Original Paper
Urologia
Received: September 8, 2014 Accepted after revision: November 24, 2014 Published online: January 31, 2015
Urol Int 2015;95:86–91 DOI: 10.1159/000370163
Internationalis
Can We State Stable Bladder? How Many Repetitions Should We Do for an Appropriate Demonstration of Involuntary Detrusor Contraction? Paulo Rodrigues a, b Flávio Hering a, b Eli Cieli a, b Marcio D’Imperio a João Carlos Campagnari a
a
Urology Clinic, Hospital Beneficência Portuguesa of São Paulo, São Paulo, and b Urology Department, Hospital Santa Helena of São Paulo, São Paulo, Brazil
Key Words Incontinence · Urodynamics · Detrusor · Bladder · Voiding dysfunctions
tion is a necessary procedure where IDC is important to demonstrate, as its false-negative rate is high and its unpredictable pattern of detection may be improved by repetition. © 2015 S. Karger AG, Basel
© 2015 S. Karger AG, Basel 0042–1138/15/0951–0086$39.50/0 E-Mail [email protected] www.karger.com/uin
Introduction
Urodynamic investigation (UD) is the most useful and objective tool in accessing voiding function but it may dramatically vary according to a multitude of tangible and intangible factors that frustrate clinicians because of its unreliable nature. The velocity of bladder filling, caliber of monitoring tubes and temperature of the infused fluid are a few among the many tangible factors that have been standardized to more reproducible results. Anxiety of the patient, experience of the operator, interactiveness during the exam and natural biological variations cannot be measured, but they may objectively interfere with the results. Although no clear definition on when to repeat the exam has been established, it is the unique way to give reliability to an exam that may undesirably vary [1]. Paulo Rodrigues, MD Rua Teixeira da Silva 34 – 1° andar CEP–04002–030 São Paulo (Brazil) E-Mail paulortrodrigues @ uol.com.br
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Abstract Aims: Involuntary Detrusor Contraction (IDC) may alter therapeutic plans; therefore, urodynamic demonstration (UD) is pivotal. We explore if same session repetitions enhance its demonstration and minimize false-negative results. Methods: Two hundred fifty two women (mean age 47 ± 5.7) had 4 full repetitions of UD with the last round filled with 4 ° C fluid (Icewater test). IDC was diagnosed if with at least 3 cm H2O after artifacts were ruled out. Results: 44.4% of the cases showed IDC in the first round of the exam but it could be demonstrated in 88.5% of the women if 4 rounds are taken into account. Only 2 cases showed IDC exclusively in the first round. Nine cases (3.5%) showed IDC in the first round and only on Ice-test, while all other IDC-detected cases revealed it in scattered patterns along the repetitions. Likewise, IDC detection on the second, third and fourth rounds varied widely and unpredictably, many failing to show a consistent pattern of presentation after its detection. IDC wave amplitude did not show any correlation to the detection. Conclusions: Urodynamic repeti-
Material and Methods From a long time, we have been deliberately repeating the exams in the same session to guarantee high-quality performance of the graphics and reproduction of the observed data. Women were referred to as part of the investigation prior to prolapses operations, SUI, failed cases or recurrent UTI. Our routine study comprehended 3 to 8 repetitions (at least 3) in the same session and a fourth repetition with cold-saline solution at 4 ° C – Ice-water test despite more repetitions. The study procedure was explained and written consent obtained. Our prospective database consisting of 1,200 female urodynamic studies referred to our tertiary urodynamic clinic allowed the selection of appropriate cases that could be analyzed. All women were sent 2 urinary symptoms questionnaires (UDI and IPSS). The selected cases presented frequency, urgency, urgeincontinence and/or nocturia as main or additional clinical complaint characterizing OAB syndrome. Women taking anticholinergic drugs, those with a history of recurrent urinary tract infections, active urinary tract infection or prolapse greater than grade III were all excluded from the study. Urodynamic studies were done according to the good urodynamic practices recommended by the International Continence Society [1]. Patients were investigated in the sitting position after a free flow rate was first conducted in privacy after attending with a comfortably full bladder. Only patients that referred to voiding in the sitting position were selected.
Can We State Stable Bladder?
