Intrinsic Sphincter Deficiency, Urinary Incontinence, Stress
Conditions
Keywords
Male Incontinence, AdVance Male Sling, AdVance XP Male Sling, Male Sling
Brief summary
A single-center retrospective chart review of AdVance and AdVance XP subject data, combined with prospective follow-up of the same subjects to confirm continence, adverse event, and quality of life status. This study includes patients previously implanted with an AdVance or AdVance XP male sling.
Detailed description
A single-center retrospective chart review of AdVance and AdVance XP subject data, combined with prospective follow-up of the same subjects to confirm continence, adverse event, and quality of life status. This study includes patients previously implanted with an AdVance or AdVance XP male sling.
Interventions
None listed
Sponsors
American Medical Systems
Study design
Observational model
COHORT
Eligibility
Sex/Gender
MALE
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Valid, written informed consent has been obtained 2. Male subject ≥40 years of age who received the AdVance male sling after January 1, 2010 or the AdVance XP male sling after July 1, 2010 for the treatment of post prostatectomy SUI 3. Pad use of 1 to 8 pads per day prior to sling placement (subjects who used only a dry prophylactic pad or safety liner at baseline will not be included) 4. External (distal) sphincter contractility and a coaptive zone of ≥ 1cm confirmed by endoscopic view prior to sling placement 5. Primary etiology of SUI resulting from radical prostatectomy including, simple open prostatectomy, robotic or laparoscopic prostatectomy
Exclusion criteria
1. Pad use of more than 8 pads per day prior to sling placement for incontinence management 2. Urine loss while lying in bed prior to sling placement 3. Treatment with a urethral sling system, an AMS Sphincter 800®, or any implanted device for the treatment of urinary incontinence (not including bulking agents) prior to sling placement 4. TURP procedure prior to sling placement 5. Urge predominant incontinence prior to sling placement 6. Past or current neurological disorder (e.g. neurogenic bladder, multiple sclerosis, Parkinson's disease) 7. History of connective tissue or autoimmune conditions 8. Past or current condition of compromised immune system 9. Placement of an inflatable penile prosthesis (IPP) after sling placement 10. Post void residual of \>50 ml prior to sling placement
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With a ≥50% Reduction in Pads Per Day Use | 3 Months Post Procedure | Evaluate the proportion of subjects with a ≥50% reduction in pads per day use |
| Percentage of Subjects Cured, Improved, or Failed Based on Reported Pad Per Day Use | 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 |
| Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use | 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); |
| Evaluate the 24-hour Pad Weight at the Final Prospective Follow-up Visit | 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. |
| 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. | 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. |
| Number of Adverse Events Reported Between Arms | 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 |
Countries
Germany
Participant flow
Recruitment details
140 subjects were screened for inclusion into the study. 80 total subjects met all inclusion and none of the exclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| AdVance Subjects previously implanted with the AdVance Male Sling | 39 |
| AdVance XP Subjects previously implanted with the AdVance XP male sling | 41 |
| Total | 80 |
Baseline characteristics
| Characteristic | AdVance | AdVance XP | Total |
|---|---|---|---|
| Age, Continuous | 70.2 Years STANDARD_DEVIATION 4.9 | 68.8 Years STANDARD_DEVIATION 5.3 | 69.5 Years STANDARD_DEVIATION 5.1 |
| Region of Enrollment Germany | 39 participants | 41 participants | 80 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 39 Participants | 41 Participants | 80 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 39 | 7 / 41 |
| serious Total, serious adverse events | 2 / 39 | 3 / 41 |
Outcome results
Primary
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.
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.
Time frame: Baseline to Prospective Follow Up (up to 36 months)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AdVance | 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 |
| AdVance | 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 |
| AdVance | 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 |
| AdVance | 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 |
| AdVance | 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 |
| AdVance | 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 |
| AdVance | 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 |
| AdVance XP | 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 | 1.4 Score on a scale | Standard Deviation 1.1 |
| AdVance XP | 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 | 45.6 Score on a scale | Standard Deviation 16.1 |
| AdVance XP | 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 | 85.4 Score on a scale | Standard Deviation 17.8 |
| AdVance XP | 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 | 86.8 Score on a scale | Standard Deviation 17.4 |
| AdVance XP | 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 | 15.9 Score on a scale | Standard Deviation 3.5 |
| AdVance XP | 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 | 4.1 Score on a scale | Standard Deviation 4.3 |
| AdVance XP | 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 | 5.2 Score on a scale | Standard Deviation 4.6 |
Primary
Evaluate the 24-hour Pad Weight at the Final Prospective Follow-up Visit
Percentage of subjects at a given weight for their 24-hour pad weight test at the final prospective follow-up visit.
Time frame: Prospective follow-up to 36 Months Post Procedure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AdVance | Evaluate the 24-hour Pad Weight at the Final Prospective Follow-up Visit | <= 10g | 59.0 percentage of subjects |
| AdVance | Evaluate the 24-hour Pad Weight at the Final Prospective Follow-up Visit | 10g - 50g | 30.8 percentage of subjects |
| AdVance | Evaluate the 24-hour Pad Weight at the Final Prospective Follow-up Visit | > 50g | 10.3 percentage of subjects |
| AdVance XP | Evaluate the 24-hour Pad Weight at the Final Prospective Follow-up Visit | <= 10g | 68.3 percentage of subjects |
| AdVance XP | Evaluate the 24-hour Pad Weight at the Final Prospective Follow-up Visit | 10g - 50g | 22.0 percentage of subjects |
| AdVance XP | Evaluate the 24-hour Pad Weight at the Final Prospective Follow-up Visit | > 50g | 9.8 percentage of subjects |
Primary
Number of Adverse Events Reported Between Arms
Evaluate the occurrence of all AdVance /AdVance XP AEs, as well as those reported as serious, intra-operative, device or procedure related adverse events
Time frame: Prospective follow-up to 36 Months Post Procedure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AdVance | Number of Adverse Events Reported Between Arms | Procedure Related AEs | 8 Adverse Events |
| AdVance | Number of Adverse Events Reported Between Arms | Intra-operative | 0 Adverse Events |
| AdVance | Number of Adverse Events Reported Between Arms | Device Related AEs | 5 Adverse Events |
| AdVance | Number of Adverse Events Reported Between Arms | Serious | 2 Adverse Events |
| AdVance | Number of Adverse Events Reported Between Arms | Total Number of AEs | 9 Adverse Events |
| AdVance XP | Number of Adverse Events Reported Between Arms | Serious | 3 Adverse Events |
| AdVance XP | Number of Adverse Events Reported Between Arms | Total Number of AEs | 12 Adverse Events |
| AdVance XP | Number of Adverse Events Reported Between Arms | Procedure Related AEs | 8 Adverse Events |
| AdVance XP | Number of Adverse Events Reported Between Arms | Device Related AEs | 8 Adverse Events |
| AdVance XP | Number of Adverse Events Reported Between Arms | Intra-operative | 0 Adverse Events |
Primary
Percentage of Subjects Cured, Improved, or Failed Based on Reported Pad Per Day Use
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
Time frame: Prospective follow-up to 36 Months Post Procedure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AdVance | Percentage of Subjects Cured, Improved, or Failed Based on Reported Pad Per Day Use | Cured | 46.2 percentage of subjects |
| AdVance | Percentage of Subjects Cured, Improved, or Failed Based on Reported Pad Per Day Use | Improved | 23.1 percentage of subjects |
| AdVance | Percentage of Subjects Cured, Improved, or Failed Based on Reported Pad Per Day Use | Failed | 30.8 percentage of subjects |
| AdVance XP | Percentage of Subjects Cured, Improved, or Failed Based on Reported Pad Per Day Use | Cured | 65.9 percentage of subjects |
| AdVance XP | Percentage of Subjects Cured, Improved, or Failed Based on Reported Pad Per Day Use | Improved | 24.4 percentage of subjects |
| AdVance XP | Percentage of Subjects Cured, Improved, or Failed Based on Reported Pad Per Day Use | Failed | 9.8 percentage of subjects |
Primary
Percentage of Subjects Cured, Improved, or Failed Based on Reported Pad Per Day Use
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
Time frame: 3 months Post Procedure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AdVance | Percentage of Subjects Cured, Improved, or Failed Based on Reported Pad Per Day Use | Improved | 7.7 percentage of subjects |
| AdVance | Percentage of Subjects Cured, Improved, or Failed Based on Reported Pad Per Day Use | Failed | 12.8 percentage of subjects |
| AdVance | Percentage of Subjects Cured, Improved, or Failed Based on Reported Pad Per Day Use | Cured | 79.5 percentage of subjects |
| AdVance XP | Percentage of Subjects Cured, Improved, or Failed Based on Reported Pad Per Day Use | Improved | 14.6 percentage of subjects |
| AdVance XP | Percentage of Subjects Cured, Improved, or Failed Based on Reported Pad Per Day Use | Cured | 82.9 percentage of subjects |
| AdVance XP | Percentage of Subjects Cured, Improved, or Failed Based on Reported Pad Per Day Use | Failed | 2.4 percentage of subjects |
Primary
Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use
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);
Time frame: Prospective follow-up to 36 Months Post Procedure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AdVance | Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use | 0 Pads per Day | 46.2 percentage of subjects |
| AdVance | Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use | 1 Pad per Day | 23.1 percentage of subjects |
| AdVance | Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use | 2 Pads per Day | 10.3 percentage of subjects |
| AdVance | Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use | 3 Pads per Day | 12.8 percentage of subjects |
