- Email: [email protected]
Re: Is Self-Reported Adherence Associated with Clinical Outcomes in Women Treated with Anticholinergic Medication for Overactive Bladder?
VOIDING FUNCTION, BLADDER PHYSIOLOGY AND PHARMACOLOGY, AND FEMALE UROLOGY
229 230 231 232 233 234 235 236 237 238 239 240 241 242 243 244 245 246 247 248 249 250 251 252 253 254 255 256 257 258 259 260 261 262 263 264 265 266 267 268 269 270 271 272 273 274 275 276 277 278 279 280 281 282 283 284 285
Ultimately 189 participants were randomized to sacral neuromodulation. Of these patients 169 completed the first stage and 142 were categorized as clinical responders, of whom 139 received the stimulator. Of the 192 women randomized to receive botulinum toxin 189 received the complete dose during cystoscopic injection. Baseline urinary incontinence episodes in the neuromodulation group averaged 5.2 per day and in the botulinum toxin group 5.4. Total incontinence episodes were 5.8 and 6.0, respectively. Change in mean daily UUI episodes was 3.25 in the neuromodulation group and 3.89 in the botulinum toxin group. Among those who completed all 6 months of the diaries complete resolution occurred in 2% of the neuromodulation group and 20% of the botulinum toxin group. Greater than 75% reduction occurred in 27% of the sacral neuromodulation group and 50% of the botulinum toxin group. There was no statistically significant difference in the Patient Global Impression of Improvement even in terms of urinary leakage or bladder function between the 2 groups. Patients who received botulinum toxin had greater improvements in the Overactive Bladder Questionnaire Short Form symptom bother as well as the subscales for treatment satisfaction and endorsement. There was no significant difference for quality of life or for the subscales of treatment preference, convenience or adverse effects. Six patients in the neuromodulation group (3%) had their device revised or removed during the 6-month period. In the botulinum toxin group 8% required intermittent self-catheterization at 1 month, 4% at 3 months and 2% at 6 months. The threshold for intermittent catheterization was a post-void residual of more than 300 ml or more than 200 ml with symptoms of incomplete voiding. By 6 months the risk of urinary tract infection was greater in the botulinum toxin group (35%) than in the sacral neuromodulation group (11%). No study is perfect. However, this one is close and objectively reported. The real telling factor, of course, will be what happens to these individuals over time, whether the effects are sustained and the occurrence of any additional adverse effects, including the requirement for repair or removal of the neuromodulation system. The economics as well will be of interest. This is the first article, but not the last one, from this trial. Alan J. Wein, MD, PhD (hon)
Re: Is Self-Reported Adherence Associated with Clinical Outcomes in Women Treated with Anticholinergic Medication for Overactive Bladder? U. U. Andy, L. A. Arya, A. L. Smith, K. J. Propert, H. R. Bogner, K. Colavita and H. S. Harvie Division of Urogynecology, Department of Obstetrics and Gynecology, Division of Urology, Department of Surgery, Department of Biostatistics and Epidemiology, and Department of Family Medicine and Community Health, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania Neurourol Urodyn 2016; 35: 738e742. doi: 10.1002/nau.22798
Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/25995132 Editorial Comment: The conclusion to this article is certainly logical but the reason is not. In a group of 184 women in whom medication adherence and outcome data were available 62.5% were adherent to anticholinergic medication at 8 weeks. Adherence was defined based on the responses to the medication adherence self-report inventory, a 12-item questionnaire of self-reported medication adherence that addresses the amount of medication taken and the timing of the doses. Overall 61.4% of patients reported improvement in their symptoms, reflecting a response of “little better,” “much better” or “very much better” on the Patient Global Impression of Improvement (PGI-I) at 8 weeks compared to baseline. Women who were adherent to the medication were more likely to report improvement in their symptoms compared to women who were not (84% vs 24%). Women in the nonadherent group were more likely report “no change” (77% vs 11%). A greater proportion of nonadherent women described their bladder symptoms as “moderate” or “severe” on the Patient Global Impression of Severity (PGI-S) at 8 weeks (74% vs 44%). The assessments used were the Urinary Distress Inventory, Incontinence Impact Questionnaire, PGI-I and PGI-S. The results are not surprising, but is there agreement on the reason? Adherence may have been responsible for the more favorable clinical results but it is also possible that women who experienced greater improvement were more likely to be adherent.1 From the data one could also get a reasonable idea of what to expect regarding improvement in a population of women with overactive bladder on Dochead: Urological Survey
LIT 5.4.0 DTD JURO14637_proof 16 March 2017 1:17 pm EO:
3
286 287 288 289 290 291 292 293 294 295 296 297 298 299 300 301 302 303 304 305 306 307 308 309 310 311 312 313 314 315 316 317 318 319 320 321 322 323 324 325 326 327 328 329 330 331 332 333 334 335 336 337 338 339 340 341 342
4
343 344 345 346 347 348 349 350 351 352 353 354 355 356 357 358 359 360 361 362 363 364 365 366 367 368 369 370 371 372 373 374 375 376 377 378 379 380 381 382 383 384 385 386 387 388 389 390 391 392 393 394 395 396 397 398 399
VOIDING FUNCTION, BLADDER PHYSIOLOGY AND PHARMACOLOGY, AND FEMALE UROLOGY
antimuscarinic medication. Using the PGI-I, which I think is a very reliable measure, 49% of subjects reported they were much better or very much better after 8 weeks of treatment, with another 35% reporting they were a little better. In the nonadherent group corresponding numbers were 6% and 18%. In the PGI-S metric 66% of patients in the adherent group reported they either were normal or had mild symptoms with another 33% reporting moderate symptoms, whereas in the nonadherent group corresponding numbers were 26% and 61%. Alan J. Wein, MD, PhD (hon) 1. Benner JS, Nichol MB, Rovner ES et al: Patient-reported reasons for discontinuing overactive bladder medication. BJU Int 2010; 105: 1276.
