In the last few years, the role of urodynamic tests in the preoperative evaluation of female urinary incontinence has been debated. Urodynamic investigation (UDI) in the recent past was considered mandatory before surgery in all female patients affected by stress urinary incontinence (SUI), according to several guidelines or recommendations (1,2). Nevertheless, a clear demonstration of an improvement of outcomes or change of clinical strategy after UDI was lacking.
The scenario changed in 2012 after the publication of the ValUE trial (3) and two papers from van Leijsen et al (4,5) aimed to evaluate whether or not UDI may somehow improve objective and subjective surgical outcomes in the treatment of SUI. Those trials labeled UDI useless since postsurgical outcomes of women who had not been UDI studied were comparable to those registered for patients who had UDI in their preoperative workup. However, it should be underlined, as correctly done by the Authors, that all these trials enrolled exclusively women with pure SUI or mixed incontinence with prevalent SUI, according to strict inclusion and exclusion criteria. Those patients had been classified as having an “uncomplicated” demonstrable SUI, in the ValUE trial (3).
As a consequence, the contemporary guidelines (6,7) are more cautious on the role of preoperative UDI.
A recent Cochrane systematic review by Clement et al (8) evaluated the present literature with the aim of analyzing if pre-operative UDI does improve the clinical outcomes or does the use of pre-operative UDI alter clinical decision-making. The authors concluded that while urodynamics may change clinical decision-making, there is “some high-quality evidence that this did not result in lower urinary incontinence rates after treatment” (8). This systematic review included few papers and the majority of the patients analyzed came from the ValUE study (3).
Thus, the message that could be received is that UDI before surgery for stress incontinence is without purpose in all patients (uncomplicated and complicated). This conclusion is unjustified considering that the uncomplicated/simple patients are the minority of the patients as it has been several times demonstrated.
In the present study, collecting data from several referral centers in Italy, we were able to show that only 36% of more 2053 patients could have been diagnosed as having an “uncomplicated” SUI, according to ValUE trial criteria. Furthermore, preoperative UDI led to the diagnosis of different type of urinary incontinence in 74.6% of complicated vs. 40% of uncomplicated SUI cases (P = 0.0001). A voiding dysfunction on UDI was observed in 13.4% of the uncomplicated cases and in 22.5% of the complicated cases (P = 0.0001).
In our opinion, some important information come from this study: first the so-called “uncomplicated” SUI patients are a minority of patients. In the ValUE trial the majority of the screened patients (more than 60%) had been excluded from the study because they did not fit the inclusion/exclusion criteria (3). This result confirms the observation coming from our study, in which 64% of patients were considered “complicated”, using the ValUE trial criteria. A second consideration emerging from our study is that in the majority of “complicated” patients the urodynamic observation varies from the pre-urodynamic diagnosis much more frequently than in the “uncomplicated” patients. In a sub analysis of the ValUE trial (10), Sirls et al showed that UDI was able to add some data to the pre-urodynamic information, but that this new information changed the following surgical management only in about 7% of patients. In our study, the following surgical management was changed in a comparable percentage of “uncomplicated” SUI patients (11%), but in a much higher percentage of the “complicated” ones (23.8%). Thus, it is possible to suppose that UDI effectively changes the surgical management of one quarter of “complicated” patients, and possibly in a 20% of the total patients’ population.
Actually, a tailored treatment is an essential target to obtain. UDI may prevent surgical intervention in women without USI or with prevalent detrusor overactivity incontinence (10). Furthermore, some urodynamic variables could guide the choice of surgery (e.g., trans-obturator vs. retropubic mid-urethral sling). They may also identify patients at risk of failure and at risk of the development of postoperative urgency, urgency incontinence and voiding dysfunction. This accurate assessment of the risks and benefits of surgery is fundamental to facilitate a correct preoperative counseling, directed towards appropriate patient expectations, as well as guide the proactive management of postoperative symptoms (10).
In conclusion, we believe that in the majority of patients (the “complicated” ones) the role of UDI has not been fully evaluated. Nevertheless, data coming from literature and from daily clinical practice show that UDI may provide valuable data to evaluate the best clinical strategy. In uncomplicated cases, pretreatment UDI is probably not mandatory but it could give important information (voiding dysfunction in about 10% of cases may be diagnosed only after UDI, according to the ValUE trial, 3) offering a valuable guide to the surgeon and to the patient. “Primum non nocere” (First, do not harm) is one of the principal precepts of bioethics. A careful patient assessment is required to avoid a negligent practice. Urodynamic investigations is a valuable tool able to help us in counseling our patients with the aim of cure their symptoms, never risking of worsening them or causing further discomfort.
