—	—
Subject Satisfaction Endpoint: 1-Hour Pad Weight 24 Month	21.0 grams Standard Deviation 67.0	—	—	—	—	—
Subject Satisfaction Endpoint: 1-Hour Pad Weight 24 Month LOCF	22.2 grams Standard Deviation 59.2	—	—	—	—	—
Subject Satisfaction Endpoint: 1-Hour Pad Weight 24 Month WCS	30.5 grams Standard Deviation 76.1	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline to 24 month

Population: LOCF and WCS data are derived from data from the 24 month visit

Summarize subject satisfaction with 24-hour pad weight across participants.

Outcome measures

Measure	Treated Participants n=50 Participants Participants in which a device placement was attempted.	6 Month 6 Month Follow-Up Visit	12 Month 12 Month Follow-Up Visit	24 Month 24 Month Follow-Up Visit	24 Month LOCF 24 Month Visit using Last Observation Carried Forward	24 Month WCS 24 Month Visit using Worse Case Scenario
Subject Satisfaction Endpoint: 24-Hour Pad Weight 24 Month	38.3 grams Standard Deviation 58.8	—	—	—	—	—
Subject Satisfaction Endpoint: 24-Hour Pad Weight Baseline	377.2 grams Standard Deviation 657.5	—	—	—	—	—
Subject Satisfaction Endpoint: 24-Hour Pad Weight 3 Month	108.0 grams Standard Deviation 191.7	—	—	—	—	—
Subject Satisfaction Endpoint: 24-Hour Pad Weight 6 Month	53.7 grams Standard Deviation 99.1	—	—	—	—	—
Subject Satisfaction Endpoint: 24-Hour Pad Weight 12 Month	42.0 grams Standard Deviation 92.3	—	—	—	—	—
Subject Satisfaction Endpoint: 24-Hour Pad Weight 24 Month LOCF	73.0 grams Standard Deviation 131.2	—	—	—	—	—
Subject Satisfaction Endpoint: 24-Hour Pad Weight 24 Month WCS	110.0 grams Standard Deviation 244.1	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline to 24 month

Summarize the percent of subjects that have a decrease of pad weight of 25%, 50%, or 75% at follow-up (1-hour pad weight test used).

Outcome measures

Measure	Treated Participants n=39 Participants Participants in which a device placement was attempted.	6 Month n=37 Participants 6 Month Follow-Up Visit	12 Month n=33 Participants 12 Month Follow-Up Visit	24 Month n=29 Participants 24 Month Follow-Up Visit	24 Month LOCF n=41 Participants 24 Month Visit using Last Observation Carried Forward	24 Month WCS n=48 Participants 24 Month Visit using Worse Case Scenario
Subject Satisfaction Endpoint: Percentage of Subjects Having a Decrease of Pad Weight of 25%, 50%, or 75% at Follow-Up. (1 Hour Pad Weight Test) 1-Hour ≥ 25% Reduction in Pad Weight	34 participants	28 participants	29 participants	25 participants	34 participants	34 participants
Subject Satisfaction Endpoint: Percentage of Subjects Having a Decrease of Pad Weight of 25%, 50%, or 75% at Follow-Up. (1 Hour Pad Weight Test) 1-Hour ≥ 50% Reduction in Pad Weight	32 participants	25 participants	25 participants	24 participants	31 participants	31 participants
Subject Satisfaction Endpoint: Percentage of Subjects Having a Decrease of Pad Weight of 25%, 50%, or 75% at Follow-Up. (1 Hour Pad Weight Test) 1-Hour ≥ 75% Reduction in Pad Weight	26 participants	24 participants	23 participants	20 participants	26 participants	26 participants

SECONDARY outcome

Timeframe: Baseline to 24 Month

Summarize the percent of subjects that have a decrease of pad weight of 25%, 50%, or 75% at follow-up (24-hour pad weight test used).

