A Post-Market Study of the AMS AdVance™ Male Sling System for the Treatment of Male Stress Urinary Incontinence

Browse trials for

• Urinary Incontinence 1,363
• Enuresis 845
• Urinary Incontinence, Stress 658

Keywords

• Urinary Incontinence, Stress
• Intrinsic sphincter deficiency
• Secondary
• TUR
• TURP
• Radical prostatectomy
• Open prostatectomy
• Post-suprapubic prostatectomy

Urinary Incontinence

1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.

This study's enrollment of 114 is above the median of 66 across 1,011 interventional studies indexed under Urinary Incontinence.

Lead sponsor

Boston Scientific Corporation is the lead sponsor of 517 studies on the registry; 38 are open to participants now.

Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.

Study arms

• Experimental
  AMS AdVance Sling Group

  European Male subjects \>40 years old who were implanted with the AMS AdVance Male Sling to treat Stress Urinary Incontinence.

  Device: American Medical Systems (AMS) AdVance™ Male Sling System

Interventions

• DeviceAmerican Medical Systems (AMS) AdVance™ Male Sling System

  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.

  Also known as: Device: AdVance Male Sling

Primary outcomes

1. 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

2. 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

3. 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

4. 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

Secondary outcomes

1. 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.

   Time frame: 24 months

Baseline characteristics

Individual participant data

Plan to share: Yes — Publications on study data currently in draft by physicians.