Urodynamics Mismatch - Should We Listen to the Study, or the Patient?

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1 Urodynamics Mismatch - Should We Listen to the Study, or the Patient? A Practical Approach to the Diagnosis and Treatment of Lower Urinary Tract Dysfunction Victor W. Nitti MD Professor of Urology and Obstetrics and Gynecology Vice Chairman Department of Urology Director of FPMRS NYU Langone Medical Center

2 When it Doesn t Make Sense, or Even if it Does, Don t Forget to Think

3 Disclosures Investigator Allergan Investigator Astellas Investigator - Medtronics Chair of Education, American Urological Association

4 Disclosure #2 This talk is only partially evidence-based and very much philosophical, based on 25 years of victories and failures and learning something new almost every day

5 Challenge Dogma

6 Definitions Guideline evidence-based guidance with an explicit clinical scope and purpose RCT and robust non-rct data Best Practice evidence-based guidance that reflects the principals of the urologic profession Literature reviewed, no data analysis

7 Definitions Physician (Merriam-Webster) - a person skilled in the art of healing; specifically : one educated, clinically experienced, and licensed to practice medicine as usually distinguished from surgery

8 The Science of Treating LUTS LUTS are caused by a specific etiology(s) or dysfunction Exactly defining that etiology leads to the most effective treatment

9 The Art of Treating LUTS Different symptoms affect different patients differently Patients have different expectations from treatment Many patients elect not to be treated

10 Lower Urinary Tract Function Storage of urine at low pressure to protect kidneys and assure continence Voluntary evacuation of urine Urodynamics - dynamic study of the transport, storage and evacuation of urine Comprised of a number of tests which individually or collectively can be used to gain information about urine storage and evacuation

11 Evaluation of LUT Dysfunction Urodynamics is only part of the evaluation Should be interpreted with regard to patient s history and symptoms *Exception NLUTD Urodynamic studies are not always required to evaluate urinary symptoms

12 Why Do UDS at All? In most cases LUTS, the decision to treat is determined by symptom bother not UDS findings UDS can help to determine which treatment, but usually not if treatment will be started Exceptions Advanced neurological disease Possible dangerous sequela of LUT dysfunction

13 Why Do UDS at All? Examples 63 year old man with urgency and occasional urgency incontinence, not responsive to conservative measures and meds for OAB and BPH, low normal Qmax, PVR = 75 ml 63 year old woman with mixed incontinence, PVR = 0, failed conservative therapy and OAB meds

14 A Different Story 38 old woman High grade incontinence insensible + urgency incontinence for years Many large pads/day Obese High grade SUI with no urethral mobility PVR = 0

15 The Rest of The Story 6 years s/p nephrectomy for right staghorn calculus Recent sepsis and left hydronephrosis (creatinine from 1.0 to 3.4) Foley placed, sepsis treated, creatinine normalized and hydronephrosis resolved Follow-up imaging showed recurrent left hydronephrosis with no point of obstruction identified

16 Leakage starts and persists SUI

17 The main goal of UDS is to reproduce the patient s symptoms when present and determine the cause of these symptoms by urodynamic measurements or observations Some conditions are associated with few or no symptoms, yet urodynamic testing may be appropriate

Clinical utility of UDS * 1. Identify factors contributing to LUT dysfunction and assess their relevance 2. Predict the consequences of LUT dysfunction on the upper tracts 3.

18 Clinical utility of UDS * 1. Identify factors contributing to LUT dysfunction and assess their relevance 2. Predict the consequences of LUT dysfunction on the upper tracts 3. Predict the consequences and outcomes of therapeutic intervention 4. Confirm and/or understand the effects of interventional techniques 5. Investigate the reasons for treatment failure *Hosker G, Rosier P, Gajewski J et al: Dynamic Testing. In: Incontinence 4th Edition 2009; 413.

19 UDS: Reproducibility Committee on Urodynamic Testing, Rosier P, et al. Physiologic variation ±10-15% for various parameters (volume, pressure or flow) and observations Various studies have demonstrated clinically relevant practice variation and inter-rater and observer variation Investigators and clinicians must take into account the inherent physiological variability of urodynamic testing

20 UDS: Reproducibility Committee on Urodynamic Testing, Rosier P, et al. Investigators and clinicians need to evaluate the representativity of the tests Evaluation based on the patient s perception as to how well the tests have reproduced their usual lower urinary tract symptoms and function, helped by other information (e.g. the voiding diary) Examiners should strive towards maximal representativity

21 Optimizing Urodynamics Decide on questions to be answered before starting the study Design the study to answer these questions Customize the study as necessary What is the information I need to obtain from UDS and what is the most appropriate UDS technique to obtain these results?

