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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AdVance | Subjects previously implanted with the AdVance Male Sling | ||
| AdVance XP | Subjects previously implanted with the AdVance XP male sling |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 Months Post Procedure |
| 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 | 3 months Post Procedure |
| 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); | Baseline |
| 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. | Prospective follow-up to 36 Months Post Procedure |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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 at one institution in Munich, Germany.
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| Name | Affiliation | Role |
|---|---|---|
| Ricarda Bauer, MD | Ludwig-Maximilians Universität (LMU) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ludwig-Maximilians Universität (LMU) | Munich | Bavaria | 81377 | Germany |
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140 subjects were screened for inclusion into the study. 80 total subjects met all inclusion and none of the exclusion criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | AdVance | Subjects previously implanted with the AdVance Male Sling |
| FG001 | AdVance XP | Subjects previously implanted with the AdVance XP male sling |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Baseline to Prospective Follow Up (up to 36 months) |
| 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 | Prospective follow-up to 36 Months Post Procedure |
| 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 | Prospective follow-up to 36 Months Post Procedure |
| 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 | Prospective follow-up to 36 Months Post Procedure |
| 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); | 3 Months Post Procedure |
| 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); | Prospective follow-up to 36 Months Post Procedure |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | AdVance | Subjects previously implanted with the AdVance Male Sling |
| BG001 | AdVance XP | Subjects previously implanted with the AdVance XP male sling |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Number | percentage of participants | 3 Months Post Procedure |
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| 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 | Posted | Number | percentage of subjects | 3 months Post Procedure |
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| 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); | Posted | Number | percentage of subjects | Baseline |
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| 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. | Posted | Number | percentage of subjects | Prospective follow-up to 36 Months Post Procedure |
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| 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. | Posted | Mean | Standard Deviation | Score on a scale | Baseline to Prospective Follow Up (up to 36 months) |
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| 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 | Posted | Number | Adverse Events | Prospective follow-up to 36 Months Post Procedure |
|
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| 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 | Posted | Number | percentage of subjects | Prospective follow-up to 36 Months Post Procedure |
|
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| 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 | Posted | Number | percentage of subjects | Prospective follow-up to 36 Months Post Procedure |
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| 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); | Posted | Number | percentage of subjects | 3 Months Post Procedure |
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| 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); | Posted | Number | percentage of subjects | Prospective follow-up to 36 Months Post Procedure |
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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).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AdVance | Subjects implanted with the AdVance Male Sling | 2 | 39 | 6 | 39 | ||
| EG001 | AdVance XP | Subjects implanted with the AdVance XP Male Sling | 3 | 41 | 7 | 41 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Infections and infestations | Non-systematic Assessment |
| ||
| Pain/Discomfort | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Incontinence De Novo (Urge) | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Urinary Retention | Renal and urinary disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Elevated Post-Void Residual (PVR) | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Superficial Wound Infection | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Urinary Incontinence- De Novo (Stress) | Renal and urinary disorders | Non-systematic Assessment |
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| Urinary Incontinence- De Novo (Urge) | Renal and urinary disorders | Non-systematic Assessment |
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| Urinary Incontinence- Worsening Urge | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Urinary Tract Infection | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Urinary Urgency | Renal and urinary disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ricarda Bauer | Ludwig Maximilian Universität | +49 89 7095 | Ricarda.Bauer@med.uni-muenchen.de |
| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Male |
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