Trial Outcomes & Findings for AMS AdVance and AdVance XP Male Sling Systems for the Treatment of Stress Urinary Incontinence Following Prostatectomy: Evaluation of Safety, Efficacy, and Quality of Life Through Retrospective Chart Review and Prospective Follow-up (NCT NCT01725984)

Results Overview

Evaluate the proportion of subjects with a ≥50% reduction in pads per day use

Recruitment status

COMPLETED

Target enrollment

80 participants

Primary outcome timeframe

3 Months Post Procedure

Results posted on

2015-06-30

Participant Flow

140 subjects were screened for inclusion into the study. 80 total subjects met all inclusion and none of the exclusion criteria.

Participant milestones

Participant milestones
Measure	AdVance Subjects previously implanted with the AdVance Male Sling	AdVance XP Subjects previously implanted with the AdVance XP male sling
Overall Study STARTED	39	41
Overall Study COMPLETED	39	41
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

AMS AdVance and AdVance XP Male Sling Systems for the Treatment of Stress Urinary Incontinence Following Prostatectomy: Evaluation of Safety, Efficacy, and Quality of Life Through Retrospective Chart Review and Prospective Follow-up

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AdVance n=39 Participants Subjects previously implanted with the AdVance Male Sling	AdVance XP n=41 Participants Subjects previously implanted with the AdVance XP male sling	Total n=80 Participants Total of all reporting groups
Age, Continuous	70.2 Years STANDARD_DEVIATION 4.9 • n=5 Participants	68.8 Years STANDARD_DEVIATION 5.3 • n=7 Participants	69.5 Years STANDARD_DEVIATION 5.1 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	39 Participants n=5 Participants	41 Participants n=7 Participants	80 Participants n=5 Participants
Region of Enrollment Germany	39 participants n=5 Participants	41 participants n=7 Participants	80 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 Months Post Procedure

Evaluate the proportion of subjects with a ≥50% reduction in pads per day use

Outcome measures

Outcome measures
Measure	AdVance n=39 Participants Subjects previously implanted with the AdVance Male Sling	AdVance XP n=41 Participants Subjects previously implanted with the AdVance XP male sling
Percentage of Subjects With a ≥50% Reduction in Pads Per Day Use	87.2 percentage of participants	97.6 percentage of participants

PRIMARY outcome

Timeframe: 3 months Post Procedure

Evaluate the proportion of subjects cured (0 pads per day or 1 dry prophylactic pad), improved (not cured and ≥50% reduction in pad use), or failed (not cured and not improved) at the three month and final prospective follow-up visit

Outcome measures

Outcome measures
Measure	AdVance n=39 Participants Subjects previously implanted with the AdVance Male Sling	AdVance XP n=41 Participants Subjects previously implanted with the AdVance XP male sling
Percentage of Subjects Cured, Improved, or Failed Based on Reported Pad Per Day Use Cured	79.5 percentage of subjects	82.9 percentage of subjects
Percentage of Subjects Cured, Improved, or Failed Based on Reported Pad Per Day Use Improved	7.7 percentage of subjects	14.6 percentage of subjects
Percentage of Subjects Cured, Improved, or Failed Based on Reported Pad Per Day Use Failed	12.8 percentage of subjects	2.4 percentage of subjects

PRIMARY outcome

Timeframe: Baseline

Evaluate the proportion of subjects using the following categories of pads per day at the three month and final prospective follow-up visit: 0 pads per day or 1 dry prophylactic pad; 1 pad per day; 2 pads per day; 3 pads per day; 4 pads per day; 5 or more pads per day (5, 6, 7, 8 etc. pads per day);

Outcome measures

Outcome measures
Measure	AdVance n=39 Participants Subjects previously implanted with the AdVance Male Sling	AdVance XP n=41 Participants Subjects previously implanted with the AdVance XP male sling
Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use 0 Pads per Day	0 percentage of subjects	0 percentage of subjects
Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use 1 Pad per Day	20.5 percentage of subjects	4.9 percentage of subjects
Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use 2 Pads per Day	15.4 percentage of subjects	26.8 percentage of subjects
Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use 3 Pads per Day	20.5 percentage of subjects	24.4 percentage of subjects
Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use 4 Pads per Day	12.8 percentage of subjects	7.3 percentage of subjects
Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use 5 or more Pads per Day	30.8 percentage of subjects	36.6 percentage of subjects

PRIMARY outcome

Timeframe: Prospective follow-up to 36 Months Post Procedure

Percentage of subjects at a given weight for their 24-hour pad weight test at the final prospective follow-up visit.