| AdVance | Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use | 4 Pads per Day | 2.6 percentage of subjects |
| AdVance | Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use | 5 or more Pads per Day | 5.1 percentage of subjects |
| AdVance XP | Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use | 4 Pads per Day | 4.9 percentage of subjects |
| AdVance XP | Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use | 0 Pads per Day | 65.9 percentage of subjects |
| AdVance XP | Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use | 3 Pads per Day | 0 percentage of subjects |
| AdVance XP | Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use | 1 Pad per Day | 12.2 percentage of subjects |
| AdVance XP | Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use | 5 or more Pads per Day | 0 percentage of subjects |
| AdVance XP | Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use | 2 Pads per Day | 17.1 percentage of subjects |
Primary
Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use
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);
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AdVance | Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use | 0 Pads per Day | 0 percentage of subjects |
| AdVance | Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use | 1 Pad per Day | 20.5 percentage of subjects |
| AdVance | Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use | 2 Pads per Day | 15.4 percentage of subjects |
| AdVance | Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use | 3 Pads per Day | 20.5 percentage of subjects |
| AdVance | Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use | 4 Pads per Day | 12.8 percentage of subjects |
| AdVance | Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use | 5 or more Pads per Day | 30.8 percentage of subjects |
| AdVance XP | Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use | 4 Pads per Day | 7.3 percentage of subjects |
| AdVance XP | Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use | 0 Pads per Day | 0 percentage of subjects |
| AdVance XP | Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use | 3 Pads per Day | 24.4 percentage of subjects |
| AdVance XP | Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use | 1 Pad per Day | 4.9 percentage of subjects |
| AdVance XP | Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use | 5 or more Pads per Day | 36.6 percentage of subjects |
| AdVance XP | Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use | 2 Pads per Day | 26.8 percentage of subjects |
Primary
Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use
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);
Time frame: 3 Months Post Procedure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AdVance | Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use | 0 Pads per Day | 87.1 percentage of subjects |
| AdVance | Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use | 1 Pad per Day | 9.7 percentage of subjects |
| AdVance | Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use | 2 Pads per Day | 3.2 percentage of subjects |
| AdVance | Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use | 3 Pads per Day | 0 percentage of subjects |
| AdVance | Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use | 4 Pads per Day | 0 percentage of subjects |
| AdVance | Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use | 5 Pads per Day | 0 percentage of subjects |
| AdVance XP | Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use | 4 Pads per Day | 0 percentage of subjects |
| AdVance XP | Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use | 0 Pads per Day | 86.8 percentage of subjects |
| AdVance XP | Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use | 3 Pads per Day | 0 percentage of subjects |
| AdVance XP | Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use | 1 Pad per Day | 10.5 percentage of subjects |
| AdVance XP | Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use | 5 Pads per Day | 0 percentage of subjects |
| AdVance XP | Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use | 2 Pads per Day | 2.6 percentage of subjects |
Primary
Percentage of Subjects With a ≥50% Reduction in Pads Per Day Use
Evaluate the proportion of subjects with a ≥50% reduction in pads per day use
Time frame: 3 Months Post Procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AdVance | Percentage of Subjects With a ≥50% Reduction in Pads Per Day Use | 87.2 percentage of participants |
| AdVance XP | Percentage of Subjects With a ≥50% Reduction in Pads Per Day Use | 97.6 percentage of participants |
Primary
Percentage of Subjects With a ≥50% Reduction in Pads Per Day Use
Evaluate the proportion of subjects with a ≥50% reduction in pads per day use
Time frame: Prospective follow-up to 36 Months Post Procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AdVance | Percentage of Subjects With a ≥50% Reduction in Pads Per Day Use | 69.2 percentage of subjects |
| AdVance XP | Percentage of Subjects With a ≥50% Reduction in Pads Per Day Use | 90.2 percentage of subjects |