Suggested Reading Veenboer PW and Bosch JL: Long-term adherence to antimuscarinic therapy in everyday practice: a systematic review. J Urol 2014; 191: 1003.
Re: Workforce Analysis of Female Pelvic Medicine and Reconstructive Surgery, 2015 to 2045 T. Brueseke, T. Muffly, W. Rayburn, A. Connolly, M. Nieto, J. De La Cruz and J. Wu Division of Urogynecology and Reconstructive Surgery, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, Department of Obstetrics and Gynecology, Denver Health and Hospital Authority, Denver, Colorado, and Department of Obstetrics and Gynecology, University of New Mexico, Albuquerque, New Mexico Female Pelvic Med Reconstr Surg 2016; 22: 385e389. doi: 10.1097/SPV.0000000000000302
Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/27403757 Editorial Comment: This article, from a primarily gynecologic journal, reports an assessment of how the projected increase in prevalence of pelvic floor disorders will impact the number of patients per subspecialist in female pelvic medicine and reconstructive surgery (FPMRS) between 2015 and 2045. It should be noted that the survey used only a deidentified American Urogynecological Society database to identify the number, age and gender distribution of such specialists. The authors began with a cohort of 1,059 active specialists in 2013, which included 100 urologists. Unfortunately the Society for Urodynamics and Female Urology apparently was not consulted and the number of urologists may well have been underestimated, and so the numbers would have to be adjusted accordingly. But even with an adjustment the numbers are rather startling. The model predicts that 50 new subspecialists in this area would be added to the workforce each year based on the number of Accreditation Council for Graduate Medical Education accredited fellowship positions filled in 2014. The predicted number then would increase to 1,133 to 1,514 with a gender shift from 46% women to 81% women between 2015 and 2045. The number of women with 1 or more pelvic floor disorders is predicted to increase from 31.4 million to 41.9 million between 2015 and 2045. The number of patients per FPMRS subspecialist is projected to range from 27,870 in 2015 to 27,650 in 2045. This includes women with urinary incontinence, prolapse and fecal incontinence. The number of women with 1 or more pelvic floor disorders per FPMRS specialist is projected to drop initially from 27,870 in 2015 to 26,350 per provider in 2025 as additional providers enter the workforce. However, from 2025 to 2040 a decrease in the number of male providers is projected, which results in 28,490 patients per provider in 2040. By 2045 the number of female providers matches the decrease in the number of male providers and the ratio returns to 27,650 patients per provider. Few data exist regarding the ratio of disease prevalence per provider for other subspecialties. There are a few shortcomings to the calculations. The calculation assumes that all subspecialists work full time until retirement and that the number of subspecialists trained per year does not change. Presumably there will be more urology programs that are certified, although I suspect that the additional number will be a single digit number. The article also ignores the fact that urologists in general are well trained in the fundamentals of urinary incontinence in women, arguably less so with respect to prolapse and certainly less so with respect to fecal incontinence. One of the most commonly done surgical procedures by urologists who are not FPMRS certified is correction of urinary Dochead: Urological Survey
LIT 5.4.0 DTD JURO14637_proof 16 March 2017 1:17 pm EO:
400 401 402 403 404 405 406 407 408 409 410 411 412 413 414 415 416 417 418 419 420 421 422 423 424 425 426 427 428 429 430 431 432 433 434 435 436 437 438 439 440 441 442 443 444 445 446 447 448 449 450 451 452 453 454 455 456
229 230 231 232 233 234 235 236 237 238 239 240 241 242 243 244 245 246 247 248 249 250 251 252 253 254 255 256 257 258 259 260 261 262 263 264 265 266 267 268 269 270 271 272 273 274 275 276 277 278 279 280 281 282 283 284 285
Ultimately 189 participants were randomized to sacral neuromodulation. Of these patients 169 completed the first stage and 142 were categorized as clinical responders, of whom 139 received the stimulator. Of the 192 women randomized to receive botulinum toxin 189 received the complete dose during cystoscopic injection. Baseline urinary incontinence episodes in the neuromodulation group averaged 5.2 per day and in the botulinum toxin group 5.4. Total incontinence episodes were 5.8 and 6.0, respectively. Change in mean daily UUI episodes was 3.25 in the neuromodulation group and 3.89 in the botulinum toxin group. Among those who completed all 6 months of the diaries complete resolution occurred in 2% of the neuromodulation group and 20% of the botulinum toxin group. Greater than 75% reduction occurred in 27% of the sacral neuromodulation group and 50% of the botulinum toxin group. There was no statistically significant difference in the Patient Global Impression of Improvement even in terms of urinary leakage or bladder function between the 2 groups. Patients who received botulinum toxin had greater improvements in the Overactive Bladder Questionnaire Short Form symptom bother as well as the subscales for treatment satisfaction and endorsement. There was no significant difference for quality of life or for the subscales of treatment preference, convenience or adverse effects. Six patients in the neuromodulation group (3%) had their device revised or removed during the 6-month period. In the botulinum toxin group 8% required intermittent self-catheterization at 1 month, 4% at 3 months and 2% at 6 months. The threshold for intermittent catheterization was a post-void residual of more than 300 ml or more than 200 ml with symptoms of incomplete voiding. By 6 months the risk of urinary tract infection was greater in the botulinum toxin group (35%) than in the sacral neuromodulation group (11%). No study is perfect. However, this one is close and objectively reported. The real telling factor, of course, will be what happens to these individuals over time, whether the effects are sustained and the occurrence of any additional adverse effects, including the requirement for repair or removal of the neuromodulation system. The economics as well will be of interest. This is the first article, but not the last one, from this trial. Alan J. Wein, MD, PhD (hon)
Re: Is Self-Reported Adherence Associated with Clinical Outcomes in Women Treated with Anticholinergic Medication for Overactive Bladder? U. U. Andy, L. A. Arya, A. L. Smith, K. J. Propert, H. R. Bogner, K. Colavita and H. S. Harvie Division of Urogynecology, Department of Obstetrics and Gynecology, Division of Urology, Department of Surgery, Department of Biostatistics and Epidemiology, and Department of Family Medicine and Community Health, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania Neurourol Urodyn 2016; 35: 738e742. doi: 10.1002/nau.22798
Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/25995132 Editorial Comment: The conclusion to this article is certainly logical but the reason is not. In a group of 184 women in whom medication adherence and outcome data were available 62.5% were adherent to anticholinergic medication at 8 weeks. Adherence was defined based on the responses to the medication adherence self-report inventory, a 12-item questionnaire of self-reported medication adherence that addresses the amount of medication taken and the timing of the doses. Overall 61.4% of patients reported improvement in their symptoms, reflecting a response of “little better,” “much better” or “very much better” on the Patient Global Impression of Improvement (PGI-I) at 8 weeks compared to baseline. Women who were adherent to the medication were more likely to report improvement in their symptoms compared to women who were not (84% vs 24%). Women in the nonadherent group were more likely report “no change” (77% vs 11%). A greater proportion of nonadherent women described their bladder symptoms as “moderate” or “severe” on the Patient Global Impression of Severity (PGI-S) at 8 weeks (74% vs 44%). The assessments used were the Urinary Distress Inventory, Incontinence Impact Questionnaire, PGI-I and PGI-S. The results are not surprising, but is there agreement on the reason? Adherence may have been responsible for the more favorable clinical results but it is also possible that women who experienced greater improvement were more likely to be adherent.1 From the data one could also get a reasonable idea of what to expect regarding improvement in a population of women with overactive bladder on Dochead: Urological Survey
LIT 5.4.0 DTD JURO14637_proof 16 March 2017 1:17 pm EO:
3
286 287 288 289 290 291 292 293 294 295 296 297 298 299 300 301 302 303 304 305 306 307 308 309 310 311 312 313 314 315 316 317 318 319 320 321 322 323 324 325 326 327 328 329 330 331 332 333 334 335 336 337 338 339 340 341 342
4
343 344 345 346 347 348 349 350 351 352 353 354 355 356 357 358 359 360 361 362 363 364 365 366 367 368 369 370 371 372 373 374 375 376 377 378 379 380 381 382 383 384 385 386 387 388 389 390 391 392 393 394 395 396 397 398 399
VOIDING FUNCTION, BLADDER PHYSIOLOGY AND PHARMACOLOGY, AND FEMALE UROLOGY
antimuscarinic medication. Using the PGI-I, which I think is a very reliable measure, 49% of subjects reported they were much better or very much better after 8 weeks of treatment, with another 35% reporting they were a little better. In the nonadherent group corresponding numbers were 6% and 18%. In the PGI-S metric 66% of patients in the adherent group reported they either were normal or had mild symptoms with another 33% reporting moderate symptoms, whereas in the nonadherent group corresponding numbers were 26% and 61%. Alan J. Wein, MD, PhD (hon) 1. Benner JS, Nichol MB, Rovner ES et al: Patient-reported reasons for discontinuing overactive bladder medication. BJU Int 2010; 105: 1276.