Outcome measures

Measure	Treated Participants n=32 Participants Participants in which a device placement was attempted.	6 Month n=30 Participants 6 Month Follow-Up Visit	12 Month n=31 Participants 12 Month Follow-Up Visit	24 Month n=28 Participants 24 Month Follow-Up Visit	24 Month LOCF n=42 Participants 24 Month Visit using Last Observation Carried Forward	24 Month WCS n=48 Participants 24 Month Visit using Worse Case Scenario
Subject Satisfaction Endpoint: Percentage of Subjects Having a Decrease of Pad Weight of 25%, 50%, or 75% at Follow-Up. (24 Hour Pad Weight Test) 24-Hour ≥ 25% Reduction in Pad Weight	26 participants	28 participants	29 participants	26 participants	36 participants	36 participants
Subject Satisfaction Endpoint: Percentage of Subjects Having a Decrease of Pad Weight of 25%, 50%, or 75% at Follow-Up. (24 Hour Pad Weight Test) 24-Hour ≥ 50% Reduction in Pad Weight	24 participants	24 participants	27 participants	26 participants	34 participants	34 participants
Subject Satisfaction Endpoint: Percentage of Subjects Having a Decrease of Pad Weight of 25%, 50%, or 75% at Follow-Up. (24 Hour Pad Weight Test) 24-Hour ≥ 75% Reduction in Pad Weight	20 participants	22 participants	25 participants	20 participants	26 participants	26 participants

SECONDARY outcome

Timeframe: Baseline to 24 Months

Population: LOCF and WCS data are derived from data from the 24 month visit

Summarize the subject satisfaction using pads per day use collected in follow-up in participants.

Outcome measures

Measure	Treated Participants n=50 Participants Participants in which a device placement was attempted.	6 Month n=50 Participants 6 Month Follow-Up Visit	12 Month n=50 Participants 12 Month Follow-Up Visit	24 Month n=50 Participants 24 Month Follow-Up Visit	24 Month LOCF n=50 Participants 24 Month Visit using Last Observation Carried Forward	24 Month WCS 24 Month Visit using Worse Case Scenario
Subject Satisfaction Endpoint: Pads Per Day Use 24 Month LOCF	25 Participants	15 Participants	3 Participants	3 Participants	3 Participants	—
Subject Satisfaction Endpoint: Pads Per Day Use 24 Month WCS	25 Participants	15 Participants	3 Participants	3 Participants	3 Participants	—
Subject Satisfaction Endpoint: Pads Per Day Use 3 Month	34 Participants	6 Participants	2 Participants	2 Participants	0 Participants	—
Subject Satisfaction Endpoint: Pads Per Day Use 6 Month	32 Participants	4 Participants	3 Participants	0 Participants	0 Participants	—
Subject Satisfaction Endpoint: Pads Per Day Use 24 Month	21 Participants	9 Participants	1 Participants	0 Participants	0 Participants	—
Subject Satisfaction Endpoint: Pads Per Day Use Baseline	7 Participants	20 Participants	13 Participants	8 Participants	1 Participants	—
Subject Satisfaction Endpoint: Pads Per Day Use 6 Week	33 Participants	8 Participants	2 Participants	2 Participants	3 Participants	—
Subject Satisfaction Endpoint: Pads Per Day Use 12 Month	26 Participants	7 Participants	2 Participants	1 Participants	1 Participants	—

SECONDARY outcome

Timeframe: Baseline to 24 Months

Population: Number of subjects that did not have test performed at follow-up visit.

The Incontinence Quality of Life (I-QOL) questionnaire contains 22 items, each with a 5-point Likert-type response scale, evaluating a subject's quality of life with respect to his urinary problems or incontinence. A possible total score can be 0-100, with a higher score meaning less problems.

Outcome measures

Measure	Treated Participants n=50 Participants Participants in which a device placement was attempted.	6 Month 6 Month Follow-Up Visit	12 Month 12 Month Follow-Up Visit	24 Month 24 Month Follow-Up Visit	24 Month LOCF 24 Month Visit using Last Observation Carried Forward	24 Month WCS 24 Month Visit using Worse Case Scenario
Subject Satisfaction Endpoint: Quality of Life I-QOL Scores Baseline	50.3 score Standard Deviation 22.4	—	—	—	—	—
Subject Satisfaction Endpoint: Quality of Life I-QOL Scores 6 Month	79.4 score Standard Deviation 21.6	—	—	—	—	—
Subject Satisfaction Endpoint: Quality of Life I-QOL Scores 12 Month	79.9 score Standard Deviation 22.9	—	—	—	—	—
Subject Satisfaction Endpoint: Quality of Life I-QOL Scores 24 Month	82.4 score Standard Deviation 18.3	—	—	—	—	—
Subject Satisfaction Endpoint: Quality of Life I-QOL Scores 3 Month	79.2 score Standard Deviation 20.9	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline to 24 Months

Population: Number of subjects that did not have test performed at follow-up visit.