A double lumen 6Fr transurethral catheter was used to fill and monitor the bladder pressure at a filling rate of 50 ml/min in all exams. The bladder was filled with a 37 ° C mixture of saline solution. At 100 ml intervals maneuvers were undertaken. The women were asked to cough to detect any leakage of urine. Running water and hand washing with cold water were also performed to provoke detrusor overactivity. Finally, patients were allowed to void in the sitting position and a pressure-flow study was recorded when the patient manifested a strong desire to void but with no pain and with no interference from the examiner to postpone the desire beyond 600 ml. If the intubated woman was unable to void, all lines were removed to allow free flow and the exam repeated. All patients had filling cystometry and pressure-flow studies repeated immediately at least 4 times in the same session. A multichannel urodynamic system (Aquarius XLT®, Laborie Medical Tech, Vermont, USA) was used for measurement. After each UD the bladder was completely emptied by the same urethral catheter. Parameters assessed during filling cystometry were maximum cystometric capacity, bladder compliance, maximum detrusor pressure during storage, the presence or absence of detrusor overactivity and detrusor leak point pressure. Parameters assessed during pressure-flow studies were maximum flow rate, maximum detrusor pressure during voiding phase, voided volume and postvoid residual urine. IDC was diagnosed on the detrusor line if it showed up with at least 3 cm H2O in amplitude and return to the previous pressure line on additional filling. This pressure cutoff was set because it represented the lowest detrusor pressure amplitude possibly detected with certainty as a true detrusor contraction. To ascertain its presence if detected the patient was recommended to breath calmly, stop talking or moving and only then the wave form was detected and confirmed, guaranteeing the lack of any artifact. Low compliance traces were considered having IDC if there were similar IDC waves as specified. We restricted the study to good-quality, pressure-flow tracings. Difference and correlation between paired values and occurrences of IDC were analyzed by the Wilcoxon signed rank test and Spearman rank correlation for p < 0.05 in a 2-tailed analysis. The authors consulted both IRB of the involved hospitals and both stated there was no need for approval by them as urodynamic studies are part of the regular investigational armamentarium.
Results
We selected 279 cases where 4 urodynamic evaluations were available and repeated in the same session with the last one using 4 ° C cold-saline solution – Ice-water test. Other cases that did not obey this exclusive protocol were excluded from the present analysis. The mean age of the studied population was 47 (±5.7; range 28 to 67) with median parity of 2.1 (±0.3). Three cases did not want to enter into the study, 11 cases did not present outstanding traces in the 4 performances and were excluded from analysis and 13 cases
Urol Int 2015;95:86–91 DOI: 10.1159/000370163
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Recently, the mounting interest on overactive bladder syndrome (OAB) to some extent relieved the dilemma of patients by providing them with complete details on clinical urgency and urge-incontinence complaints and normality on UD. Notwithstanding the legal aspects, this latter situation is especially embarrassing for sling-operated patients where the clinical picture is clear but the diagnosis of detrusor overactivity and obstruction does not obey a defined rule [2] and may impede proper treatment. This undesired scenario of a mismatch between clinical complaint and urodynamic finding is particularly important for women to be operated where the presence of urodynamic detrusor overactivity may impact the best possible result, impeding a frank and realistic discussion about the outcomes [3–5]. Maneuvers to discover occult IDC may enhance its reproducibility and improve the reliability of the UD in particular cases where the standard has not yet been set. We hypothesized that women candidates to surgical treatment for bladder dysfunctions where the detection of IDC was absent in the first set might be brought out by repetition. Moreover, we also tested if Ice-water test would improve the detection rate of IDC on investigated adult women as a sensitizer maneuver.
tions, showing an unexpected and scattered behavior for the demonstration of IDC on the repetitions. % Only 29 (11.5%) of the 252 cases of the studied popula100 tion did not present IDC in any of four urodynamic repetitions being absolutely true ‘negative.’ They were con80 117 126 127 sidered normal exams (11 cases –4.3%) or sensory urgen140 cy (18 cases –7.1%) as an urge to void was stated early by 60 the patient but no IDC could be detected. Analysis on the amplitude of the IDC did not show any 40 reproducible pattern or statistical trend as shown in figure 2 where extreme variations on the amplitude of the 135 112 127 126 20 IDC could be observed in the same case along with the sequence of repetitions. The urodynamic Ice-test was positive in 152 cases 0 1 2 3 4 (68.5%), a statistically significant difference in compariUrodynamic investigation round son to the detection rate of IDC for our first round conventional urodynamic (p < 0.05). One hundred and forty eight cases (58.7% of 252 cases) Fig. 1. IDC detection rate in each of the urodynamic investigation. were sensitized by the Ice-test on the demonstration of the IDC and showed IDC on the test. Of these cases, 24 could not void with intubated lines leaving 252 cases as subjects (9.5% of 252 or 16.2% of 148 positive ice-tested) our studied population. revealed IDC only on the Ice-test repetition and not in One hundred and twelve cases (44.4% of the 252 cases) one of the anterior repetitions. submitted to conventional urodynamic showed IDC on Likewise, 104 cases (41.2% of 252) were negative on the the first round of the exam, while 140 cases (55.5% of 252 ice-test repetition with 80 cases (77% of 104) revealing cases) did not reveal it. IDC on any of the anterior repetitions. As a whole, the However, when the incidence of IDC was computed group did not produce any statistical trend predicting on the 4 repetitions the detection rate was elevated to IDC appearance. 