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THREE-DIMENSIONAL TRANSURETHRAL ULTRASOUND: MEASUREMENT OF DYNAMIC ACTIVITY OF RHABDOSPHINCTER AND URETHRA IN WOMEN
81
82
EFFECTS OF MAGNETIC STIMULATION IN THE TREATMENT OF PELVIC FLOOR DYSFUNCTION
THREE-DIMENSIONAL TRANSURETHRAL ULTRASOUND: MEASUREMENT OF DYNAMIC ACTIVITY OF RHABDOSPHINCTER AND URETHRA IN WOMEN
Voorham - Van der Zalm P.J., Pelger R.C.M., Stiggelbout A.M., Elzevier H.W., Lycklama A., Nijeholt G.A.B. Leiden University Medical Centre, Urology J-3-p, Leiden, The Netherlands INTRODUCTION & OBJECTIVES: Pelvic floor dysfunction is primarily treated pharmacologically or by physiotherapy. Electrical stimulation has been reported to be an effective treatment. Several techniques of electrical stimulation are available. Extracorporeal magnetic innervation therapy (ExMI) is a more recent technique. This study was designed to correlate the clinical results of this treatment with functional changes in pelvic floor musculature. MATERIAL & METHODS: Seventy four patients with urge incontinence, urgency/ frequency, stress incontinence, mixed incontinence and defecation problems were included in a prospective study, using the Neocontrol electromagnetic chair (Neotonus Inc). Biofeedback registration of the pelvic floor with a vaginal or anal probe, avoiding diary, a pad-test, Kings Health Questionnaire (KHQ, 1993), and a Visual Analogue Scale (VAS), as well as urodynamics were completed at baseline and at the end of the study. Based on previous studies, induction of bladder inhibition is most effective when using a frequency of 10 Hz. The optimal electrical parameter for urethral closure has been proven to be 50 Hz .The results were analysed statistically using the Wilcoxon signed rank tests for paired data, the independent paired T-test (Mann Whitney) The One-Sample Kolmogorov-Smirnov Test evaluated normality of data.
Mitterberger M.1, Pinggera G.M.1, Klauser A.2, Frauscher F.2, Bartsch G.1, Strasser H.1 1 Medical University Innsbruck, Urology, Innsbruck, Austria, 2Medical University Innsbruck, Radiology, Innsbruck, Austria
INTRODUCTION & OBJECTIVES: The goal of the present study was to assess the dynamic changes of the urethra in response to contractions of the rhabdosphincter in females with and without urinary stress incontinence. MATERIAL & METHODS: In 33 female patients with clinically proven stress urinary incontinence and in 6 continent females transurethral ultrasound was performed using special intraurethral ultrasound probes (B&K, Denmark; Hitachi, Japan). The ultrasound probes were mounted on a mechanically driven puller system and pulled back slowly with a speed of 1 mm/sec. 3-D reconstructions were calculated using specialized software packages. Contractility of the rhabdosphincter was assessed by measuring the distance between the inner aspects of the rhabdosphincter and the ultrasound transducer during voluntary muscle contraction. Changes in length and diameter of the urethra and the rhabdosphincter in response to voluntary contractions of the rhabdosphincter were also measured.
RESULTS: The mean age of our patients was 54 years (range 22-90). In the group as a whole, comparison of pre- and post treatment data on voiding diary, pad test, KHQ, VAS score, biofeedback registration and urodynamics showed no statistical significant difference (p>0.05) . Also within the sub groups (stress incontinence, urge incontinence, urgency/frequency, defecation problems, over/under active pelvic floor, age < /> 50 years, previous treatments y/n) separately, comparison on pre- and post treatment data indicated no significant difference in all classified groups. Furthermore stratification was applied on the total patient group, related to pre treatment rest tone of the pelvic floor (>1-2<μV, the basal amplitude registered on EMG). The only significance was seen in the KHQ domain “role limitations” (p < 0,05).