The ICIQ-SF questionnaire evaluates the impact of urinary incontinence on quality of life through four questions that evaluate the frequency, severity and impact of urinary incontinence. A set of eight self-diagnosis items related to the causes or situations of urinary incontinence experienced by the subject are also assessed. Scores may range from 0 to 21. Improvement in the subject's quality of life from baseline to follow-up is indicated by a decrease in the ICIQ-SF score.

Outcome measures

Measure	Treated Participants n=50 Participants Participants in which a device placement was attempted.	6 Month 6 Month Follow-Up Visit	12 Month 12 Month Follow-Up Visit	24 Month 24 Month Follow-Up Visit	24 Month LOCF 24 Month Visit using Last Observation Carried Forward	24 Month WCS 24 Month Visit using Worse Case Scenario
Subject Satisfaction Endpoint: Quality of Life International Consultation on Incontinence Questionnaire Short-Form (ICIQ-SF) Scores Baseline	15.7 score Standard Deviation 4.1	—	—	—	—	—
Subject Satisfaction Endpoint: Quality of Life International Consultation on Incontinence Questionnaire Short-Form (ICIQ-SF) Scores 3 Month	7.6 score Standard Deviation 5.6	—	—	—	—	—
Subject Satisfaction Endpoint: Quality of Life International Consultation on Incontinence Questionnaire Short-Form (ICIQ-SF) Scores 6 Month	7.6 score Standard Deviation 5.7	—	—	—	—	—
Subject Satisfaction Endpoint: Quality of Life International Consultation on Incontinence Questionnaire Short-Form (ICIQ-SF) Scores 12 Month	7.3 score Standard Deviation 5.8	—	—	—	—	—
Subject Satisfaction Endpoint: Quality of Life International Consultation on Incontinence Questionnaire Short-Form (ICIQ-SF) Scores 24 Month	7.5 score Standard Deviation 5.5	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline to 24 Months

Population: Number of subjects that did not have test performed at follow-up visit.

Improvement in the subject's quality of life from baseline to follow-up is indicated by an increase in the UCLA/RAND urinary function score. Scores may range from 0 to 100.

Outcome measures

Measure	Treated Participants n=50 Participants Participants in which a device placement was attempted.	6 Month 6 Month Follow-Up Visit	12 Month 12 Month Follow-Up Visit	24 Month 24 Month Follow-Up Visit	24 Month LOCF 24 Month Visit using Last Observation Carried Forward	24 Month WCS 24 Month Visit using Worse Case Scenario
Subject Satisfaction Endpoint: Quality of Life UCLA (University of California Los Angeles) / RAND (RAND Corporation) Scores 6 Month	55.9 score Standard Deviation 28.8	—	—	—	—	—
Subject Satisfaction Endpoint: Quality of Life UCLA (University of California Los Angeles) / RAND (RAND Corporation) Scores 12 Month	57.4 score Standard Deviation 29.1	—	—	—	—	—
Subject Satisfaction Endpoint: Quality of Life UCLA (University of California Los Angeles) / RAND (RAND Corporation) Scores Baseline	20.1 score Standard Deviation 14.3	—	—	—	—	—
Subject Satisfaction Endpoint: Quality of Life UCLA (University of California Los Angeles) / RAND (RAND Corporation) Scores 3 Month	54.7 score Standard Deviation 28.7	—	—	—	—	—
Subject Satisfaction Endpoint: Quality of Life UCLA (University of California Los Angeles) / RAND (RAND Corporation) Scores 24 Month	57.3 score Standard Deviation 27.1	—	—	—	—	—

SECONDARY outcome

Timeframe: 6 Weeks post implant to 24 Months

Physician evaluation of subject's incontinence status at 6 weeks and subsequent follow-up evaluations