88.5% (223/252 cases). Direct comparison between the first round and the iceOnly 2 cases (0.8%) with demonstrable IDC had it only test repetition revealed a disconcert on agreement bein the first round and absence was noticed in the remain- tween both cystometries (κ = –20%). Of the 112 cases ing rounds. (44.4% of 252) where IDC was demonstrated on the first Nine cases (3.5%) also failed to show it in the second round, 55 (21.8%) were negative on the Ice-test repetiand third repetitions with reappearance of the IDC on tion. In opposition, 140 cases (55.5% of 252) had negative the Ice-test exam (fourth-round). In all other cases in IDC on the first exam but 75 cases (29.1%) had it demonwhich IDC was detected, it was discovered in scattered strated on the Ice-test. patterns in any of the 3 other repetitions, –as shown in First cystometry and ice-test were congruent on the figure 1. demonstration of IDC only in 26.9% of the cases (68 of In 112 cases where IDC did not appear on the first 252), while they were both negative in 12.6% (32 of 252). exam, it did appear afterwards in at least one of any of the Comparing the first and Ice-test exam together they 3 additional urodynamic repetitions being 60 cases with presented sensibility of 0.44, specificity of 0.38, and posithe first and the second rounds negative and in 20 cases tive and negative predictive value of 0.56 and 0.38, respecwhere the first, second and third were negative rounds tively. but they only responded to the Ice-test exam (κ = –17%). Eight cases did not show IDC on the first 2 repetitions Discussion but did so only in the third repetition. Surprisingly, 28 cases showed an inconsistent pattern The hallmark physiological variation of the bladder of IDC after the second round of the exam (first repetition) switching from IDC demonstrated on the second may limit the consistency and reproducibility of many round to IDC negative on the third and fourth repeti- urodynamic parameters. 88
Urol Int 2015;95:86–91 DOI: 10.1159/000370163
Rodrigues/Hering/Cieli/D’Imperio/ Campagnari
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IDC not detected IDC detected
70
IDC amplitude (cm H2O)
60 50 40 30 20 10 0
Fig. 2. IDC detection rate in patients sub-
mitted to urodynamic investigation in which IDC was detected at least in 2 rounds.
1
2 3 Urodynamic test repetition
1
2 3 Urodynamic repetition
Ice-test
45
UDI amplitude (cm H2O)
40 35 30 25 20 15 10 5
to urodynamic investigation with negative Ice-test.
Ice-test
As often the case, fluctuations in detrusor pressure measurement do not alter any clinical question but the subtle or overlooked presence of involuntary detrusor contraction (IDC) as so-called involuntary detrusor overactivity may alter the conceptions on the causes of voiding dysfunctions and complaints as well as the appropriateness of its treatment. Digesu et al. [6] claimed that intrapatient variations for detrusor parameters during ambulatory urodynamics are minimal and do not require repetition. Hence, ambulatory urodynamics seems to reproduce bladder behavior more accurately than conventional urodynamic where its nonphysiological reproductive cycle does not reflect true bladder behavior being more prone to artifacts and individual adaptation, thus leading to more false-negative results.
As demonstrated in the placebo arm of OAB studies, 25% of patients presenting IDC in one session may switch to negative finding in another session or vice-versa [7]. Additionally, the diagnosis and detection of IDC depend on skilled and trained specialists with its detection rate varying across different laboratories and sets. Contrary to neurogenic patients where detrusor overactivity shows excellent repeatability [8], women with non-neurogenic dysfunctions demand repetition to ascertain its presence. For patients with IDC the variability of the urodynamic parameters is wider than for voluntarily asymptomatic enrolled cases with 93% of the former showing >10% variation in the amplitude of IDC as well as demonstration of IDC if a second session is done some weeks apart [9]. Although Homma’s study [9] ana-
Can We State Stable Bladder?
Urol Int 2015;95:86–91 DOI: 10.1159/000370163
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0
Fig. 3. IDC pattern on patients submitted
90
Urol Int 2015;95:86–91 DOI: 10.1159/000370163
portant set of variations based on demand, personal preferences and even personal interest and professional training on voiding dysfunction that hamper direct comparisons among studies. Minor IDC amplitude may be difficult to diagnose and requires demanding experience from the examiner who may interact with the patient ordering calm breathing, no talking, etc. However, despite the large number of studied cases only 4 in 252 cases had had IDC of 4 cm H2O. All the rest had had higher amplitude facilitating visual diagnosis on the lines easily eliminating the possibility of artefactual finding. It is common place in urodynamic practice to only state the presence or absence of the detection of IDC, thus simplistically reducing its urodynamic meaning and undervaluing its diagnosis because this kind of parameter varies in amplitude and defines different clinical meanings [15]. We proved that patients with no demonstrable IDC in the first session may present it during the second or third session in scattered patterns. But mostly important is the fact that a positive IDC demonstration in the second session does not assert its appearance in a row. Furthermore, the use of the additional sensitizer Icewater test in the same session unravels some additional cases. Our study showed that Ice-test could unravel additional 9.5% cases in which all the 3 anterior repetitions were negative. Additionally, 54% of the cases where IDC was not observed on the first cystometry were subsequently demonstrated on the Ice-test repetition. If one takes into account that