Publications by authors named "Flip ter Meulen"

3 Publications

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Treatment of stress urinary incontinence using a copolymer system: impact on quality of life.

BJU Int 2004 Nov;94(7):1040-3

Department of Urology, University Hospital Maastricht, The Netherlands.

Objective: To investigate the effect on quality of life (QoL) of a novel system for treatment of stress urinary incontinence (SUI).

Patients And Methods: In an open, prospective, multicentre study, 42 women not previously treated by invasive therapy and with urodynamically verified SUI received 4 x 1.0 mL or 4 x 0.7 mL of non-animal stabilized hyaluronic acid/dextranomer copolymer injected transurethrally into the urethra via the Implacer device (Zuidex system, Q-Med AB, Uppsala, Sweden). QoL was assessed using the King's Health Questionnaire. The patients' perception of treatment benefit and the number of incontinence episodes/24 h were also investigated.

Results: There were significant improvements over baseline in seven of 10 domains of the King's Health Questionnaire at 3 months, and these improvements were sustained at 1 year. For the change from baseline to 1 year, eight of 10 domains showed a significant positive correlation with the number of incontinence episodes/24 h. In terms of treatment benefit, most of the women perceived an improvement at 1, 3, 6 and 12 months. Of the 18 women requiring re-treatment, most perceived an improvement at 3, 6 and 12 months.

Conclusion: Treatment with the Zuidex system produced significant improvements over a year in both subjective QoL and objective incontinence measures, with a significant positive correlation between them.
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http://dx.doi.org/10.1111/j.1464-410X.2004.05101.xDOI Listing
November 2004

Efficacy and safety of a novel system (NASHA/Dx copolymer using the Implacer device) for treatment of stress urinary incontinence.

Urology 2004 Aug;64(2):276-81

Department of Urology, University Hospital Maastricht, Maastricht, The Netherlands.

Objectives: To investigate the efficacy and safety of non-animal-stabilized hyaluronic acid/dextranomer (NASHA/Dx) copolymer for transurethral injection using a new guiding instrument (the Implacer) for stress urinary incontinence.

Methods: In an open, prospective, multicenter study, 42 invasive therapy-naive female patients with stress urinary incontinence were given 4 x 1.0 mL or 4 x 0.7 mL of NASHA/Dx copolymer using the Implacer. The efficacy parameters, measured at baseline and 1, 3, 6, and 12 months after treatment, included cough-induced leak point pressure, urine leakage by provocation test, number of incontinence episodes in 24 hours, and patient perception of bladder condition, rated on a 6-point scale.

Results: The collected cough-induced leak point pressure data were not judged to be valid and reliable. Statistically significant reductions in median urine leakage were observed (P <0.0001), from 36 g (range 0.0-300) after 20 "jumping jacks" or vigorous coughs at baseline to 5.5 g (range 0.0-98) at 3 months and sustained at 12 months (7.0 g, range 0.0-98). Of the 42 patients, 32 (76%) demonstrated a degree of improvement in urine leakage at 3 and 12 months. The median number of incontinence episodes in 24 hours decreased significantly from 1.9 (range 0.0-24) at baseline to 0.4 (range 0.0-24) at 12 months (P <0.0001). At both 3 and 12 months, 29 patients (69%) had improved by at least one category on the 6-point patient perception scale. Treatment was well tolerated, and no complications were reported with use of the Implacer.

Conclusions: The results of this study indicate that a novel system (NASHA/Dx copolymer insertion using the Implacer) is an effective and well-tolerated treatment for invasive therapy-naive patients with stress urinary incontinence, with improvement sustained for at least 12 months. These encouraging results warrant additional study.
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http://dx.doi.org/10.1016/j.urology.2004.03.017DOI Listing
August 2004

Treatment of stress urinary incontinence: recent developments in the role of urethral injection.

Urol Res 2003 Feb 30;30(6):356-62. Epub 2003 Jan 30.

Department of Urology, University Hospital Maastricht, The Netherlands.

Stress urinary incontinence is prevalent in adult women and has a considerable impact on quality of life. However, it often remains undiagnosed and therefore untreated. Non-invasive treatment is likely to be offered in mild cases and may entail physiotherapy, minimally invasive devices or pharmacotherapy. Surgical intervention is widely considered as the only effective option for more severe cases. These strategies are not suitable for all patients, and urethral injection represents an alternative, minimally invasive procedure. The choice of the bulking agent is the key to the success of this treatment: the most extensively studied are silicone, polytetrafluoroethylene and bovine collagen. However, doubts regarding the safety and efficacy of these materials has led to the development of carbon-coated zirconium beads, calcium hydroxylapatite and dextranomer/hyaluronic acid (Dx/HA) copolymer. Of these, the most clinical experience has been gained with Dx/HA copolymer. Until 2 years ago, urethral injection could only be administered endoscopically. The recent development of devices for 'blind' injection has increased the speed and convenience of urethral injection, removing the need for surgical facilities. Although few data are yet available, it is conceivable that urethral injection administered 'blind' may in future be considered as an option for all patients failing non-invasive treatment.
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http://dx.doi.org/10.1007/s00240-002-0290-1DOI Listing
February 2003