Outcome measures

Measure	Treated Participants n=50 Participants Participants in which a device placement was attempted.	6 Month n=50 Participants 6 Month Follow-Up Visit	12 Month n=50 Participants 12 Month Follow-Up Visit	24 Month n=50 Participants 24 Month Follow-Up Visit	24 Month LOCF 24 Month Visit using Last Observation Carried Forward	24 Month WCS 24 Month Visit using Worse Case Scenario
Subject Satisfaction Endpoint: Physician Evaluation of Subject's Incontinence Status 6 Week	12 Participants	17 Participants	12 Participants	7 Participants	—	—
Subject Satisfaction Endpoint: Physician Evaluation of Subject's Incontinence Status 3 Month	12 Participants	14 Participants	15 Participants	3 Participants	—	—
Subject Satisfaction Endpoint: Physician Evaluation of Subject's Incontinence Status 6 Month	12 Participants	11 Participants	14 Participants	2 Participants	—	—
Subject Satisfaction Endpoint: Physician Evaluation of Subject's Incontinence Status 12 Month	9 Participants	15 Participants	9 Participants	4 Participants	—	—
Subject Satisfaction Endpoint: Physician Evaluation of Subject's Incontinence Status 24 Month	7 Participants	12 Participants	11 Participants	1 Participants	—	—

SECONDARY outcome

Timeframe: Procedure to 24 Months Post implant

Percentage of participants with serious and non-serious adverse events.

Outcome measures

Measure	Treated Participants n=50 Participants Participants in which a device placement was attempted.	6 Month 6 Month Follow-Up Visit	12 Month 12 Month Follow-Up Visit	24 Month 24 Month Follow-Up Visit	24 Month LOCF 24 Month Visit using Last Observation Carried Forward	24 Month WCS 24 Month Visit using Worse Case Scenario
Procedural and Device Complication Rates	54 percentage of participants	—	—	—	—	—

POST_HOC outcome

Timeframe: Baseline to 24 month

Population: Number of subjects that did not have test performed at follow-up visit.

Baseline uroflow measurements including peak flow rates, average flow rates, voided volume, and post-void residual were compared to follow-up results at 3, 6, 12, and 24 months.

Outcome measures

Measure	Treated Participants n=50 Participants Participants in which a device placement was attempted.	6 Month 6 Month Follow-Up Visit	12 Month 12 Month Follow-Up Visit	24 Month 24 Month Follow-Up Visit	24 Month LOCF 24 Month Visit using Last Observation Carried Forward	24 Month WCS 24 Month Visit using Worse Case Scenario
Uroflow Studies: Peak Flow Rate Baseline	20.8 ml/sec Standard Deviation 11.3	—	—	—	—	—
Uroflow Studies: Peak Flow Rate 3 Month	20.9 ml/sec Standard Deviation 13.5	—	—	—	—	—
Uroflow Studies: Peak Flow Rate 6 Month	19.8 ml/sec Standard Deviation 13.8	—	—	—	—	—
Uroflow Studies: Peak Flow Rate 12 Month	19.4 ml/sec Standard Deviation 8.4	—	—	—	—	—
Uroflow Studies: Peak Flow Rate 24 Month	20.1 ml/sec Standard Deviation 8.5	—	—	—	—	—

POST_HOC outcome

Timeframe: Baseline to 24 Month

Population: Number of subjects that did not have test performed at follow-up visit.

Baseline uroflow measurements including peak flow rates, average flow rates, voided volume, and post-void residual were compared to follow-up results at 3, 6, 12, and 24 months.

Outcome measures

Measure	Treated Participants n=50 Participants Participants in which a device placement was attempted.	6 Month 6 Month Follow-Up Visit	12 Month 12 Month Follow-Up Visit	24 Month 24 Month Follow-Up Visit	24 Month LOCF 24 Month Visit using Last Observation Carried Forward	24 Month WCS 24 Month Visit using Worse Case Scenario
Uroflow Studies: Average Flow Rates 24 Month	11.5 ml/sec Standard Deviation 5.8	—	—	—	—	—
Uroflow Studies: Average Flow Rates Baseline	12.0 ml/sec Standard Deviation 6.0	—	—	—	—	—
Uroflow Studies: Average Flow Rates 3 Month	11.1 ml/sec Standard Deviation 7.0	—	—	—	—	—
Uroflow Studies: Average Flow Rates 6 Month	11.3 ml/sec Standard Deviation 9.8	—	—	—	—	—
Uroflow Studies: Average Flow Rates 12 Month	10.9 ml/sec Standard Deviation 4.9	—	—	—	—	—

POST_HOC outcome

Timeframe: Baseline to 24 Months

Population: Number of subjects that did not have test performed at follow-up visit.

