Clinical trial NCT01725984: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Incontinence, Stress
Intrinsic Sphincter Deficiency
Keywords: Male Incontinence
AdVance Male Sling
AdVance XP Male Sling
Male Sling
Lead sponsor: American Medical Systems
Sponsor class: INDUSTRY
First posted: 2012-11-14
Enrollment: 80
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Subjects With a ≥50% Reduction in Pads Per Day Use
timeFrame: 3 Months Post Procedure
measure: Percentage of Subjects Cured, Improved, or Failed Based on Reported Pad Per Day Use
timeFrame: 3 months Post Procedure
measure: Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use
timeFrame: Baseline
measure: Evaluate the 24-hour Pad Weight at the Final Prospective Follow-up Visit
timeFrame: Prospective follow-up to 36 Months Post Procedure
measure: 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.
timeFrame: Baseline to Prospective Follow Up (up to 36 months)
measure: Number of Adverse Events Reported Between Arms
timeFrame: Prospective follow-up to 36 Months Post Procedure
measure: Percentage of Subjects With a ≥50% Reduction in Pads Per Day Use
timeFrame: Prospective follow-up to 36 Months Post Procedure
measure: Percentage of Subjects Cured, Improved, or Failed Based on Reported Pad Per Day Use
timeFrame: Prospective follow-up to 36 Months Post Procedure
measure: Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use
timeFrame: 3 Months Post Procedure
measure: Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use
timeFrame: Prospective follow-up to 36 Months Post Procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Ludwig-Maximilians Universität (LMU)
state: Bavaria
Study officials:
affiliation: Ludwig-Maximilians Universität (LMU)
name: Ricarda Bauer, MD
role: PRINCIPAL_INVESTIGATOR
References: