|ITEM METADATA RECORD
|Title: ||Prospective multicentre trial of monarc transobturator sling for stress incontinence: 12 month functional data|
|Authors: ||De Ridder, Dirk ×|
Marques Quemadelos, A
Mellier, G #
|Issue Date: ||2005 |
|Publisher: ||Elsevier Science|
|Host Document: ||European urology supplements vol:4 issue:3 pages:17-17|
|Conference: ||EAU date:2005|
|Article number: ||58|
|Abstract: ||INTRODUCTION & OBJECTIVES: To evaluate the efficacy and morbidity of Monarc transobturator sling as treatment for women with stress incontinence. This abstract is a planned
interim report on the functional results at 1 year follow up.
MATERIAL & METHODS: The study was designed as a multicentre prospective non-randomized trial, involving 15 European, Canadian, and Australian centres and was approved by local "IRB or Ethical committees. Only women with proven stress incontinence were included. Post implant evaluation was done at 4-6 weeks, 3, 6, 12 and 24 months. The evaluation consisted of registration of number of pads used per day, a lh pad test, cough test, uroflowmetry and measurement of residual volume and dipstick. Both physician and patients scored the post operative continence. In a subset of patients pre-operative and post-operative multichannel urodynamics were compared. Further
evaluation was done using UDI-6, IIQ-7 questionnaires. Efficacy is expressed as the percentage of patients reaching continence, defined by padtest, coughtest, and patient/physician assessment. Appropriate statistical analysis was done using t-test and Mc Nemar's test.
RESULTS: 148 patients with proven stress incontinence were enrolled from Jan 03 until Feb 04.122 have reached ly follow up and are included in this interim analysis. Patient assessment of continence revealed 83.5% cure rate: 62% completely dry and 21.5 % substantially continent (needing no protection). Some additional protection was needed in 12.4% and 4.1% remained substantially incontinent. Assessment by the physician correlated strongly with these numbers. The post-operative cough test was negative in 89.7%. Pad use on 24h was reduced from 3.5 ±2.2 to 0.6 ±1.3 (p<0.001). Urine loss during a 1 h pad test (n-ll0) was reduced from 112.4 ±83.3 to 9.7 ±29.8 (p<0.001). The UDI-6 showed significant improvement (62.3 ±15.9 to 16.2 ±21.3, p<0.001) as did the IIQ-7 (54.5 ±25.3 to 9.5 ±20, p<0.001). This improvement was stable over tile
12 month period. De novo urgency was seen in 10.6% while 27.6% of patients with pre-operative urge symptoms were relieved of their urgency. Uroflowmetry showed a mean voided volume of 333.8cc ±118.5 with a peak flow rate of 24.9 =10.7ml/sec and a post-void residual of 8.5 ±2hnl.
CONCLUSIONS: 1 year data show that Monarc transobturator sling successfully restores continence in women with SUI. Patient and physician assessed continence rate (completely dry and substantially continent) were 83.5% and 84.4%. UDI-6 and IIQ-7 were significantly improved and showed a stable curve over this 12 month period. Given the I0.6% of patients with de novo urge and the 27.6% of patients who were cured of their pre-operative urge, patients implanted with Monarc are significantly more likely to be cured of urge symptoms than to develop urge symptoms (p<0.01 ).
|Publication status: ||published|
|KU Leuven publication type: ||IMa|
|Appears in Collections:||Urology Section (-)|
× corresponding author|
# (joint) last author|
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