Baseline uroflow measurements including peak flow rates, average flow rates, voided volume, and post-void residual were compared to follow-up results at 3, 6, 12, and 24 months.

Outcome measures

Measure	Treated Participants n=50 Participants Participants in which a device placement was attempted.	6 Month 6 Month Follow-Up Visit	12 Month 12 Month Follow-Up Visit	24 Month 24 Month Follow-Up Visit	24 Month LOCF 24 Month Visit using Last Observation Carried Forward	24 Month WCS 24 Month Visit using Worse Case Scenario
Uroflow Studies: Voided Volume Baseline	280.8 ml Standard Deviation 112.4	—	—	—	—	—
Uroflow Studies: Voided Volume 3 Month	263.0 ml Standard Deviation 142.6	—	—	—	—	—
Uroflow Studies: Voided Volume 6 Month	244.2 ml Standard Deviation 114.3	—	—	—	—	—
Uroflow Studies: Voided Volume 12 Month	248.7 ml Standard Deviation 134.4	—	—	—	—	—
Uroflow Studies: Voided Volume 24 Month	298.6 ml Standard Deviation 147.4	—	—	—	—	—

POST_HOC outcome

Timeframe: Baseline to 24 Months

Population: Number of subjects that did not have test performed at follow-up visit.

Baseline uroflow measurements including peak flow rates, average flow rates, voided volume, and post-void residual were compared to follow-up results at 3, 6, 12, and 24 months.

Outcome measures

Measure	Treated Participants n=50 Participants Participants in which a device placement was attempted.	6 Month 6 Month Follow-Up Visit	12 Month 12 Month Follow-Up Visit	24 Month 24 Month Follow-Up Visit	24 Month LOCF 24 Month Visit using Last Observation Carried Forward	24 Month WCS 24 Month Visit using Worse Case Scenario
Uroflow Studies: Post-Void Residual 12 Month	13.1 ml Standard Deviation 30.0	—	—	—	—	—
Uroflow Studies: Post-Void Residual 24 Month	18.2 ml Standard Deviation 28.8	—	—	—	—	—
Uroflow Studies: Post-Void Residual Baseline	17.0 ml Standard Deviation 27.8	—	—	—	—	—
Uroflow Studies: Post-Void Residual 3 Month	17.7 ml Standard Deviation 31.1	—	—	—	—	—
Uroflow Studies: Post-Void Residual 6 Month	23.8 ml Standard Deviation 41.7	—	—	—	—	—

POST_HOC outcome

Timeframe: Baseline and 6 Months Post implant

Population: Number of subjects that did not have test performed at follow-up visit.

Baseline urodynamic measurements including bladder capacity, maximum detrusor pressure, detrusor pressure at maximum flow, and detrusor instability were measured at baseline and at 6-month follow-up.

Outcome measures

Measure	Treated Participants n=50 Participants Participants in which a device placement was attempted.	6 Month 6 Month Follow-Up Visit	12 Month 12 Month Follow-Up Visit	24 Month 24 Month Follow-Up Visit	24 Month LOCF 24 Month Visit using Last Observation Carried Forward	24 Month WCS 24 Month Visit using Worse Case Scenario
Urodynamic Results: Bladder Capacity Baseline	323.5 ml Standard Deviation 130.8	—	—	—	—	—
Urodynamic Results: Bladder Capacity 6 Month	349.4 ml Standard Deviation 136.7	—	—	—	—	—

POST_HOC outcome

Timeframe: Baseline and 6 Months Post Implant

Population: Number of subjects that did not have test performed at follow-up visit.

Baseline urodynamic measurements including bladder capacity, maximum detrusor pressure, detrusor pressure at maximum flow, and detrusor instability were measured at baseline and at 6-month follow-up.

Maximum detrusor pressure is measured during a urodynamic study when tension is applied to the bladder wall (detrusor muscles) by filling the bladder to capacity with saline water and observing the detrusor muscle during filling of the bladder and voiding of the saline water.