only 44.4% of the cases showed IDC on first cystometry, one may estimate a near 100% of IDC demonstration if the examiner insists on the repetitions and stimulation maneuvers to demonstrate IDC if the presenting clinical picture suggests its presence. In our studied population, IDC demonstration reached 89% of the suspected cases, a much higher prevalence for IDC detection rate than the diagnosis rate for 1 set of UD. Moreover, taking Ice-test alone was positive in 152 cases (68.5%), a statistically significant and enhanced difference in comparison to the detection rate of IDC obtained at single and conventional urodynamic session (44.4%). We cannot ascertain that the flaws contained on the fact that we used warmed fluid on the first session and Ice-test only on the fourth as we did accordingly to our protocol what might interfere with the detection rate of IDC on the first filling if we did otherwise but the protocol intended to compare what is observed in common practice in many urodynamic laboratories. Rodrigues/Hering/Cieli/D’Imperio/ Campagnari
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lyzed the placebo arm of a drug clinical trial his population was not uniform and eliciting maneuvers was not used in his supine cystometry study as in our population. IDC demonstration rate seems to reflect a composite of many aspects of the urodynamic exam, which may be influenced by the filling rate, temperature of the infused fluid, number of repetition and even position of the patient during the exam. In this regard, we chose the sitting position as it was demonstrated to enhance the IDC detection rate [10]. Our study did not show good reproducibility of IDC on the 4 repetitions in a row on the amplitude of the detected IDC, contradicting the findings of Broekhuis et cols who showed a good coefficient of correlation on the 2 same sessions repeated cystometries although the IDC amplitude could not be anticipated or reproduced [11]. As our experience revealed, very poor relationship between the first, second and the fourth repetitions, we believe IDC demonstration can be enhanced only if repetition became a gold-standard. In a different study to unveil the dysfunctional bladder in erroneously assumed normal patients with recurrent UTI, 3 sets of cystometries in the same session were necessary to demonstrate it [12]. Likewise, Rahmanou et al. were unable to show normal distribution of any urodynamic parameters in 2 separate exams in women with SUI with or without IDC exposing the lack of repeatability of some parameters in women with OAB [13]. Our study reinforces the idea and necessity of repeating cystometries in women to detect IDC as there was no predictability of IDC detection on subsequent UD if it were detected or not on the anterior session. Our criticism was based on many generalized and intuitive but erroneous assumption that second or third repetitions present the same rate of IDC detection but with the majority of the studies analyzing patients gathered by the group of diagnosis and not analyzing individual patients reinforcing this false assumption. Moreover, there is no agreement on the amplitude of which detrusor variation may be relevant in the absence of a clinical desire to void as well as there is no agreement on the significance of the presence of clinical urgency or desire to void and no measured IDC. Whiteside et cols. demonstrated poor correlation of within and across-physician groups on the detection of IDC in 100 masked cases analyzed twice 4 months apart [14]. Hence, low-amplitude IDC during cystometry may be overlooked or personally interpreted as nonsignificant. In addition, urodynamic laboratories present im-
Acknowledgement on the limitations of the urodynamic testing is essential, allowing us to realize the necessity of repetition on critical cases as a strategy to optimize the diagnostic statements.
prediction demands adoption of urodynamic repetition as a strategy where IDC may facilitate good therapeutic plan or prevent poor clinical result. Financial Support
Conclusions
None.
A single session of standard urodynamic seems to be inadequate and insufficient to capture IDC. The addition of Ice-test maneuver may enhance IDC demonstrability in a set of patients but the lack of statistical or individual
Disclosure Statement None declared.
References
Can We State Stable Bladder?
7 Andersen JR, Lose G, Norgaard M, et al: Terodiline, emepronium bromide or placebo for treatment of female detrusor overactivity? A randomised, double-blind, cross-over study. Br J Urol 1988;61:310–313. 8 Bellucci CH, Wöllner J, Gregorini F, Birnböck D, Kozomara M, Mehnert U, Kessler TM: Neurogenic lower urinary tract dysfunction – do we need same session repeat urodynamic investigations? J Urol 2012;187:1318–1323. 9 Homma Y, Kondo Y, Takahashi S, Kitamura T, Kawabe K: Reproducibility of cystometry in overactive detrusor. Eur Urol 2000;38:681– 685. 10 Al-Hayek S, Belal M, Abrams P: Does the patient’s position influence the detection of detrusor overactivity? Neurourol Urodyn 2008; 27:279–286.
Urol Int 2015;95:86–91 DOI: 10.1159/000370163
11 Broekhuis SR, Kluivers KB, Hendriks JC, et al: Reproducibility of same session repeated cystometry and pressure-flow studies in women with symptoms of urinary incontinence. Neurourol Urodyn 2011; 30: 1356– 1360. 12 Rodrigues P, Hering F, Campagnari JC: Involuntary detrusor contraction is a frequent finding in patients with recurrent urinary tract infections. Urol Int 2014;93:67–73. 13 Rahmanou P, Chaliha C, Kulinskaya E, Khullar V: Reliability testing of urodynamics, pressure flow studies and cough leak point pressure in women with urodynamic stress incontinence with and without detrusor overactivity. Int Urogynecol J Pelvic Floor Dysfunct 2008;19:933–938. 14 Whiteside JL, Hijaz A, Imrey PB, Barber MD, Paraiso MF, Rackley RR, Vasavada SP, Walters MD, Daneshgari F: Reliability and agreement of urodynamics interpretations in a female pelvic medicine center. Obstet Gynecol 2006;108:315–323. 15 Bland JM, Altman DG: Measuring agreement in method comparison studies. Stat Methods Med Res 1999;8:135–160.