Outcome measures

Outcome measures
Measure	AdVance n=39 Participants Subjects previously implanted with the AdVance Male Sling	AdVance XP n=41 Participants Subjects previously implanted with the AdVance XP male sling
Evaluate the 24-hour Pad Weight at the Final Prospective Follow-up Visit 10g - 50g	30.8 percentage of subjects	22.0 percentage of subjects
Evaluate the 24-hour Pad Weight at the Final Prospective Follow-up Visit > 50g	10.3 percentage of subjects	9.8 percentage of subjects
Evaluate the 24-hour Pad Weight at the Final Prospective Follow-up Visit <= 10g	59.0 percentage of subjects	68.3 percentage of subjects

PRIMARY outcome

Timeframe: Baseline to Prospective Follow Up (up to 36 months)

The Incontinence Quality of Life Questionnaire (I-QOL) is a 22 questionnaire that evaluates a subject's quality of life with respect to urinary problems/incontinence. A lower score correlates with more severe incontinence, and an increase from baseline indicates an improvement in quality of life. The score scale is 0 - 100. The International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) is a 4 question tool that quantifies the impact on quality of life from incontinence. A decrease from baseline to follow-up indicates an improvement in quality of life. The score scale is 1-21. The Patient Global Impression of Improvement (PGI-I) questionnaire is a single question instrument that assess a subject's perception of the disease impact on their quality of life. Completed at the last visit, a lower score indicates a better perception from the patient. Scale from 1 to 7.

Outcome measures

Outcome measures
Measure	AdVance n=39 Participants Subjects previously implanted with the AdVance Male Sling	AdVance XP n=41 Participants Subjects previously implanted with the AdVance XP male sling
Change in Quality of Life Scores as Compared to Baseline for I-QOL, ICIQ-SF, and Summary of Values for the PGI-I. Measured From Baseline to Prospective Follow. IQOL Baseline	46.5 Score on a scale Standard Deviation 21.0	45.6 Score on a scale Standard Deviation 16.1
Change in Quality of Life Scores as Compared to Baseline for I-QOL, ICIQ-SF, and Summary of Values for the PGI-I. Measured From Baseline to Prospective Follow. IQOL 3 Month FU	81.4 Score on a scale Standard Deviation 21.5	85.4 Score on a scale Standard Deviation 17.8
Change in Quality of Life Scores as Compared to Baseline for I-QOL, ICIQ-SF, and Summary of Values for the PGI-I. Measured From Baseline to Prospective Follow. IQOL Prospective FU	79.9 Score on a scale Standard Deviation 21.7	86.8 Score on a scale Standard Deviation 17.4
Change in Quality of Life Scores as Compared to Baseline for I-QOL, ICIQ-SF, and Summary of Values for the PGI-I. Measured From Baseline to Prospective Follow. ICIQ-SF Baseline	14.4 Score on a scale Standard Deviation 5.1	15.9 Score on a scale Standard Deviation 3.5
Change in Quality of Life Scores as Compared to Baseline for I-QOL, ICIQ-SF, and Summary of Values for the PGI-I. Measured From Baseline to Prospective Follow. ICIQ-SF 3 Month FU	6.1 Score on a scale Standard Deviation 5.4	4.1 Score on a scale Standard Deviation 4.3
Change in Quality of Life Scores as Compared to Baseline for I-QOL, ICIQ-SF, and Summary of Values for the PGI-I. Measured From Baseline to Prospective Follow. ICIQ-SF Prospective FU	6.9 Score on a scale Standard Deviation 5.6	5.2 Score on a scale Standard Deviation 4.6
Change in Quality of Life Scores as Compared to Baseline for I-QOL, ICIQ-SF, and Summary of Values for the PGI-I. Measured From Baseline to Prospective Follow. PGI-I Prospective FU	1.7 Score on a scale Standard Deviation 1.1	1.4 Score on a scale Standard Deviation 1.1

PRIMARY outcome

Timeframe: Prospective follow-up to 36 Months Post Procedure

Evaluate the occurrence of all AdVance /AdVance XP AEs, as well as those reported as serious, intra-operative, device or procedure related adverse events

Outcome measures

Outcome measures
Measure	AdVance n=39 Participants Subjects previously implanted with the AdVance Male Sling	AdVance XP n=41 Participants Subjects previously implanted with the AdVance XP male sling
Number of Adverse Events Reported Between Arms Total Number of AEs	9 Adverse Events	12 Adverse Events
Number of Adverse Events Reported Between Arms Procedure Related AEs	8 Adverse Events	8 Adverse Events
Number of Adverse Events Reported Between Arms Device Related AEs	5 Adverse Events	8 Adverse Events
Number of Adverse Events Reported Between Arms Intra-operative	0 Adverse Events	0 Adverse Events
Number of Adverse Events Reported Between Arms Serious	2 Adverse Events	3 Adverse Events