Suggested Reading Veenboer PW and Bosch JL: Long-term adherence to antimuscarinic therapy in everyday practice: a systematic review. J Urol 2014; 191: 1003.
Re: Workforce Analysis of Female Pelvic Medicine and Reconstructive Surgery, 2015 to 2045 T. Brueseke, T. Muffly, W. Rayburn, A. Connolly, M. Nieto, J. De La Cruz and J. Wu Division of Urogynecology and Reconstructive Surgery, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, Department of Obstetrics and Gynecology, Denver Health and Hospital Authority, Denver, Colorado, and Department of Obstetrics and Gynecology, University of New Mexico, Albuquerque, New Mexico Female Pelvic Med Reconstr Surg 2016; 22: 385e389. doi: 10.1097/SPV.0000000000000302
Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/27403757 Editorial Comment: This article, from a primarily gynecologic journal, reports an assessment of how the projected increase in prevalence of pelvic floor disorders will impact the number of patients per subspecialist in female pelvic medicine and reconstructive surgery (FPMRS) between 2015 and 2045. It should be noted that the survey used only a deidentified American Urogynecological Society database to identify the number, age and gender distribution of such specialists. The authors began with a cohort of 1,059 active specialists in 2013, which included 100 urologists. Unfortunately the Society for Urodynamics and Female Urology apparently was not consulted and the number of urologists may well have been underestimated, and so the numbers would have to be adjusted accordingly. But even with an adjustment the numbers are rather startling. The model predicts that 50 new subspecialists in this area would be added to the workforce each year based on the number of Accreditation Council for Graduate Medical Education accredited fellowship positions filled in 2014. The predicted number then would increase to 1,133 to 1,514 with a gender shift from 46% women to 81% women between 2015 and 2045. The number of women with 1 or more pelvic floor disorders is predicted to increase from 31.4 million to 41.9 million between 2015 and 2045. The number of patients per FPMRS subspecialist is projected to range from 27,870 in 2015 to 27,650 in 2045. This includes women with urinary incontinence, prolapse and fecal incontinence. The number of women with 1 or more pelvic floor disorders per FPMRS specialist is projected to drop initially from 27,870 in 2015 to 26,350 per provider in 2025 as additional providers enter the workforce. However, from 2025 to 2040 a decrease in the number of male providers is projected, which results in 28,490 patients per provider in 2040. By 2045 the number of female providers matches the decrease in the number of male providers and the ratio returns to 27,650 patients per provider. Few data exist regarding the ratio of disease prevalence per provider for other subspecialties. There are a few shortcomings to the calculations. The calculation assumes that all subspecialists work full time until retirement and that the number of subspecialists trained per year does not change. Presumably there will be more urology programs that are certified, although I suspect that the additional number will be a single digit number. The article also ignores the fact that urologists in general are well trained in the fundamentals of urinary incontinence in women, arguably less so with respect to prolapse and certainly less so with respect to fecal incontinence. One of the most commonly done surgical procedures by urologists who are not FPMRS certified is correction of urinary Dochead: Urological Survey
LIT 5.4.0 DTD JURO14637_proof 16 March 2017 1:17 pm EO:
400 401 402 403 404 405 406 407 408 409 410 411 412 413 414 415 416 417 418 419 420 421 422 423 424 425 426 427 428 429 430 431 432 433 434 435 436 437 438 439 440 441 442 443 444 445 446 447 448 449 450 451 452 453 454 455 456