Outcome measures

Measure	Treated Participants n=50 Participants Participants in which a device placement was attempted.	6 Month 6 Month Follow-Up Visit	12 Month 12 Month Follow-Up Visit	24 Month 24 Month Follow-Up Visit	24 Month LOCF 24 Month Visit using Last Observation Carried Forward	24 Month WCS 24 Month Visit using Worse Case Scenario
Urodynamics Results: Maximum Detrusor Pressure Baseline	35.9 cm H2O Standard Deviation 27.4	—	—	—	—	—
Urodynamics Results: Maximum Detrusor Pressure 6 Months	32.3 cm H2O Standard Deviation 21.3	—	—	—	—	—

POST_HOC outcome

Timeframe: Baseline and 6 Months Post Implant

Population: Number of subjects that did not have test performed at follow-up visit.

Baseline urodynamic measurements including bladder capacity, maximum detrusor pressure, detrusor pressure at maximum flow, and detrusor instability were measured at baseline and at 6-month follow-up.

Maximum detrusor pressure is measured during a urodynamic study when tension is applied to the bladder wall (detrusor muscles) by filling the bladder to capacity with saline water and observing the detrusor muscle during filling of the bladder and voiding of the saline water. Pdet at Qmax is the detrusor pressure at maximal flow rate when the bladder is full and the patient begins voiding.

Outcome measures

Measure	Treated Participants n=50 Participants Participants in which a device placement was attempted.	6 Month 6 Month Follow-Up Visit	12 Month 12 Month Follow-Up Visit	24 Month 24 Month Follow-Up Visit	24 Month LOCF 24 Month Visit using Last Observation Carried Forward	24 Month WCS 24 Month Visit using Worse Case Scenario
Urodynamics Results: Pdet at Qmax Baseline	26.2 cm H20 Standard Deviation 19.3	—	—	—	—	—
Urodynamics Results: Pdet at Qmax 6 Months	30.2 cm H20 Standard Deviation 17.1	—	—	—	—	—

POST_HOC outcome

Timeframe: Baseline and 6 Months Post Implant

Population: Number of subjects that did not have test performed at follow-up visit.

Baseline urodynamic measurements including bladder capacity, maximum detrusor pressure, detrusor pressure at maximum flow, and detrusor instability were measured at baseline and at 6-month follow-up.

Detrusor instability occurs when the detrusor muscle is unstable and spontaneously contracts the bladder.

The measure data table shows the mean volume at the start of the urodynamic measurement study for patients with detrusor instability.

Outcome measures

Measure	Treated Participants n=50 Participants Participants in which a device placement was attempted.	6 Month 6 Month Follow-Up Visit	12 Month 12 Month Follow-Up Visit	24 Month 24 Month Follow-Up Visit	24 Month LOCF 24 Month Visit using Last Observation Carried Forward	24 Month WCS 24 Month Visit using Worse Case Scenario
Urodynamics Results: Detrusor Instability, Started at Filling Volume Baseline	225.8 ml Standard Deviation 159.9	—	—	—	—	—
Urodynamics Results: Detrusor Instability, Started at Filling Volume 6 Month	170.8 ml Standard Deviation 32.1	—	—	—	—	—

POST_HOC outcome

Timeframe: Baseline and 6 Months Post Implant

Population: Number of subjects that did not have test performed at follow-up visit.

Baseline urodynamic measurements including bladder capacity, maximum detrusor pressure, detrusor pressure at maximum flow, and detrusor instability were measured at baseline and at 6-month follow-up.

Maximum detrusor pressure is measured during a urodynamic study when tension is applied to the bladder wall (detrusor muscles) by filling the bladder to capacity with saline water and observing the detrusor muscle during filling of the bladder and voiding of the saline water. Pdet at Qmax is the detrusor pressure at maximal flow rate when the bladder is full and the patient begins voiding.

Detrusor instability occurs when the detrusor muscle is unstable and spontaneously contracts the bladder.

The outcome measure data table shows the Pdet for patients with detrusor instability.