PRIMARY outcome

Timeframe: Prospective follow-up to 36 Months Post Procedure

Evaluate the proportion of subjects with a ≥50% reduction in pads per day use

Outcome measures

Outcome measures
Measure	AdVance n=39 Participants Subjects previously implanted with the AdVance Male Sling	AdVance XP n=41 Participants Subjects previously implanted with the AdVance XP male sling
Percentage of Subjects With a ≥50% Reduction in Pads Per Day Use	69.2 percentage of subjects	90.2 percentage of subjects

PRIMARY outcome

Timeframe: Prospective follow-up to 36 Months Post Procedure

Evaluate the proportion of subjects cured (0 pads per day or 1 dry prophylactic pad), improved (not cured and ≥50% reduction in pad use), or failed (not cured and not improved) at the three month and final prospective follow-up visit

Outcome measures

Outcome measures
Measure	AdVance n=39 Participants Subjects previously implanted with the AdVance Male Sling	AdVance XP n=41 Participants Subjects previously implanted with the AdVance XP male sling
Percentage of Subjects Cured, Improved, or Failed Based on Reported Pad Per Day Use Cured	46.2 percentage of subjects	65.9 percentage of subjects
Percentage of Subjects Cured, Improved, or Failed Based on Reported Pad Per Day Use Improved	23.1 percentage of subjects	24.4 percentage of subjects
Percentage of Subjects Cured, Improved, or Failed Based on Reported Pad Per Day Use Failed	30.8 percentage of subjects	9.8 percentage of subjects

PRIMARY outcome

Timeframe: 3 Months Post Procedure

Evaluate the proportion of subjects using the following categories of pads per day at the three month and final prospective follow-up visit: 0 pads per day or 1 dry prophylactic pad; 1 pad per day; 2 pads per day; 3 pads per day; 4 pads per day; 5 or more pads per day (5, 6, 7, 8 etc. pads per day);

Outcome measures

Outcome measures
Measure	AdVance n=31 Participants Subjects previously implanted with the AdVance Male Sling	AdVance XP n=38 Participants Subjects previously implanted with the AdVance XP male sling
Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use 0 Pads per Day	87.1 percentage of subjects	86.8 percentage of subjects
Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use 1 Pad per Day	9.7 percentage of subjects	10.5 percentage of subjects
Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use 2 Pads per Day	3.2 percentage of subjects	2.6 percentage of subjects
Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use 3 Pads per Day	0 percentage of subjects	0 percentage of subjects
Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use 4 Pads per Day	0 percentage of subjects	0 percentage of subjects
Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use 5 Pads per Day	0 percentage of subjects	0 percentage of subjects

PRIMARY outcome

Timeframe: Prospective follow-up to 36 Months Post Procedure

Evaluate the proportion of subjects using the following categories of pads per day at the three month and final prospective follow-up visit: 0 pads per day or 1 dry prophylactic pad; 1 pad per day; 2 pads per day; 3 pads per day; 4 pads per day; 5 or more pads per day (5, 6, 7, 8 etc. pads per day);

Outcome measures

Outcome measures
Measure	AdVance n=39 Participants Subjects previously implanted with the AdVance Male Sling	AdVance XP n=41 Participants Subjects previously implanted with the AdVance XP male sling
Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use 0 Pads per Day	46.2 percentage of subjects	65.9 percentage of subjects
Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use 1 Pad per Day	23.1 percentage of subjects	12.2 percentage of subjects
Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use 2 Pads per Day	10.3 percentage of subjects	17.1 percentage of subjects
Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use 3 Pads per Day	12.8 percentage of subjects	0 percentage of subjects
Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use 4 Pads per Day	2.6 percentage of subjects	4.9 percentage of subjects
Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use 5 or more Pads per Day	5.1 percentage of subjects	0 percentage of subjects

