Randomized-controlled trial assessing the need for urodynamic evaluation in Multiple Sclerosis patients with lower urinary tract symptoms

EL HELOU E1, ZALAKET J1, MJAESS G1, MOUAWAD C1, SAYEGH N1, GHATTAS S1, EL HELOU J1, ABBOUD H1, NEMR E1, KOUSSA S1

Research Type

Clinical

Abstract Category

Neurourology

Abstract 71
E-Poster 1
Scientific Open Discussion ePoster Session 7
Wednesday 4th September 2019
12:55 - 13:00 (ePoster Station 1)
Exhibition Hall
Clinical Trial Multiple Sclerosis Prospective Study Urodynamics Techniques
1.Faculty of Medecine, Saint Joseph University, Beirut, Lebanon
Presenter
E

Elie El Helou

Links

Poster

Abstract

Hypothesis / aims of study
Lower urinary tract symptoms (LUTS) are a major clinical problem and a significant cause of disability in multiple sclerosis (MS) patients. The need for complete urodynamic evaluation in such patients is not fully established in the literature. Some authors recommend to limit the first evaluation in these patients to plasmatic creatinine levels, urinalysis and renal bladder ultrasound before treatment [1], while others recommend a complete urodynamic evaluation including cystomanometry, Pressure Flow Study (PFS), and electromyography (EMG), due to the heterogeneity of the presentations and the possible repercussion on the upper urinary tract [2]. The aim of this study was to evaluate the effect of urodynamic evaluation in patients with MS and LUTS on treatment outcomes (symptoms, bother, and urologic quality of life).
Study design, materials and methods
This is an IRB-approved randomized-controlled trial. Patients with MS and LUTS were recruited and had 2 visits to our center. On the first visit, preliminary baseline demographics and disease characteristics were assessed including age, sex, BMI, Expanded disability Status Scale EDSS, duration of both MS and LUTS, type of MS (relapsing remitting RR, primary progressive PP, or secondary progressive SP), MS treatment, previous urological follow-up, and anterior urological treatment. Moreover, evaluation of symptoms using the OverActive Bladder Symptom Score (OABSS) and the voiding sub-score of the International Prostate Symptom Score (IPSS-V), bother caused by these symptoms using Urinary Bothersome Questionnaire in Multiple Sclerosis for voiding (UBQMS-V) and filling (UBQMS-F), and urologic quality of life using SF-QUALIVEEN [3], were evaluated. Patients also had urinalysis with urine culture, plasmatic creatinine level, and renal bladder ultrasound. On the second visit, patients were randomized in 2 groups: group A who underwent uroflowmetry, and group B who underwent uroflowmetry, cystomanometry, pressure flow study (PFS), and electromyography (EMG). After the diagnosis, a treatment was given to each patient based on the whole evaluation. The same physician was responsible of the interpretation of the urodynamic evaluation, making the diagnosis, and deciding about the treatment. Patients were then blindly phone called on the first, third and sixth months following treatment in order to evaluate their adherence to treatment, and any change in their urinary symptoms, bother, or urologic quality of life. These results were compared between the two groups before and after the initiation of treatment, using Mann Whitney’s test and Mood’s median test followed by a comparison of the results before and after the initiation of treatment independently of group using Wilcoxon’s test.
Results
46 patients were enrolled in the study and randomized to 23 patients in group A and 23 patients in group B. No significant inter-group differences (p>0.05) were found for age (A:41y vs. B: 44y), sex ratio (A:1.3 vs. B:0.53), BMI (A:24.4 kg/m2 vs. B:25.9 kg/m2) , duration of MS (A:11y vs. B:7y), duration of LUTS (A:3y vs. B: 5y), mean EDSS score (A:4 vs. B:4), type of MS (A:59%RR,22%PP vs. B:56%RR,26%PP), MS treatment (A:90% vs. B:83%), previous urological follow-up (A:14% vs. B:38%), and anterior urological treatment (A:27% vs. B:30%). No significant differences were found between the two groups respectively before the treatment and after the 6 month-follow up (p>0.05) for symptoms (OABSS and IPSS-V), bother (UBQMS-V and UBQMS-R), and urologic quality of life (SF-QUALIVEEN) (Fig.1). When comparing these scores before and after treatment independently of the group, significant improvement in all scores (p<0.05) was noted (Fig.2). No significant inter-group differences were found for the adherence to treatment (p>0.05) (A:61% vs. B:81%).
Interpretation of results
Conducting a whole urodynamic evaluation including cystomanometry, PFS, and EMG in addition to renal bladder ultrasound and uroflowmetry, did not influence treatment outcomes (symptoms severity, bother, and urologic quality of life), nor adherence to treatment, in patients of the group B. However, the treatment was effective in both groups in accomplishing its outcomes since the difference between before and after the treatment independently of groups was significant. 
These results should not be extrapolated to patients with renal failure or upper tract dilatation as in our study population we had only 2 patients with upper tract dilatation and no cases of renal failure.
Concluding message
A detailed history taking with non invasive evaluation of MS patients with LUTS seems to be sufficient for prescribing an effective treatment. Adding a complete urodynamic study does not seem to influence the response to the prescribed treatment in terms of LUTS severity, bother and urologic quality of life nor does it affect the adherence to the suggested treatment.
Figure 1 Intergroup differences before and after treatment for symptoms, bother and urologic quality of life
Figure 2 Differences before and after treatment for symptoms, bother and urologic quality of life for the whole study population
References
  1. Amarenco et al. First-line urological evaluation in multiple sclerosis: validation of a specific decision-making algorithm. Mult. Scler. 2013
  2. Dillon et al. Urodynamics in the evaluation of the patient with multiple sclerosis: when are they helpful and how do we use them? Urol Clin North Am. 2014
  3. Bonniaud et al. Development and validation of the short form of a urinary quality of life questionnaire: SF-Qualiveen. J Urol. 2008
Disclosures
Funding Saint joseph university, Beirut, Lebanon Clinical Trial Yes Registration Number ClinicalTrials.gov NCT03336424 RCT Yes Subjects Human Ethics Committee Comite d'ethique de l'universite saint joseph Helsinki Yes Informed Consent Yes