RESULTS: Transurethralultrasound and subsequent 3D-reconstruction were successfully performed in all patients. It could be shown that during voluntary contraction of the rhabdosphincter the urethra was compressed. The cranio-caudal length of the urethra as well as the rhabdosphincter was substantially increased in continent patients (up to 2 mm) in response to compression of the urethra. In patients with stress urinary incontinence a statistically significantly reduced contractility of the rhabdosphincter was observed compared to continent females. Increase of urethral length during contraction of the rhabdosphincter was statistically significantly lower in these patients. Furthermore, in patients with stress urinary incontinence atrophies of the rhabdosphincter could be seen.
CONCLUSIONS: ExMI seems to add no changes in both clinical, urodynamics and pelvic floor function parameters in our patient population. We need more tools to evaluate the mode of action of electro stimulation. In our opinion “the chair” is suitable to train awareness of the location of the pelvic floor musculature but the need for active pelvic floor muscle exercises remains.
CONCLUSIONS: Investigation of the female urethra with transurethral ultrasound and 3-D reconstruction proved to be a simple and easy procedure which provided excellent anatomic and physiologic information about the urethra and the rhabdosphincter. Contraction of the rhabdosphincter not only compresses the urethra but also increases the cranio-caudal length of the urethra.
A CALL FOR A SEVERITY CLASSIFICATION IN INCONTINENCE – INSIGHTS FROM THE PURE STUDY
83
84
URINARY
THE USE OF SPIRAL MDCT (MULTIDETECTOR COMPUTED TOMOGRAPHY) SCAN IN PROACT™ (ADJUSTABLE CONTINENCE THERAPY) IMPLANT FAILURES
Monz B.1, Chartier - Kastler E.2, Wagg A.3, Samsioe G.4, Espuna Pons M.5, Hampel C.6, Quail D.7, Chinn C.8, Hunskaar S.9 1
Boehringer Ingelheim International, Health Economics & Outcomes Research, Ingelheim, Germany, 2Curie University, Urology Department, Paris, France, 3University College London Hospitals, Department of Geriatric Medicine, London, United Kingdom, 4University Hospital, Department of Obstetrics & Gynaecology, Lund, Sweden, 5University Hospital, Gynaecology Department, Barcelona, Spain, 6University Hospital, Urology Department, Mainz, Germany, 7 Eli Lilly and Company Limited, Statistics Department, Surrey, United Kingdom, 8Eli Lilly and Company Limited, European Health Outcomes Research, Surrey, United Kingdom, 9University of Bergen, Department of Public Health and Primary Care, Bergen, Norway INTRODUCTION & OBJECTIVES: To investigate the association between patient characteristics and disease-specific quality of life (QOL) as well as the degree of bother in female urinary incontinence (UI). MATERIAL & METHODS: PURE (Prospective Urinary Incontinence Research) was a 6month observational study with 1055 physicians from 14 European countries enrolling 9,487 women (of whom 9434 could be included in the analyses) seeking treatment for their UI during the normal course of care. QOL was assessed at the enrolment visit using the urinary Incontinencespecific Quality of Life questionnaire (I-QOL). A single item instrument was used to measure the degree to which women found their symptoms to be bothersome, on six levels from “not at all” to “extremely”. UI severity was assessed using the Sandvik index resulting in four severity levels. UI was categorized into stress (SUI), mixed (MUI) and urge (UUI) urinary incontinence by S/UIQ, a two item questionnaire to qualify and quantify leakage episodes. Multivariate linear (I-QOL) and logistic (bother) regressions were performed to identify variables predictive of the degree of patient-reported UI impact. Responses on bother were collapsed into two groups and the odds ratio (OR) of being “moderate to extremely” bothered was calculated for each predictor. RESULTS: Mean total I-QOL scores were significantly and independently associated with UI severity, nocturia, age, UI subtype, number of selected concomitant medical conditions, length of suffering from UI symptoms before contacting a doctor, smoking status, and use of UI medication (listed in order of decreasing importance). After adjusting for all above mentioned covariates and additionally for country, the total I-QOL scores for SUI, MUI and UUI were 62.7 (symptom severity slight 77.8 to very severe 49.3), 53.8 (68.9, 40.4), and 60.1 (75.3, 46.7) respectively. The same variables identified for I-QOL were also independently associated with the degree of bother with the exception of smoking status and use of UI medication, and the addition of educational level and BMI. Again, severity was the most important predictor with an adjusted OR of 2.80 (95% CI: 2.58; 3.03) for any increase in one severity grade in the four level scale. CONCLUSIONS: UI severity was the single most important predictor of disease-specific QOL and bother in this large population of females seeking treatment for UI. This is consistent with population-based studies that report UI severity to be an important predictor of treatment seeking. Including severity stratification into existing guidelines for the management of women with UI may help identify those with the highest burden.
Giammò A.1, Bodo G.1, Castellano S.2, Bertapelle P.1, Borrè A.2, Carone R.1 1
ASO CTO-CRF-M. Adelaide, UOA Neuro-Urologia, Turin, Italy, 2ASO CTO-CRF-M. Adelaide, SOC Radiologia Diagnostica, Turin, Italy INTRODUCTION & OBJECTIVES: The use of the Pro-ACT™ device was introduced in 1999 for the treatment of post-prostatectomy incontinence. The Pro-ACT™-System is made up of two balloons implanted close to the urethra through a perineal approach. The volume of the balloons can be adjusted after implantation through a subcutaneous port in the scrotum. Once the device has been re-filled with non ionic contrast medium, postoperatively, a significant clinical improvement may be achieved due to the “bulking effect”. The aim of this study was to evaluate the location of Pro-ACT™ devices in implant failures with the aid of the Spiral MDCT scan. MATERIAL & METHODS: A total of eighteen consecutive implanted patients were evaluated postoperatively using pelvic MDCT scan. A 10 Ch Nelaton catheter was used to better evaluate the urethra and, in 4 cases, to fill the bladder with non-ionic contrast medium (60 ml, 400 mgI/ml). At clinical follow-up 11/18 patients (61%) were dry or showed a significant clinical improvement and 7/18 (39%) had not improved even though the balloons had been re-filled. RESULTS: MDTC scan showed the location of Pro-ACT™ devices compared to the urethra, the bladder neck or prostate apex, pubis and pelvis. The Pro-ACT™ devices were over the urogenital diaphragm, close to the urethral wall, in 64% of “cured” (dry or improved) patients. Whilst, in the other 36%, at least one of the devices was incorrectly positioned, so that only one balloon was able to create the required bulking effect. Indeed, it was observed that all the “nonimproved” patients had devices far from the urethra. Moreover, they were dislocated in the superficial perineum in 86% of cases. The scout-view was not able to diagnose mal-positioning in all these cases and only MDCT scan was able to demonstrate the level of dislocation. CONCLUSIONS: To the best of our knowledge, to date the post-operative evaluation of the Pro-ACT™ devices has relied on pelvis plain-film, that demonstrate deflating balloons and/ or gross dislocations. If plain-film results were unremarkable, the devices were progressively refilled until the maximum volume allowed (8 ml), in an effort to arrive at continence. As the early post-operative plain-film evaluation of patients showing no signs of improvement was limited, it was decided to evaluate these patients by MDCT scan, so as to better demonstrate any incorrect positioning of the devices. In some cases it was seen that further filling of one or both balloons was necessary, whilst in others, a new implant, either mono or bilateral, was required. The CT data obtained in this study demonstrates that, when Pro-ACT™ devices fail, this is due to the lack of the bulking effect, as the balloon/s is/are too far from the urethra wall. MDCT scan evaluation is well accepted by patients and should be considered when, after two refills, there is no improvement, so as to be able to have an early demonstration of the incorrect position of the devices and thus avoid useless refilling and patient discomfort.
Eur Urol Suppl 2006;5(2):43
82
EFFECTS OF MAGNETIC STIMULATION IN THE TREATMENT OF PELVIC FLOOR DYSFUNCTION
THREE-DIMENSIONAL TRANSURETHRAL ULTRASOUND: MEASUREMENT OF DYNAMIC ACTIVITY OF RHABDOSPHINCTER AND URETHRA IN WOMEN
Voorham - Van der Zalm P.J., Pelger R.C.M., Stiggelbout A.M., Elzevier H.W., Lycklama A., Nijeholt G.A.B. Leiden University Medical Centre, Urology J-3-p, Leiden, The Netherlands INTRODUCTION & OBJECTIVES: Pelvic floor dysfunction is primarily treated pharmacologically or by physiotherapy. Electrical stimulation has been reported to be an effective treatment. Several techniques of electrical stimulation are available. Extracorporeal magnetic innervation therapy (ExMI) is a more recent technique. This study was designed to correlate the clinical results of this treatment with functional changes in pelvic floor musculature. MATERIAL & METHODS: Seventy four patients with urge incontinence, urgency/ frequency, stress incontinence, mixed incontinence and defecation problems were included in a prospective study, using the Neocontrol electromagnetic chair (Neotonus Inc). Biofeedback registration of the pelvic floor with a vaginal or anal probe, avoiding diary, a pad-test, Kings Health Questionnaire (KHQ, 1993), and a Visual Analogue Scale (VAS), as well as urodynamics were completed at baseline and at the end of the study. Based on previous studies, induction of bladder inhibition is most effective when using a frequency of 10 Hz. The optimal electrical parameter for urethral closure has been proven to be 50 Hz .The results were analysed statistically using the Wilcoxon signed rank tests for paired data, the independent paired T-test (Mann Whitney) The One-Sample Kolmogorov-Smirnov Test evaluated normality of data.
Mitterberger M.1, Pinggera G.M.1, Klauser A.2, Frauscher F.2, Bartsch G.1, Strasser H.1 1 Medical University Innsbruck, Urology, Innsbruck, Austria, 2Medical University Innsbruck, Radiology, Innsbruck, Austria
INTRODUCTION & OBJECTIVES: The goal of the present study was to assess the dynamic changes of the urethra in response to contractions of the rhabdosphincter in females with and without urinary stress incontinence. MATERIAL & METHODS: In 33 female patients with clinically proven stress urinary incontinence and in 6 continent females transurethral ultrasound was performed using special intraurethral ultrasound probes (B&K, Denmark; Hitachi, Japan). The ultrasound probes were mounted on a mechanically driven puller system and pulled back slowly with a speed of 1 mm/sec. 3-D reconstructions were calculated using specialized software packages. Contractility of the rhabdosphincter was assessed by measuring the distance between the inner aspects of the rhabdosphincter and the ultrasound transducer during voluntary muscle contraction. Changes in length and diameter of the urethra and the rhabdosphincter in response to voluntary contractions of the rhabdosphincter were also measured.
RESULTS: The mean age of our patients was 54 years (range 22-90). In the group as a whole, comparison of pre- and post treatment data on voiding diary, pad test, KHQ, VAS score, biofeedback registration and urodynamics showed no statistical significant difference (p>0.05) . Also within the sub groups (stress incontinence, urge incontinence, urgency/frequency, defecation problems, over/under active pelvic floor, age < /> 50 years, previous treatments y/n) separately, comparison on pre- and post treatment data indicated no significant difference in all classified groups. Furthermore stratification was applied on the total patient group, related to pre treatment rest tone of the pelvic floor (>1-2<μV, the basal amplitude registered on EMG). The only significance was seen in the KHQ domain “role limitations” (p < 0,05).
RESULTS: Transurethralultrasound and subsequent 3D-reconstruction were successfully performed in all patients. It could be shown that during voluntary contraction of the rhabdosphincter the urethra was compressed. The cranio-caudal length of the urethra as well as the rhabdosphincter was substantially increased in continent patients (up to 2 mm) in response to compression of the urethra. In patients with stress urinary incontinence a statistically significantly reduced contractility of the rhabdosphincter was observed compared to continent females. Increase of urethral length during contraction of the rhabdosphincter was statistically significantly lower in these patients. Furthermore, in patients with stress urinary incontinence atrophies of the rhabdosphincter could be seen.
CONCLUSIONS: ExMI seems to add no changes in both clinical, urodynamics and pelvic floor function parameters in our patient population. We need more tools to evaluate the mode of action of electro stimulation. In our opinion “the chair” is suitable to train awareness of the location of the pelvic floor musculature but the need for active pelvic floor muscle exercises remains.
CONCLUSIONS: Investigation of the female urethra with transurethral ultrasound and 3-D reconstruction proved to be a simple and easy procedure which provided excellent anatomic and physiologic information about the urethra and the rhabdosphincter. Contraction of the rhabdosphincter not only compresses the urethra but also increases the cranio-caudal length of the urethra.
A CALL FOR A SEVERITY CLASSIFICATION IN INCONTINENCE – INSIGHTS FROM THE PURE STUDY
83
84
URINARY
THE USE OF SPIRAL MDCT (MULTIDETECTOR COMPUTED TOMOGRAPHY) SCAN IN PROACT™ (ADJUSTABLE CONTINENCE THERAPY) IMPLANT FAILURES
Monz B.1, Chartier - Kastler E.2, Wagg A.3, Samsioe G.4, Espuna Pons M.5, Hampel C.6, Quail D.7, Chinn C.8, Hunskaar S.9 1
Boehringer Ingelheim International, Health Economics & Outcomes Research, Ingelheim, Germany, 2Curie University, Urology Department, Paris, France, 3University College London Hospitals, Department of Geriatric Medicine, London, United Kingdom, 4University Hospital, Department of Obstetrics & Gynaecology, Lund, Sweden, 5University Hospital, Gynaecology Department, Barcelona, Spain, 6University Hospital, Urology Department, Mainz, Germany, 7 Eli Lilly and Company Limited, Statistics Department, Surrey, United Kingdom, 8Eli Lilly and Company Limited, European Health Outcomes Research, Surrey, United Kingdom, 9University of Bergen, Department of Public Health and Primary Care, Bergen, Norway INTRODUCTION & OBJECTIVES: To investigate the association between patient characteristics and disease-specific quality of life (QOL) as well as the degree of bother in female urinary incontinence (UI). MATERIAL & METHODS: PURE (Prospective Urinary Incontinence Research) was a 6month observational study with 1055 physicians from 14 European countries enrolling 9,487 women (of whom 9434 could be included in the analyses) seeking treatment for their UI during the normal course of care. QOL was assessed at the enrolment visit using the urinary Incontinencespecific Quality of Life questionnaire (I-QOL). A single item instrument was used to measure the degree to which women found their symptoms to be bothersome, on six levels from “not at all” to “extremely”. UI severity was assessed using the Sandvik index resulting in four severity levels. UI was categorized into stress (SUI), mixed (MUI) and urge (UUI) urinary incontinence by S/UIQ, a two item questionnaire to qualify and quantify leakage episodes. Multivariate linear (I-QOL) and logistic (bother) regressions were performed to identify variables predictive of the degree of patient-reported UI impact. Responses on bother were collapsed into two groups and the odds ratio (OR) of being “moderate to extremely” bothered was calculated for each predictor. RESULTS: Mean total I-QOL scores were significantly and independently associated with UI severity, nocturia, age, UI subtype, number of selected concomitant medical conditions, length of suffering from UI symptoms before contacting a doctor, smoking status, and use of UI medication (listed in order of decreasing importance). After adjusting for all above mentioned covariates and additionally for country, the total I-QOL scores for SUI, MUI and UUI were 62.7 (symptom severity slight 77.8 to very severe 49.3), 53.8 (68.9, 40.4), and 60.1 (75.3, 46.7) respectively. The same variables identified for I-QOL were also independently associated with the degree of bother with the exception of smoking status and use of UI medication, and the addition of educational level and BMI. Again, severity was the most important predictor with an adjusted OR of 2.80 (95% CI: 2.58; 3.03) for any increase in one severity grade in the four level scale. CONCLUSIONS: UI severity was the single most important predictor of disease-specific QOL and bother in this large population of females seeking treatment for UI. This is consistent with population-based studies that report UI severity to be an important predictor of treatment seeking. Including severity stratification into existing guidelines for the management of women with UI may help identify those with the highest burden.
