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An adjustable male sling for treating urinary incontinence after prostatectomy: a phase III multicentre trial.
BJU Int. 2006 Mar; 97(3):533-9.BI

Abstract

OBJECTIVE

To evaluate the efficacy and safety of a new adjustable bulbourethral sling (Argus, Promedon SA, Cordoba, Argentina) in the treatment of male stress urinary incontinence (SUI) after prostate surgery.

PATIENTS AND METHODS

In all, 48 patients with SUI because of prostatic surgery for prostate cancer (39) or benign prostatic hyperplasia (nine) had a new sling implanted in a multicentre trial at six institutions between April 2003 and September 2004. All patients were fully evaluated, including a questionnaire (International Consultation on Incontinence Questionnaire-Short Form, ICIQ-SF, range 0-21), endoscopy, and urodynamic evaluation. The Argus system comprises a 4.2 x 2.6 x 0.9 cm thick silicone foam pad for soft bulbar urethral compression. The pad is attached to the silicone cone columns that, after being passed with needles from the perineum to the abdominal wall, are adjusted with silicone washers to regulate and keep the desired tension against the urethra. The pad and washers are radio-opaque, which allows their position to be assessed during follow-up. The surgical technique was one described previously, with some modifications.

RESULTS

At a mean (range) follow-up of 7.5 (1-17.5) months, 35 (73%) of the 48 patients were dry, five (10%) were improved, and eight (17%) were incontinent, including four (8%) who needed sling adjustment. The mean (range) ICIQ-SF improved from 19.2 (12-21) to 4 (0-21). There were three (6%) urethral perforations during surgery that were resolved by re-passing the needle. The sling was removed in three men (6%) due to erosion and in two (4%) due to infection. Seven (15%) cases of acute urinary retention resolved spontaneously, except for one that needed the sling loosening. No cases of chronic retention were reported. There was perineal discomfort and mild dysuria soon after surgery that resolved spontaneously after a few weeks.

CONCLUSION

This new adjustable male sling safely and effectively controls sphincter incontinence in men after prostate surgery, with an acceptably low complication rate. The early results are encouraging; the Argus is a valid alternative to the artificial urinary sphincter, the standard therapy for this condition.

Authors+Show Affiliations

Urology Department, Hospital Durand, Buenos Aires, Argentina. sromano1@arnet.com.arNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16469021

Citation

Romano, Salomon V., et al. "An Adjustable Male Sling for Treating Urinary Incontinence After Prostatectomy: a Phase III Multicentre Trial." BJU International, vol. 97, no. 3, 2006, pp. 533-9.
Romano SV, Metrebian SE, Vaz F, et al. An adjustable male sling for treating urinary incontinence after prostatectomy: a phase III multicentre trial. BJU Int. 2006;97(3):533-9.
Romano, S. V., Metrebian, S. E., Vaz, F., Muller, V., D'Ancona, C. A., Costa DE Souza, E. A., & Nakamura, F. (2006). An adjustable male sling for treating urinary incontinence after prostatectomy: a phase III multicentre trial. BJU International, 97(3), 533-9.
Romano SV, et al. An Adjustable Male Sling for Treating Urinary Incontinence After Prostatectomy: a Phase III Multicentre Trial. BJU Int. 2006;97(3):533-9. PubMed PMID: 16469021.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - An adjustable male sling for treating urinary incontinence after prostatectomy: a phase III multicentre trial. AU - Romano,Salomon V, AU - Metrebian,Sergio E, AU - Vaz,Fernando, AU - Muller,Valter, AU - D'Ancona,Carlos A, AU - Costa DE Souza,Eugenio A, AU - Nakamura,Fabio, PY - 2006/2/14/pubmed PY - 2006/4/4/medline PY - 2006/2/14/entrez SP - 533 EP - 9 JF - BJU international JO - BJU Int VL - 97 IS - 3 N2 - OBJECTIVE: To evaluate the efficacy and safety of a new adjustable bulbourethral sling (Argus, Promedon SA, Cordoba, Argentina) in the treatment of male stress urinary incontinence (SUI) after prostate surgery. PATIENTS AND METHODS: In all, 48 patients with SUI because of prostatic surgery for prostate cancer (39) or benign prostatic hyperplasia (nine) had a new sling implanted in a multicentre trial at six institutions between April 2003 and September 2004. All patients were fully evaluated, including a questionnaire (International Consultation on Incontinence Questionnaire-Short Form, ICIQ-SF, range 0-21), endoscopy, and urodynamic evaluation. The Argus system comprises a 4.2 x 2.6 x 0.9 cm thick silicone foam pad for soft bulbar urethral compression. The pad is attached to the silicone cone columns that, after being passed with needles from the perineum to the abdominal wall, are adjusted with silicone washers to regulate and keep the desired tension against the urethra. The pad and washers are radio-opaque, which allows their position to be assessed during follow-up. The surgical technique was one described previously, with some modifications. RESULTS: At a mean (range) follow-up of 7.5 (1-17.5) months, 35 (73%) of the 48 patients were dry, five (10%) were improved, and eight (17%) were incontinent, including four (8%) who needed sling adjustment. The mean (range) ICIQ-SF improved from 19.2 (12-21) to 4 (0-21). There were three (6%) urethral perforations during surgery that were resolved by re-passing the needle. The sling was removed in three men (6%) due to erosion and in two (4%) due to infection. Seven (15%) cases of acute urinary retention resolved spontaneously, except for one that needed the sling loosening. No cases of chronic retention were reported. There was perineal discomfort and mild dysuria soon after surgery that resolved spontaneously after a few weeks. CONCLUSION: This new adjustable male sling safely and effectively controls sphincter incontinence in men after prostate surgery, with an acceptably low complication rate. The early results are encouraging; the Argus is a valid alternative to the artificial urinary sphincter, the standard therapy for this condition. SN - 1464-4096 UR - https://www.unboundmedicine.com/medline/citation/16469021/An_adjustable_male_sling_for_treating_urinary_incontinence_after_prostatectomy:_a_phase_III_multicentre_trial_ L2 - https://doi.org/10.1111/j.1464-410X.2006.06002.x DB - PRIME DP - Unbound Medicine ER -