A prospective, multi-center study of the AdVance Male Sling for Stress Urinary Incontinence. The purpose of this study is to obtain surgical technique data for use in physician education and training and to collect early clinical outcomes data for future publication. This study is not designed to statistically demonstrate safety and efficacy of the device.
A prospective, multi-center study conducted under a common implant and follow-up protocol. The study will collect pre-operative urologic testing, medical history and subject quality of life (Incontinence Quality of Life Questionaire). Intra-operative procedural data will be collected. Pad weight and incontinence severity rating (using the ICIQ survey) will be used to characterize continence status. Post-operative complications, urologic testing, and subject quality of life will be collected at six weeks and three, six, 12, and 24 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
114
The AMS AdVance™ Male Sling System was developed to treat urinary stress incontinence in men resulting from intrinsic sphincter deficiency (ISD). The AdVance™ Male Sling System procedure is minimally invasive and consists of using two single-use needle passers and passing them through two small incisions over the obturator foramen. The needles are pushed in an arc through the tissue and exited at a perineal incision. Once the passers are through the perineal incision, the Sling System mesh arms are attached to the needles which are then pulled back through the needle track to their points of origin over the obturator foramen. The Sling System is subsequently tensioned and all incisions are closed.
Universitaire Ziekenhuisen Leuven
Leuven, Belgium
Clinique Jules Verne
Nantes, Cedex 3, France
Hopital Edouard Herriot
Lyon, France
Change in 1-hour Pad Weight Test From Baseline to 24 Month Follow-up
1 hour pad weight tests were conducted at baseline at all successive follow-up visits. Baseline scores were compared to last visit follow-up at 24 months.
Time frame: 24 months
Change in 24-hour Pad Weight Test From Baseline to 24 Month Follow-up
24 hour pad weight tests were conducted at baseline at all successive follow-up visits. Baseline scores were compared to last visit follow-up at 24 months.
Time frame: 24 months
Percentage of Subjects in Each Range of Pads Per Day Use
Evaluate the proportion of subjects using the following categories of pads per day from baseline to the final 24 month visit follow up 0 to 1 pads per day; 2 -3 pads per day; 4-5 pads per day; 6-7 pads per day; 8-9 pads per day; 10 or greater pads per day
Time frame: Baseline
Percentage of Subjects in Each Range of Pads Per Day Use
Evaluate the proportion of subjects using the following categories of pads per day from baseline to the final 24 month visit follow up 0 to 1 pads per day; 2 -3 pads per day; 4-5 pads per day; 6-7 pads per day; 8-9 pads per day; 10 or greater pads per day
Time frame: 24 months
To Evaluate Patient Quality of Life
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 0-21.
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Time frame: 24 months