22 Interpreting Urodynamics A study not duplicating symptoms when an abnormality is recorded is not diagnostic Not all abnormalities are clinically significant Failure to record an abnormality does not rule out its existence

23 Historical Perspective The bladder is an unreliable witness Patrick Bates The bladder is a lot more reliable then some urodynamic interpretations that I have seen V. Nitti The bladder may be unreliable, but is the patient?

24 Historical Perspective: The Literature When there is a mismatch between UDS and patient symptoms in a neurologically intact patient, the UDS has almost always taken as correct No level anything data to support this No data to support the converse either In such cases solid clinical judgment should prevail

25 Where We Know UDS Often Falls Short Detrusor overactivity Probably don t need UDS 30-50% of patients with UUI have a normal CMG DO does not predict response to antimuscarinics, onabotulinumtoxina, or SNM in patients with UUI VUDS more reliable EMG or at least surface EMG often unreliable Diagnosis of BOO in men in the face of impaired contractility Can be done with clinical interpretation BOO defined by high pressure

26 Difficulties with EMG Surface EMG electrodes are prone to artifacts, causing apparent increased activity during voiding Needle EMG, while more accurate is uncomfortable, and many patients are adverse to its use Measurement of external sphincter and pelvic floor activity is critical to the diagnosis of functional obstruction esp. in young men and in women

Urology 2012; 80: 55-60 EMG alone would have given the wrong diagnosis in 20.6% of those with DV (false negative) and 14.

27 Urology 2012; 80: EMG alone would have given the wrong diagnosis in 20.6% of those with DV (false negative) and 14.3% of those with PBNO (false positive) In neurologically intact women with the diagnosis of BOO, EMG had a sensitivity of 79% and specificity of 85% to diagnose DV when videourodynamics was used as the standard When fluoroscopy is used to define these entities, the accuracy of EMG to differentiate them is questionable

28 37 year old healthy woman with unexplained urinary retention DO DO Void Void ICS 2011 workshop 17B

29 ICS Nomogram Bladder Outlet Obstruction Index BOOI = PdetQmax - 2*Qmax Cannot definitively diagnose obstruction when Pdet < 40 cm H20 Cannot diagnose obstruction at all when Pdet < 20 cmh2o BOOI > 40 = obstructed BOOI equivocal BOOI < 20 = unobstructed Griffiths et al Neurourol Urodyn 1997;16:1

30 UDS Mismatch : Two Common Scenarios 1. UDS does not provide all (or any) of the information that we needed What to do with the non-diagnostic study 2. Complete UDS and symptom mismatch Do we believe the patient or the study? Can we reconcile the differences?

31 85 year old woman with incontinence and very large residual after hospitalization for a fall injury ICS 2011 workshop 17B

32 85 year old woman with incontinence and very large residual after hospitalization for a fall injury `` Usual symptoms recreated Diagnostic Study Dx: Detrusor overactivity plus Detrusor underactivity IDC s with leaks ICS 2011 workshop 17B

33 Healthy 26 year old female with no neurologic history Urinary retention diagnosed as an elevated PVR with a UTI 4 years prior On CIC, urges to void with occasional flow with full bladder Attempt to void Urge to void and flow not duplicated on study Non-Diagnostic study ICS 2011 workshop 17B

34 Study repeated 10 days later Attempt to void Urge to void and flow duplicated on this study Sustained contraction > 3 minutes ICS 2011 workshop 17B

35 45 Year Old Woman Chief Complaint: Urinary frequency & incontinence Longstanding history of progressive symptoms: Frequency: 4-5 times per hour (despite fluid restriction) Nocturia: 1-2 times per night Urgency Urgency incontinence Mild stress incontinence: cough, sneeze, laughing and seated to standing position Usually no difficulties voiding, good force of stream Sometimes strains to fully empty Failed behavioral therapy and anticholinergic