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1 Schafer W, Abrams P, Liao L, et al: Good urodynamic practices: uroflowmetry, filling cystometry, and pressure-flow studies. Neurourol Urodyn 2002;21:261–274. 2 Rodrigues P, Hering F, Dias EC: Female obstruction after incontinence surgery may present different urodynamic patterns. Int Urogynecol J 2013;24:331–336. 3 Kulseng-Hanssen S, Husby H, Schiotz HA: Follow-up of TVT operations in 1,113 women with mixed urinary incontinence at 7 and 38 months. Int Urogynecol J Pelvic Floor Dysfunct 2008;19:391–396. 4 Schrepferman CG, Griebling TL, Nygaard IE, et al: Resolution of urge symptoms following sling cystourethropexy. J Urol 2000; 164: 1628–1631. 5 Hsiao SM, Chang TC, Lin HH: Risk factors affecting cure after mid-urethral tape procedure for female urodynamic stress incontinence: comparison of retropubic and transobturator routes. Urology 2009;73:981–986. 6 Digesu GA, Hutchings A, Salvatore S, Selvaggi L, Khullar V: Reproducibility and reliability of pressure flow parameters in women. BJOG 2003;110:774–776.
Urologia
Received: September 8, 2014 Accepted after revision: November 24, 2014 Published online: January 31, 2015
Urol Int 2015;95:86–91 DOI: 10.1159/000370163
Internationalis
Can We State Stable Bladder? How Many Repetitions Should We Do for an Appropriate Demonstration of Involuntary Detrusor Contraction? Paulo Rodrigues a, b Flávio Hering a, b Eli Cieli a, b Marcio D’Imperio a João Carlos Campagnari a
a
Urology Clinic, Hospital Beneficência Portuguesa of São Paulo, São Paulo, and b Urology Department, Hospital Santa Helena of São Paulo, São Paulo, Brazil
Key Words Incontinence · Urodynamics · Detrusor · Bladder · Voiding dysfunctions
tion is a necessary procedure where IDC is important to demonstrate, as its false-negative rate is high and its unpredictable pattern of detection may be improved by repetition. © 2015 S. Karger AG, Basel
© 2015 S. Karger AG, Basel 0042–1138/15/0951–0086$39.50/0 E-Mail [email protected] www.karger.com/uin
Introduction
Urodynamic investigation (UD) is the most useful and objective tool in accessing voiding function but it may dramatically vary according to a multitude of tangible and intangible factors that frustrate clinicians because of its unreliable nature. The velocity of bladder filling, caliber of monitoring tubes and temperature of the infused fluid are a few among the many tangible factors that have been standardized to more reproducible results. Anxiety of the patient, experience of the operator, interactiveness during the exam and natural biological variations cannot be measured, but they may objectively interfere with the results. Although no clear definition on when to repeat the exam has been established, it is the unique way to give reliability to an exam that may undesirably vary [1]. Paulo Rodrigues, MD Rua Teixeira da Silva 34 – 1° andar CEP–04002–030 São Paulo (Brazil) E-Mail paulortrodrigues @ uol.com.br
Downloaded by: University of Hong Kong 198.143.53.1 - 1/28/2016 5:23:09 AM
Abstract Aims: Involuntary Detrusor Contraction (IDC) may alter therapeutic plans; therefore, urodynamic demonstration (UD) is pivotal. We explore if same session repetitions enhance its demonstration and minimize false-negative results. Methods: Two hundred fifty two women (mean age 47 ± 5.7) had 4 full repetitions of UD with the last round filled with 4 ° C fluid (Icewater test). IDC was diagnosed if with at least 3 cm H2O after artifacts were ruled out. Results: 44.4% of the cases showed IDC in the first round of the exam but it could be demonstrated in 88.5% of the women if 4 rounds are taken into account. Only 2 cases showed IDC exclusively in the first round. Nine cases (3.5%) showed IDC in the first round and only on Ice-test, while all other IDC-detected cases revealed it in scattered patterns along the repetitions. Likewise, IDC detection on the second, third and fourth rounds varied widely and unpredictably, many failing to show a consistent pattern of presentation after its detection. IDC wave amplitude did not show any correlation to the detection. Conclusions: Urodynamic repeti-
Material and Methods From a long time, we have been deliberately repeating the exams in the same session to guarantee high-quality performance of the graphics and reproduction of the observed data. Women were referred to as part of the investigation prior to prolapses operations, SUI, failed cases or recurrent UTI. Our routine study comprehended 3 to 8 repetitions (at least 3) in the same session and a fourth repetition with cold-saline solution at 4 ° C – Ice-water test despite more repetitions. The study procedure was explained and written consent obtained. Our prospective database consisting of 1,200 female urodynamic studies referred to our tertiary urodynamic clinic allowed the selection of appropriate cases that could be analyzed. All women were sent 2 urinary symptoms questionnaires (UDI and IPSS). The selected cases presented frequency, urgency, urgeincontinence and/or nocturia as main or additional clinical complaint characterizing OAB syndrome. Women taking anticholinergic drugs, those with a history of recurrent urinary tract infections, active urinary tract infection or prolapse greater than grade III were all excluded from the study. Urodynamic studies were done according to the good urodynamic practices recommended by the International Continence Society [1]. Patients were investigated in the sitting position after a free flow rate was first conducted in privacy after attending with a comfortably full bladder. Only patients that referred to voiding in the sitting position were selected.
