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I-Stop TOMS Transobturator Male Sling, a Minimally Invasive Treatment for Post-prostatectomy Incontinence: Continence Improvement and Tolerability - 06/02/12

Doi : 10.1016/j.urology.2011.08.078 
Philippe Grise a, , Renaud Vautherin b, Bertin Njinou-Ngninkeu c, Ghislain Bochereau d, Jean Lienhart b, Christian Saussine e

HOMme INContinence Study Group

  A complete list of the HOMme INContinence Study Group can be found in the Appendix.

a Department of Urology, Rouen University Hospital, Rouen, France 
b Department of Urology, Trenel Clinic, Sainte-Colombe, France 
c Ormeaux Clinic, Le Havre, France 
d Saint Augustin Clinic, Nantes, France 
e Department of Urology, Strasbourg University Hospital, Strasbourg, France 

Reprint requests: Philippe Grise, M.D., Department of Urology, Rouen University Hospital, 1 Rue de Germont, 76038 Rouen cedex, France

Résumé

Objective

To prospectively evaluate the efficacy and tolerability of the I-STOP TOMS transobturator male sling in patients with post-prostatectomy stress urinary incontinence. Minimally invasive techniques, such as slings, are becoming the standard of care for mild to moderate post-prostatectomy incontinence.

Methods

From March 2007 to June 2009, 122 patients with post-prostatectomy stress urinary incontinence were treated with the I-STOP TOMS sling and followed up for 1 year in the Phase IV HOMme INContinence trial. The preoperative and postoperative evaluation included daily pad use, pad test, questionnaires evaluating urinary function and bother (University of California, Los Angeles, Prostate Cancer Index – urinary function short form, and International Consultation on Incontinence Modular Questionnaire – urinary incontinence short form) and uroflowmetry, including the post-void residual urine volume. Patient satisfaction and perineal pain were also assessed.

Results

A total of 103 patients were followed up for 12 months. The surgical procedure was considered easy to perform. The mean daily pad use decreased significantly from 2.4 to 0.6 at 12 months of follow-up; 87.0% of the patients reported improved continence (59.4% completely dry, 20.3% 1 pad/d, 7.3% >1 pad/d), and 13.0% reported no improvement. All quality-of-life scores (University of California, Los Angeles, Prostate Cancer Index – urinary function short form, and International Consultation on Incontinence Modular Questionnaire – urinary incontinence short form) improved significantly after sling implantation. Treatment satisfaction was >90%. The post-void residual urine volume did not increase substantially, and acute urinary retention did not occur. The perineal pain scores were very low at follow-up. Wound infection was seen in 2 patients at the 1-month follow-up visit.

Conclusion

The I-STOP TOMS is a good treatment option for patients with post-prostatectomy stress urinary incontinence. With follow-up ≤12 months, most patients were continent or had improved continence. The intervention was well tolerated, with few infections.

Le texte complet de cet article est disponible en PDF.

Plan


 Financial Support: CL Medical provided an unconditional grant to support the writing of our report.
 Financial Disclosure: P. Grise is an investigator for Ipsen, Medtronic, and CL Medical; and C. Saussine is an investigator for CL Medical and a consultant for Allergan, AMS, CL Medical, Coloplast, GSK, and Ipsen.


© 2012  Elsevier Inc. Tous droits réservés.
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Vol 79 - N° 2

P. 458-463 - février 2012 Retour au numéro
Article précédent Article précédent
  • Risk Factors and Quality of Life for Post-prostatectomy Vesicourethral Anastomotic Stenoses
  • Rou Wang, David P. Wood, Brent K. Hollenbeck, Amy Y. Li, Chang He, James E. Montie, Jerilyn M. Latini
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