Adverse Events

AdVance

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

AdVance XP

Serious events: 3 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	AdVance n=39 participants at risk Subjects implanted with the AdVance Male Sling	AdVance XP n=41 participants at risk Subjects implanted with the AdVance XP Male Sling
Infections and infestations Infection	2.6% 1/39 • Number of events 1 • All adverse events were collected during the study conductance between August 2012 and January 2013 (6 Months), and were reported from subjects between January 2010 to January 2013 (3 years).	0.00% 0/41 • All adverse events were collected during the study conductance between August 2012 and January 2013 (6 Months), and were reported from subjects between January 2010 to January 2013 (3 years).
Surgical and medical procedures Pain/Discomfort	2.6% 1/39 • Number of events 1 • All adverse events were collected during the study conductance between August 2012 and January 2013 (6 Months), and were reported from subjects between January 2010 to January 2013 (3 years).	0.00% 0/41 • All adverse events were collected during the study conductance between August 2012 and January 2013 (6 Months), and were reported from subjects between January 2010 to January 2013 (3 years).
Renal and urinary disorders Incontinence De Novo (Urge)	0.00% 0/39 • All adverse events were collected during the study conductance between August 2012 and January 2013 (6 Months), and were reported from subjects between January 2010 to January 2013 (3 years).	2.4% 1/41 • Number of events 1 • All adverse events were collected during the study conductance between August 2012 and January 2013 (6 Months), and were reported from subjects between January 2010 to January 2013 (3 years).
Renal and urinary disorders Urinary Retention	0.00% 0/39 • All adverse events were collected during the study conductance between August 2012 and January 2013 (6 Months), and were reported from subjects between January 2010 to January 2013 (3 years).	4.9% 2/41 • Number of events 2 • All adverse events were collected during the study conductance between August 2012 and January 2013 (6 Months), and were reported from subjects between January 2010 to January 2013 (3 years).

Other adverse events

Other adverse events
Measure	AdVance n=39 participants at risk Subjects implanted with the AdVance Male Sling	AdVance XP n=41 participants at risk Subjects implanted with the AdVance XP Male Sling
Renal and urinary disorders Elevated Post-Void Residual (PVR)	2.6% 1/39 • Number of events 1 • All adverse events were collected during the study conductance between August 2012 and January 2013 (6 Months), and were reported from subjects between January 2010 to January 2013 (3 years).	7.3% 3/41 • Number of events 3 • All adverse events were collected during the study conductance between August 2012 and January 2013 (6 Months), and were reported from subjects between January 2010 to January 2013 (3 years).
Renal and urinary disorders Superficial Wound Infection	2.6% 1/39 • Number of events 1 • All adverse events were collected during the study conductance between August 2012 and January 2013 (6 Months), and were reported from subjects between January 2010 to January 2013 (3 years).	0.00% 0/41 • All adverse events were collected during the study conductance between August 2012 and January 2013 (6 Months), and were reported from subjects between January 2010 to January 2013 (3 years).
Renal and urinary disorders Urinary Incontinence- De Novo (Stress)	2.6% 1/39 • Number of events 1 • All adverse events were collected during the study conductance between August 2012 and January 2013 (6 Months), and were reported from subjects between January 2010 to January 2013 (3 years).	4.9% 2/41 • Number of events 2 • All adverse events were collected during the study conductance between August 2012 and January 2013 (6 Months), and were reported from subjects between January 2010 to January 2013 (3 years).
Renal and urinary disorders Urinary Incontinence- De Novo (Urge)	2.6% 1/39 • Number of events 1 • All adverse events were collected during the study conductance between August 2012 and January 2013 (6 Months), and were reported from subjects between January 2010 to January 2013 (3 years).	0.00% 0/41 • All adverse events were collected during the study conductance between August 2012 and January 2013 (6 Months), and were reported from subjects between January 2010 to January 2013 (3 years).
Renal and urinary disorders Urinary Incontinence- Worsening Urge	0.00% 0/39 • All adverse events were collected during the study conductance between August 2012 and January 2013 (6 Months), and were reported from subjects between January 2010 to January 2013 (3 years).	2.4% 1/41 • Number of events 1 • All adverse events were collected during the study conductance between August 2012 and January 2013 (6 Months), and were reported from subjects between January 2010 to January 2013 (3 years).
Renal and urinary disorders Urinary Tract Infection	2.6% 1/39 • Number of events 1 • All adverse events were collected during the study conductance between August 2012 and January 2013 (6 Months), and were reported from subjects between January 2010 to January 2013 (3 years).	4.9% 2/41 • Number of events 2 • All adverse events were collected during the study conductance between August 2012 and January 2013 (6 Months), and were reported from subjects between January 2010 to January 2013 (3 years).
Renal and urinary disorders Urinary Urgency	5.1% 2/39 • Number of events 2 • All adverse events were collected during the study conductance between August 2012 and January 2013 (6 Months), and were reported from subjects between January 2010 to January 2013 (3 years).	2.4% 1/41 • Number of events 1 • All adverse events were collected during the study conductance between August 2012 and January 2013 (6 Months), and were reported from subjects between January 2010 to January 2013 (3 years).

Additional Information

Dr. Ricarda Bauer

Ludwig Maximilian Universität

Phone: +49 89 7095

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place