Can We State Stable Bladder?
A double lumen 6Fr transurethral catheter was used to fill and monitor the bladder pressure at a filling rate of 50 ml/min in all exams. The bladder was filled with a 37 ° C mixture of saline solution. At 100 ml intervals maneuvers were undertaken. The women were asked to cough to detect any leakage of urine. Running water and hand washing with cold water were also performed to provoke detrusor overactivity. Finally, patients were allowed to void in the sitting position and a pressure-flow study was recorded when the patient manifested a strong desire to void but with no pain and with no interference from the examiner to postpone the desire beyond 600 ml. If the intubated woman was unable to void, all lines were removed to allow free flow and the exam repeated. All patients had filling cystometry and pressure-flow studies repeated immediately at least 4 times in the same session. A multichannel urodynamic system (Aquarius XLT®, Laborie Medical Tech, Vermont, USA) was used for measurement. After each UD the bladder was completely emptied by the same urethral catheter. Parameters assessed during filling cystometry were maximum cystometric capacity, bladder compliance, maximum detrusor pressure during storage, the presence or absence of detrusor overactivity and detrusor leak point pressure. Parameters assessed during pressure-flow studies were maximum flow rate, maximum detrusor pressure during voiding phase, voided volume and postvoid residual urine. IDC was diagnosed on the detrusor line if it showed up with at least 3 cm H2O in amplitude and return to the previous pressure line on additional filling. This pressure cutoff was set because it represented the lowest detrusor pressure amplitude possibly detected with certainty as a true detrusor contraction. To ascertain its presence if detected the patient was recommended to breath calmly, stop talking or moving and only then the wave form was detected and confirmed, guaranteeing the lack of any artifact. Low compliance traces were considered having IDC if there were similar IDC waves as specified. We restricted the study to good-quality, pressure-flow tracings. Difference and correlation between paired values and occurrences of IDC were analyzed by the Wilcoxon signed rank test and Spearman rank correlation for p < 0.05 in a 2-tailed analysis. The authors consulted both IRB of the involved hospitals and both stated there was no need for approval by them as urodynamic studies are part of the regular investigational armamentarium.
Results
We selected 279 cases where 4 urodynamic evaluations were available and repeated in the same session with the last one using 4 ° C cold-saline solution – Ice-water test. Other cases that did not obey this exclusive protocol were excluded from the present analysis. The mean age of the studied population was 47 (±5.7; range 28 to 67) with median parity of 2.1 (±0.3). Three cases did not want to enter into the study, 11 cases did not present outstanding traces in the 4 performances and were excluded from analysis and 13 cases
Urol Int 2015;95:86–91 DOI: 10.1159/000370163
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Recently, the mounting interest on overactive bladder syndrome (OAB) to some extent relieved the dilemma of patients by providing them with complete details on clinical urgency and urge-incontinence complaints and normality on UD. Notwithstanding the legal aspects, this latter situation is especially embarrassing for sling-operated patients where the clinical picture is clear but the diagnosis of detrusor overactivity and obstruction does not obey a defined rule [2] and may impede proper treatment. This undesired scenario of a mismatch between clinical complaint and urodynamic finding is particularly important for women to be operated where the presence of urodynamic detrusor overactivity may impact the best possible result, impeding a frank and realistic discussion about the outcomes [3–5]. Maneuvers to discover occult IDC may enhance its reproducibility and improve the reliability of the UD in particular cases where the standard has not yet been set. We hypothesized that women candidates to surgical treatment for bladder dysfunctions where the detection of IDC was absent in the first set might be brought out by repetition. Moreover, we also tested if Ice-water test would improve the detection rate of IDC on investigated adult women as a sensitizer maneuver.