Outcome measures

Measure	Treated Participants n=50 Participants Participants in which a device placement was attempted.	6 Month 6 Month Follow-Up Visit	12 Month 12 Month Follow-Up Visit	24 Month 24 Month Follow-Up Visit	24 Month LOCF 24 Month Visit using Last Observation Carried Forward	24 Month WCS 24 Month Visit using Worse Case Scenario
Urodynamics Results: Detrusor Instability, Max Pdet Baseline	31.5 cm H2O Standard Deviation 31.3	—	—	—	—	—
Urodynamics Results: Detrusor Instability, Max Pdet 6 Month	41.0 cm H2O Standard Deviation 37.8	—	—	—	—	—

POST_HOC outcome

Timeframe: Baseline and 6 Months Post Implant

Population: Number of subjects that did not have test performed at follow-up visit.

Baseline urodynamic measurements including bladder capacity, maximum detrusor pressure, detrusor pressure at maximum flow, and detrusor instability were measured at baseline and at 6-month follow-up.

Abnormal graphical representation of bladder pressure during urodynamics testing which is when the bladder is filled with saline water.

Outcome measures

Measure	Treated Participants n=50 Participants Participants in which a device placement was attempted.	6 Month 6 Month Follow-Up Visit	12 Month 12 Month Follow-Up Visit	24 Month 24 Month Follow-Up Visit	24 Month LOCF 24 Month Visit using Last Observation Carried Forward	24 Month WCS 24 Month Visit using Worse Case Scenario
Urodynamics Results: Abnormal Cystometrogram, Abnormal End Fill Pressure Baseline	10.0 cm H2O Standard Deviation 8.3	—	—	—	—	—
Urodynamics Results: Abnormal Cystometrogram, Abnormal End Fill Pressure 6 Month	6.0 cm H2O Standard Deviation 0	—	—	—	—	—

POST_HOC outcome

Timeframe: Baseline and 6 Months Post Implant

Population: 18 participants did not have 6-month follow-up data

Abdominal leak point pressure (ALPP) is one indicator of improvement in continence symptoms. Abdominal leak point pressure was collected at baseline and 6-month follow-up as part of the urodynamic assessment.

Outcome measures

Measure	Treated Participants n=31 Participants Participants in which a device placement was attempted.	6 Month 6 Month Follow-Up Visit	12 Month 12 Month Follow-Up Visit	24 Month 24 Month Follow-Up Visit	24 Month LOCF 24 Month Visit using Last Observation Carried Forward	24 Month WCS 24 Month Visit using Worse Case Scenario
Urodynamic Results: Abdominal Leak Point Pressure Improved: leaked @ baseline, improved @ 6 months	10 participants	—	—	—	—	—
Urodynamic Results: Abdominal Leak Point Pressure Improved: leaked @ baseline, no leak @ 6 months	14 participants	—	—	—	—	—
Urodynamic Results: Abdominal Leak Point Pressure Unchanged: leaked same at baseline and 6 months	1 participants	—	—	—	—	—
Urodynamic Results: Abdominal Leak Point Pressure Worsened: no leak @ baseline, leak @ 6 months	1 participants	—	—	—	—	—
Urodynamic Results: Abdominal Leak Point Pressure Unchanged: no leak @ baseline, no leak @ 6 months	1 participants	—	—	—	—	—
Urodynamic Results: Abdominal Leak Point Pressure Worsened: leaked @ baseline, leaked more at 6 mo	4 participants	—	—	—	—	—

Adverse Events

Treated Participants

Serious events: 2 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treated Participants n=50 participants at risk Participants in which a device placement was attempted.
Renal and urinary disorders Urinary Incontinence - Persistant	2.0% 1/50 • Number of events 1 • Adverse events were collected at the implant, 6 weeks, 3 month, 6 month, 12 month, and 24 month visits. Only adverse events related to the study device or procedure are displayed.
Vascular disorders Intra-operative Bleeding of Aberrant Vessel	2.0% 1/50 • Number of events 1 • Adverse events were collected at the implant, 6 weeks, 3 month, 6 month, 12 month, and 24 month visits. Only adverse events related to the study device or procedure are displayed.

