Second-generation male sling beneficial at 5-year follow-up

The second-generation AdVance XP male sling system offered good mid-term results for the treatment of post-radical prostatectomy male stress urinary incontinence (SUI), researchers reported at the AUA annual meeting in Chicago.

“Many studies have shown that the AdVance sling is effective and safe in the treatment of post-prostatectomy incontinence,” said first author Jan-Niclas Mumm, a urology intern at Ludwig-Maximilians University Munich in Germany. The AdVance XP, which has been used in Europe for several years and recently became available in the United States, features longer arms and a new anchoring mechanism, as well as a reshaped introducer needle, which Mumm said improves its ease of use.

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The new study was a prospective trial including 115 patients; those with previous urinary incontinence surgery, previous radiotherapy, nocturnal urinary incontinence, and a functional urethra <1 cm in the preoperative repositioning test were excluded from the study. The authors used a strict definition of success for the device: A patient was considered cured if he used no pads and had 0 to 5 grams on a 24-hour pad test; he was considered improved if there was a reduction in urine loss of more than 50% in the 24-hour pad test. All other results were considered failures.

The median age in the trial was 69.0 years. Most men had undergone an open radical prostatectomy (75%), with fewer numbers undergoing robotic radical prostatectomy (14%) or a laparoscopic radical prostatectomy (11%). There was an average time between surgery and sling implantation of 29 months, and the mean urine loss at baseline was 341 g (median, 272.0 g) on the 24-hour pad test.

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Among the 102 patients evaluable at 24 months, 66.7% were cured, 26.5% were improved, and 6.9% failed. At 48 months, among 60 patients, the cured, improved, and failure rates were 71.7%, 15.0%, and 13.3%, respectively. At the 5-year follow-up, 61.1% were cured, 19.4% were improved, and 19.4% failed. The mean urine loss was reduced substantially, to 24.4 grams (p<.001).

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There were no intraoperative or long-term complications in the trial, and there was no erosion or explantation. There were six patients (5.2%) with persistent urinary retention, and dissection of one sling arm was necessary. The investigators slightly altered their surgical approach in response, and later in the trial no such cases occurred.

“The AdVance XP sling shows good and stable effectiveness and low complication rates, even in a follow-up of 5 years,” Mumm said. “Also, our results highlight the importance of adequate preoperative patient selection.”

The study also assessed patients using the International Quality of Life Score (IQOL), the International Consultation on Incontinence Questionnaire short form (ICIQ-UI SF), the visual analogue scale (VAS) for pain, the five-item version of the International Index of Erectile Function (IIEF-5), the International Prostate Symptom Score (IPSS), and the Patient Global Impression of Improvement (PGI-I).

The mean I-QOL and ICIQ-UI SF scores improved significantly with the Advance XP (p<.001 for both) after 5 years of follow-up. The mean VAS was 0.5, suggesting very little pain, and the mean PGI of 1.5 denotes a high satisfaction rate. There were no significant postoperative changes to the IIEF-5 or to the IPSS (p>.05 for both).