tions, showing an unexpected and scattered behavior for the demonstration of IDC on the repetitions. % Only 29 (11.5%) of the 252 cases of the studied popula100 tion did not present IDC in any of four urodynamic repetitions being absolutely true ‘negative.’ They were con80 117 126 127 sidered normal exams (11 cases –4.3%) or sensory urgen140 cy (18 cases –7.1%) as an urge to void was stated early by 60 the patient but no IDC could be detected. Analysis on the amplitude of the IDC did not show any 40 reproducible pattern or statistical trend as shown in figure 2 where extreme variations on the amplitude of the 135 112 127 126 20 IDC could be observed in the same case along with the sequence of repetitions. The urodynamic Ice-test was positive in 152 cases 0 1 2 3 4 (68.5%), a statistically significant difference in compariUrodynamic investigation round son to the detection rate of IDC for our first round conventional urodynamic (p < 0.05). One hundred and forty eight cases (58.7% of 252 cases) Fig. 1. IDC detection rate in each of the urodynamic investigation. were sensitized by the Ice-test on the demonstration of the IDC and showed IDC on the test. Of these cases, 24 could not void with intubated lines leaving 252 cases as subjects (9.5% of 252 or 16.2% of 148 positive ice-tested) our studied population. revealed IDC only on the Ice-test repetition and not in One hundred and twelve cases (44.4% of the 252 cases) one of the anterior repetitions. submitted to conventional urodynamic showed IDC on Likewise, 104 cases (41.2% of 252) were negative on the the first round of the exam, while 140 cases (55.5% of 252 ice-test repetition with 80 cases (77% of 104) revealing cases) did not reveal it. IDC on any of the anterior repetitions. As a whole, the However, when the incidence of IDC was computed group did not produce any statistical trend predicting on the 4 repetitions the detection rate was elevated to IDC appearance. 88.5% (223/252 cases). Direct comparison between the first round and the iceOnly 2 cases (0.8%) with demonstrable IDC had it only test repetition revealed a disconcert on agreement bein the first round and absence was noticed in the remain- tween both cystometries (κ = –20%). Of the 112 cases ing rounds. (44.4% of 252) where IDC was demonstrated on the first Nine cases (3.5%) also failed to show it in the second round, 55 (21.8%) were negative on the Ice-test repetiand third repetitions with reappearance of the IDC on tion. In opposition, 140 cases (55.5% of 252) had negative the Ice-test exam (fourth-round). In all other cases in IDC on the first exam but 75 cases (29.1%) had it demonwhich IDC was detected, it was discovered in scattered strated on the Ice-test. patterns in any of the 3 other repetitions, –as shown in First cystometry and ice-test were congruent on the figure 1. demonstration of IDC only in 26.9% of the cases (68 of In 112 cases where IDC did not appear on the first 252), while they were both negative in 12.6% (32 of 252). exam, it did appear afterwards in at least one of any of the Comparing the first and Ice-test exam together they 3 additional urodynamic repetitions being 60 cases with presented sensibility of 0.44, specificity of 0.38, and posithe first and the second rounds negative and in 20 cases tive and negative predictive value of 0.56 and 0.38, respecwhere the first, second and third were negative rounds tively. but they only responded to the Ice-test exam (κ = –17%). Eight cases did not show IDC on the first 2 repetitions Discussion but did so only in the third repetition. Surprisingly, 28 cases showed an inconsistent pattern The hallmark physiological variation of the bladder of IDC after the second round of the exam (first repetition) switching from IDC demonstrated on the second may limit the consistency and reproducibility of many round to IDC negative on the third and fourth repeti- urodynamic parameters. 88
Urol Int 2015;95:86–91 DOI: 10.1159/000370163
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IDC not detected IDC detected
70
IDC amplitude (cm H2O)
60 50 40 30 20 10 0
Fig. 2. IDC detection rate in patients sub-
mitted to urodynamic investigation in which IDC was detected at least in 2 rounds.
1
2 3 Urodynamic test repetition
1
2 3 Urodynamic repetition
Ice-test
45
UDI amplitude (cm H2O)
40 35 30 25 20 15 10 5
to urodynamic investigation with negative Ice-test.
Ice-test
As often the case, fluctuations in detrusor pressure measurement do not alter any clinical question but the subtle or overlooked presence of involuntary detrusor contraction (IDC) as so-called involuntary detrusor overactivity may alter the conceptions on the causes of voiding dysfunctions and complaints as well as the appropriateness of its treatment. Digesu et al. [6] claimed that intrapatient variations for detrusor parameters during ambulatory urodynamics are minimal and do not require repetition. Hence, ambulatory urodynamics seems to reproduce bladder behavior more accurately than conventional urodynamic where its nonphysiological reproductive cycle does not reflect true bladder behavior being more prone to artifacts and individual adaptation, thus leading to more false-negative results.
As demonstrated in the placebo arm of OAB studies, 25% of patients presenting IDC in one session may switch to negative finding in another session or vice-versa [7]. Additionally, the diagnosis and detection of IDC depend on skilled and trained specialists with its detection rate varying across different laboratories and sets. Contrary to neurogenic patients where detrusor overactivity shows excellent repeatability [8], women with non-neurogenic dysfunctions demand repetition to ascertain its presence. For patients with IDC the variability of the urodynamic parameters is wider than for voluntarily asymptomatic enrolled cases with 93% of the former showing >10% variation in the amplitude of IDC as well as demonstration of IDC if a second session is done some weeks apart [9]. Although Homma’s study [9] ana-
Can We State Stable Bladder?