Other adverse events

Measure	Treated Participants n=50 participants at risk Participants in which a device placement was attempted.
General disorders Pain/ Discomfort	16.0% 8/50 • Number of events 11 • Adverse events were collected at the implant, 6 weeks, 3 month, 6 month, 12 month, and 24 month visits. Only adverse events related to the study device or procedure are displayed.
Renal and urinary disorders Urinary retention	20.0% 10/50 • Number of events 10 • Adverse events were collected at the implant, 6 weeks, 3 month, 6 month, 12 month, and 24 month visits. Only adverse events related to the study device or procedure are displayed.
Renal and urinary disorders Urinary Incontinence - Persistent	6.0% 3/50 • Number of events 3 • Adverse events were collected at the implant, 6 weeks, 3 month, 6 month, 12 month, and 24 month visits. Only adverse events related to the study device or procedure are displayed.
Renal and urinary disorders Urinary Urgency	4.0% 2/50 • Number of events 2 • Adverse events were collected at the implant, 6 weeks, 3 month, 6 month, 12 month, and 24 month visits. Only adverse events related to the study device or procedure are displayed.
Injury, poisoning and procedural complications Ecchymosis	4.0% 2/50 • Number of events 2 • Adverse events were collected at the implant, 6 weeks, 3 month, 6 month, 12 month, and 24 month visits. Only adverse events related to the study device or procedure are displayed.
Renal and urinary disorders Post-Void Dribbling	4.0% 2/50 • Number of events 2 • Adverse events were collected at the implant, 6 weeks, 3 month, 6 month, 12 month, and 24 month visits. Only adverse events related to the study device or procedure are displayed.
Reproductive system and breast disorders Pain/ Discomfort With Erections	2.0% 1/50 • Number of events 1 • Adverse events were collected at the implant, 6 weeks, 3 month, 6 month, 12 month, and 24 month visits. Only adverse events related to the study device or procedure are displayed.
Renal and urinary disorders Urinary Incontinence - De Novo Stress	2.0% 1/50 • Number of events 1 • Adverse events were collected at the implant, 6 weeks, 3 month, 6 month, 12 month, and 24 month visits. Only adverse events related to the study device or procedure are displayed.
Injury, poisoning and procedural complications Scrotal Pain/ Swelling	2.0% 1/50 • Number of events 1 • Adverse events were collected at the implant, 6 weeks, 3 month, 6 month, 12 month, and 24 month visits. Only adverse events related to the study device or procedure are displayed.
Skin and subcutaneous tissue disorders Groin Rash	2.0% 1/50 • Number of events 1 • Adverse events were collected at the implant, 6 weeks, 3 month, 6 month, 12 month, and 24 month visits. Only adverse events related to the study device or procedure are displayed.
Musculoskeletal and connective tissue disorders Back Pain	2.0% 1/50 • Number of events 1 • Adverse events were collected at the implant, 6 weeks, 3 month, 6 month, 12 month, and 24 month visits. Only adverse events related to the study device or procedure are displayed.
Nervous system disorders Decreased Penile Sensitivity	2.0% 1/50 • Number of events 1 • Adverse events were collected at the implant, 6 weeks, 3 month, 6 month, 12 month, and 24 month visits. Only adverse events related to the study device or procedure are displayed.
Injury, poisoning and procedural complications Edema of Penis	2.0% 1/50 • Number of events 1 • Adverse events were collected at the implant, 6 weeks, 3 month, 6 month, 12 month, and 24 month visits. Only adverse events related to the study device or procedure are displayed.
Injury, poisoning and procedural complications Light Post-Op Bleed	2.0% 1/50 • Number of events 1 • Adverse events were collected at the implant, 6 weeks, 3 month, 6 month, 12 month, and 24 month visits. Only adverse events related to the study device or procedure are displayed.
Reproductive system and breast disorders Penile Pain with Orgasm	2.0% 1/50 • Number of events 1 • Adverse events were collected at the implant, 6 weeks, 3 month, 6 month, 12 month, and 24 month visits. Only adverse events related to the study device or procedure are displayed.
Renal and urinary disorders Worsening Incontinence	2.0% 1/50 • Number of events 1 • Adverse events were collected at the implant, 6 weeks, 3 month, 6 month, 12 month, and 24 month visits. Only adverse events related to the study device or procedure are displayed.

Additional Information

Laura Olson, Clinical Project Manager

American Medical System

Phone: 952-930-6000

Email: laura.olson2@bsci.com

Results disclosure agreements

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