36 45 Year Old Woman PMH: anxiety disorder Ob/Gyn history G2P0 Recurrent herpes simplex virus Meds valacyclovir, trazadone, clonazepam, rosuvastatin Physical Exam: Abd exam normal Well estrogenized Mild hypermobility No SUI Strong pelvic floor contraction No significant POP PVR = 11 ml

37 Qmax = 6 ml/s PdetQmax = 32 cmh20 Meets criteria for BOO by Blaivas Groutz, Cut Points and VUDS Criteria Void Void Second fill SIDO with UUI SIDO with UI 58 ml 135 ml SIDO with UI 109 ml EMG patch dislodged

38 Further Evaluation Non-invasive uroflow Normal pattern, Mimics real-life but much different then UDS Final Diagnosis: Stress induced DO No voiding phase dysfunction Cystoscopy Urethra normal, no stricture Bladder trabeculated

39 Two Similar Cases What s the Difference?

40 62 Year Old Woman Mixed incontinence Unable to tell if stress or urge is worse Significant insensible incontinence Physical exam shows urethral hypermobility and significant SUI Normal emptying PVR = 0

41 62 Year Old Woman With Mixed Incontinence Based on this study + history would recommend SUI surgery DI 75 ml 100 ml 135 ml 200 ml 275 ml ALPP ALPP ALPP DOI DOI

42 71 Year Old Woman Chief complaint: Urgency and UUI Voids 2x/hour No SUI, never loss of urine without urge Treated with multiple meds no help 100 then 200 units OnabotulinumtoxinA 3 and 6 months prior some improvement but short lived UDS post BTx (outside) showed SUI and intrinsic sphincter deficiency no DO and mid urethral sling suggested At end of the study the patient stood up and after coughing she leaked out all of the volume in her bladder

43 71 Year Old Woman Summary of Symptoms Frequency: Void 10+ times a day Nocturia: 5 times per night Nocturnal enuresis Urgency Urge Incontinence: Daily multiple times. No SUI 3 pads per day, another 3-4 at night Confirmed on a diary

44 71 Year Old Woman With Urgency Incontinence Based on this study + history would recommend neuromodulation ALPP DOI DOI

45 Two Similar Cases What s the Difference? THE HISTORY!

46 Urodynamics Mismatch Recommendations for Believing the Study Urodynamics shows a potentially dangerous condition that if left untreated or treated incorrectly could result in harm to the patient If a dangerous UDS parameter is uncovered it should almost always be treated

47 Urodynamics Mismatch Recommendations for Believing the Patient The symptoms and UDS findings are not dangerous and treatment (or no treatment) based on symptoms rather than UDS will not result in harm to the patient Choose most conservative treatment first That is usually the one based on symptoms and not UDS Ability to change treatment according to response Usually DOES NOT apply to cases of advanced NLUTD, impaired compliance, etc.

48 57 Year Old Male 3 years s/p RALP NED 25+ year history of MS On Betaseron for 19 years Ambulatory with cane Bothersome urinary incontinence 2-3 pads/day Going from the sitting to standing position Bending and doing other activities Denies any urgency incontinence

49 57 Year Old Male Physical exam no SUI PVR = 0 24 hour pad test x 4 = grams

50 57 Year Old Male Low Pressure DO with complete bladder emptying Complete UDS Mismatch but Patient has MS No SUI with/without catheter

51 57 Year Old Male: Treatment Outcome Started on fesoterodine 8 mg/day no help Added mirabegron 50 mg/day no help No change in symptoms or pad weight Reexamined patient during knee bends - + SUI Patient opted for sling

52 57 Year Old Man: Treatment Outcome Post op no SUI, + UUI 24 hour pad test = 78 gm. Restarted on fesoterodine improved Pad weight = 30 gm. Stayed on fesoterodine for 1.5 years with variable success for UUI, no SUI Would like to be better

53 57 Year Old Man: Treatment Outcome 100 units of Botox repeated again in 10 months Essentially dry with occasional bout of UUI not daily Not really a total mismatch after all