Urol Int 2015;95:86–91 DOI: 10.1159/000370163
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0
Fig. 3. IDC pattern on patients submitted
90
Urol Int 2015;95:86–91 DOI: 10.1159/000370163
portant set of variations based on demand, personal preferences and even personal interest and professional training on voiding dysfunction that hamper direct comparisons among studies. Minor IDC amplitude may be difficult to diagnose and requires demanding experience from the examiner who may interact with the patient ordering calm breathing, no talking, etc. However, despite the large number of studied cases only 4 in 252 cases had had IDC of 4 cm H2O. All the rest had had higher amplitude facilitating visual diagnosis on the lines easily eliminating the possibility of artefactual finding. It is common place in urodynamic practice to only state the presence or absence of the detection of IDC, thus simplistically reducing its urodynamic meaning and undervaluing its diagnosis because this kind of parameter varies in amplitude and defines different clinical meanings [15]. We proved that patients with no demonstrable IDC in the first session may present it during the second or third session in scattered patterns. But mostly important is the fact that a positive IDC demonstration in the second session does not assert its appearance in a row. Furthermore, the use of the additional sensitizer Icewater test in the same session unravels some additional cases. Our study showed that Ice-test could unravel additional 9.5% cases in which all the 3 anterior repetitions were negative. Additionally, 54% of the cases where IDC was not observed on the first cystometry were subsequently demonstrated on the Ice-test repetition. If one takes into account that only 44.4% of the cases showed IDC on first cystometry, one may estimate a near 100% of IDC demonstration if the examiner insists on the repetitions and stimulation maneuvers to demonstrate IDC if the presenting clinical picture suggests its presence. In our studied population, IDC demonstration reached 89% of the suspected cases, a much higher prevalence for IDC detection rate than the diagnosis rate for 1 set of UD. Moreover, taking Ice-test alone was positive in 152 cases (68.5%), a statistically significant and enhanced difference in comparison to the detection rate of IDC obtained at single and conventional urodynamic session (44.4%). We cannot ascertain that the flaws contained on the fact that we used warmed fluid on the first session and Ice-test only on the fourth as we did accordingly to our protocol what might interfere with the detection rate of IDC on the first filling if we did otherwise but the protocol intended to compare what is observed in common practice in many urodynamic laboratories. Rodrigues/Hering/Cieli/D’Imperio/ Campagnari
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lyzed the placebo arm of a drug clinical trial his population was not uniform and eliciting maneuvers was not used in his supine cystometry study as in our population. IDC demonstration rate seems to reflect a composite of many aspects of the urodynamic exam, which may be influenced by the filling rate, temperature of the infused fluid, number of repetition and even position of the patient during the exam. In this regard, we chose the sitting position as it was demonstrated to enhance the IDC detection rate [10]. Our study did not show good reproducibility of IDC on the 4 repetitions in a row on the amplitude of the detected IDC, contradicting the findings of Broekhuis et cols who showed a good coefficient of correlation on the 2 same sessions repeated cystometries although the IDC amplitude could not be anticipated or reproduced [11]. As our experience revealed, very poor relationship between the first, second and the fourth repetitions, we believe IDC demonstration can be enhanced only if repetition became a gold-standard. In a different study to unveil the dysfunctional bladder in erroneously assumed normal patients with recurrent UTI, 3 sets of cystometries in the same session were necessary to demonstrate it [12]. Likewise, Rahmanou et al. were unable to show normal distribution of any urodynamic parameters in 2 separate exams in women with SUI with or without IDC exposing the lack of repeatability of some parameters in women with OAB [13]. Our study reinforces the idea and necessity of repeating cystometries in women to detect IDC as there was no predictability of IDC detection on subsequent UD if it were detected or not on the anterior session. Our criticism was based on many generalized and intuitive but erroneous assumption that second or third repetitions present the same rate of IDC detection but with the majority of the studies analyzing patients gathered by the group of diagnosis and not analyzing individual patients reinforcing this false assumption. Moreover, there is no agreement on the amplitude of which detrusor variation may be relevant in the absence of a clinical desire to void as well as there is no agreement on the significance of the presence of clinical urgency or desire to void and no measured IDC. Whiteside et cols. demonstrated poor correlation of within and across-physician groups on the detection of IDC in 100 masked cases analyzed twice 4 months apart [14]. Hence, low-amplitude IDC during cystometry may be overlooked or personally interpreted as nonsignificant. In addition, urodynamic laboratories present im-
Acknowledgement on the limitations of the urodynamic testing is essential, allowing us to realize the necessity of repetition on critical cases as a strategy to optimize the diagnostic statements.
prediction demands adoption of urodynamic repetition as a strategy where IDC may facilitate good therapeutic plan or prevent poor clinical result. Financial Support
Conclusions
None.
A single session of standard urodynamic seems to be inadequate and insufficient to capture IDC. The addition of Ice-test maneuver may enhance IDC demonstrability in a set of patients but the lack of statistical or individual
Disclosure Statement None declared.
References
Can We State Stable Bladder?
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Urol Int 2015;95:86–91 DOI: 10.1159/000370163
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