Giammò A.1, Bodo G.1, Castellano S.2, Bertapelle P.1, Borrè A.2, Carone R.1 1
ASO CTO-CRF-M. Adelaide, UOA Neuro-Urologia, Turin, Italy, 2ASO CTO-CRF-M. Adelaide, SOC Radiologia Diagnostica, Turin, Italy INTRODUCTION & OBJECTIVES: The use of the Pro-ACT™ device was introduced in 1999 for the treatment of post-prostatectomy incontinence. The Pro-ACT™-System is made up of two balloons implanted close to the urethra through a perineal approach. The volume of the balloons can be adjusted after implantation through a subcutaneous port in the scrotum. Once the device has been re-filled with non ionic contrast medium, postoperatively, a significant clinical improvement may be achieved due to the “bulking effect”. The aim of this study was to evaluate the location of Pro-ACT™ devices in implant failures with the aid of the Spiral MDCT scan. MATERIAL & METHODS: A total of eighteen consecutive implanted patients were evaluated postoperatively using pelvic MDCT scan. A 10 Ch Nelaton catheter was used to better evaluate the urethra and, in 4 cases, to fill the bladder with non-ionic contrast medium (60 ml, 400 mgI/ml). At clinical follow-up 11/18 patients (61%) were dry or showed a significant clinical improvement and 7/18 (39%) had not improved even though the balloons had been re-filled. RESULTS: MDTC scan showed the location of Pro-ACT™ devices compared to the urethra, the bladder neck or prostate apex, pubis and pelvis. The Pro-ACT™ devices were over the urogenital diaphragm, close to the urethral wall, in 64% of “cured” (dry or improved) patients. Whilst, in the other 36%, at least one of the devices was incorrectly positioned, so that only one balloon was able to create the required bulking effect. Indeed, it was observed that all the “nonimproved” patients had devices far from the urethra. Moreover, they were dislocated in the superficial perineum in 86% of cases. The scout-view was not able to diagnose mal-positioning in all these cases and only MDCT scan was able to demonstrate the level of dislocation. CONCLUSIONS: To the best of our knowledge, to date the post-operative evaluation of the Pro-ACT™ devices has relied on pelvis plain-film, that demonstrate deflating balloons and/ or gross dislocations. If plain-film results were unremarkable, the devices were progressively refilled until the maximum volume allowed (8 ml), in an effort to arrive at continence. As the early post-operative plain-film evaluation of patients showing no signs of improvement was limited, it was decided to evaluate these patients by MDCT scan, so as to better demonstrate any incorrect positioning of the devices. In some cases it was seen that further filling of one or both balloons was necessary, whilst in others, a new implant, either mono or bilateral, was required. The CT data obtained in this study demonstrates that, when Pro-ACT™ devices fail, this is due to the lack of the bulking effect, as the balloon/s is/are too far from the urethra wall. MDCT scan evaluation is well accepted by patients and should be considered when, after two refills, there is no improvement, so as to be able to have an early demonstration of the incorrect position of the devices and thus avoid useless refilling and patient discomfort.
Eur Urol Suppl 2006;5(2):43