54 Clinical Utility of UDS 1. Identify factors contributing to LUT dysfunction and assess their relevance Make sure that it is actually useful to identify such factors 2. Predict the consequences of LUT dysfunction on the upper tracts Critical in appropriate clinical scenario 3. Predict the consequences and outcomes of therapeutic intervention Realize limitations here - sometimes it does and sometimes it does not 4. Confirm and/or understand the effects of interventional techniques Make sure this is really necessary e.g. NLUTD 5. Investigate the reasons for treatment failure Very appropriate recognize limitations

55 UDS is Most Valuable When The reasons for the study are well thought out with specific questions to be answered The limitations of the study are well understood The finding correlate with symptoms or at least make sense based on the clinical scenario

56 Challenging Dogma

57 85 year old woman in urinary retention: obstruction or detrusor underactivity? History: Urinary retention after excision of distal urethral lesion On CIC for 2 years pves pabd pdet Sustained detrusor contraction pdet max = 15cmH 2 O

58 Videourodynamic Criteria For BOO Nitti, et al: J Urol 1999; 161: Retrospective review of 261 VUDS studies Obstruction defined as radiographic evidence of obstruction between the bladder neck and distal urethra in the presence of a sustained detrusor contraction of any magnitude Usually results in decreased or delayed flow No strict pressure / flow criteria used Simultaneous fluoroscopy also localizes the obstruction helping to make a specific diagnosis

59 Videourodynamic Criteria For BOO Nitti, et al: J Urol 1999; 161:

60 Causes of Obstruction Nitti, et al J Urol 1999; 161:

61 Videourodynamic Criteria For BOO Nitti, et al: J Urol 1999; 161: Statistically significant difference in UDS parameters in obstructed and unobstructed women, but values not of magnitude seen in men Large overlap Because of the wide variation of voiding pressure and flow parameters in obstructed and unobstructed women, the diagnosis of BOO is difficult to make using these parameters alone

62 BOO In Women Three Contemporary Series Cut Points Chassagne, et al: Urology 1998; 51: Lemack and Zimmern: J Urol 2000; 163: Defreitas, et al: Urology 2004; 64: Nitti, et al: J Urology 1999; 161: Blaivas & Groutz: Neurourol Urodyn 2000; 19:553-64

63 Voiding Phase Dysfunction in Women Because pressure/flow parameters for obstruction and impaired contractility in females are not universal (and may never be because of the multitude of conditions that cause the problems) diagnosis must be made based on a number of factors including: history, physical exam, frequency/ volume diaries, non-invasive testing, UDS and imaging An individualized approach to diagnosis and treatment appears to be optimal We talked mostly about obstruction because that is the one entity that we can treat!!

64 Neurourology and Urodynamics. 2017;9999: Retrospective review of VUDS and clinical data of 535 women using VUDS criteria or obstruction. Cluster analysis was performed on the data from 185 women (original cohort) to derive an axis that best divides the definitively obstructed and unobstructed. The sensitivity and specificity of the derived criterion was then tested by applying it to a further 350 women (validation cohort) Binary logistic regression analysis was then applied to the total dataset to derive a female BOO nomogram with a color map representing the likelihood of BOO for a combination of PdetQmax and Qmax measurements

65 Neurourology and Urodynamics. 2017;9999:

66 Probability of BOO based on combos of pdetqmax & Qmax Decision boundary P=0.5 is PdetQmax= 2.2xQmax +5 BOOIf = 2.2xQmax+5 BOOIf <0 - <10% probability of BOO BOOIf >5-50% probability of BOO BOOIf >18 - >90% probability of BOO

67 Neurourology and Urodynamics. 2017;9999:

68 Neurourology and Urodynamics. 2017;9999:

69 Final Thoughts on UDS UDS is a supplement to the clinical decision making process It is only useful in conjunction with good clinical judgment Use your brain, not just your eyes

70 Final Thoughts for the Residents and Fellows It is a privilege to do what we do Find something that interests you and run with it Learning does not stop when you finish training it is an everyday process Don t forget to think

Tools for Evaluation. Urodynamics Case Studies. Case 1. Evaluation. Case 1. Bladder Diary SUI 19/01/2018

Tools for Evaluation. Urodynamics Case Studies. Case 1. Evaluation. Case 1. Bladder Diary SUI 19/01/2018 Urodynamics Case Studies Christopher K. Payne, MD Vista Urology & Pelvic Pain Partners Emeritus Professor of Urology, Stanford University Tools for Evaluation Ears, Eyes, and Brain Bladder diary Stress