References:
1. Thüroff JW, Abrams P, Andersson KE, Artibani W, Chapple CR, Drake MJ, Hampel C, Neisius A, Schröder A, Tubaro A. EAU guidelines on urinary incontinence. Eur Urol 2011; 59: 387-400 [PMID: 21130559 DOI: 10.1016/j.eururo.2010.11.021]
2. Ghoniem G, Stanford E, Kenton K, Achtari C, Goldberg R, Mascarenhas T, Parekh M, Tamussino K, Tosson S, Lose G, Petri E. Evaluation and outcome measures in the treatment of female urinary stress incontinence: International Urogynecological Association (IUGA) guidelines for research and clinical practice. Int Urogynecol J Pelvic Floor Dysfunct 2008; 19: 5-33 [PMID: 18026681 DOI: 10.1007/s00192-007-0495-5]
3. Nager CW, Brubaker L, Litman HJ, Zyczynski HM, Varner RE, Amundsen C, Sirls LT, Norton PA, Arisco AM, Chai TC, Zimmern P, Barber MD, Dandreo KJ, Menefee SA, Kenton K, Lowder J, Richter HE, Khandwala S, Nygaard I, Kraus SR, Johnson HW, Lemack GE, Mihova M, Albo ME, Mueller E, Sutkin G, Wilson TS, Hsu Y, Rozanski TA, Rickey LM, Rahn D, Tennstedt S, Kusek JW, Gormley EA. A randomized trial of urodynamic testing before stress-incontinence surgery. N Engl J Med 2012; 366: 1987-1997 [PMID: 22551104 DOI: 10.1056/NEJMoa1113595]
4. van Leijsen SA, Kluivers KB, Mol BW, Broekhuis SR, Milani AL, Bongers MY, Aalders CI, Dietz V, Malmberg GG, Vierhout ME, Heesakkers JP. Can preoperative urodynamic investigation be omitted in women with stress urinary incontinence? A non-inferiority randomized controlled trial. Neurourol Urodyn 2012; 31: 1118-1123 [PMID: 22488817 DOI: 10.1002/nau.22230]
5. van Leijsen SA, Kluivers KB, Mol BW, Hout Ji, Milani AL, Roovers JP, Boon Jd, van der Vaart CH, Langen PH, Hartog FE, Dietz V, Tiersma ES, Hovius MC, Bongers MY, Spaans W, Heesakkers JP, Vierhout ME. Value of urodynamics before stress urinary incontinence surgery: a randomized controlled trial. Obstet Gynecol 2013; 121: 999-1008 [PMID: 23635736 DOI: 10.1097/AOG.0b013e31828c68e3]
6. Lucas MG, Bosch RJ, Burkhard FC, Cruz F, Madden TB, Nambiar AK, Neisius A, de Ridder DJ, Tubaro A, Turner WH, Pickard RS. EAU guidelines on surgical treatment of urinary incontinence. Eur Urol 2012; 62: 1118-1129 [PMID: 23040204 DOI: 10.1016/j.eururo.2012.09.023]
7. Abrams P, Cardozo L, Khoury S, Wein A. Incontinence. Fifth International Consultation on Incontinence, ICUD. Paris Feb, 2012
8. Clement KD, Lapitan MC, Omar MI, Glazener CM. Urodynamic studies for management of urinary incontinence in children and adults: A short version Cochrane systematic review and meta-analysis. Neurourol Urodyn 2015; 34: 407-412 [PMID: 24853652 DOI: 10.1002/nau.22584]
9. Sirls LT, Richter HE, Litman HJ, Kenton K, Lemack GE, Lukacz ES, Kraus SR, Goldman HB, Weidner A, Rickey L, Norton P, Zyczynski HM, Kusek JW. The effect of urodynamic testing on clinical diagnosis, treatment plan and outcomes in women undergoing stress urinary incontinence surgery. J Urol 2013; 189: 204-209 [PMID: 22982425 DOI: 10.1016/j.juro.2012.09.050]
10. Serati M, Cattoni E, Siesto G, Braga A, Sorice P, Cantaluppi S, Cromi A, Ghezzi F, Vitobello D, Bolis P, Salvatore S. Urodynamic evaluation: can it prevent the need for surgical intervention in women with apparent pure stress urinary incontinence? BJU Int 2013; 112: E344-E350 [PMID: 23421421 DOI: 10.1111/bju.12007]
11. Giarenis I, Cardozo L. What is the value of urodynamic studies before stress incontinence surgery? BJOG 2013; 120: 130-132 [PMID: 23240793 DOI: 10.1111/1471-0528.12102]
Written by:
Enrico Finazzi-Agrò, MD
Associate Professor of Urology
President of the Italian Society of Urodynamics (SIUD).