RANDOMIZED CONTROL TRIAL OF PARASACRAL TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION FOR OVERACTIVE BLADDER IN OLDER WOMEN – PILOT STUDY

Alves A1, Lorena D2, Barbosa M2, Pereira L2, Araújo H2, Nascimento G2, Cunha S2, Silva L2, Sousa J3, Garcia P2, Matheus L2, Rett M2, Soares A2, Romão J2, Jacomo R4, Sousa J5

Research Type

Clinical

Abstract Category

Overactive Bladder

Abstract 153
E-Poster 1
Scientific Open Discussion ePoster Session 7
Wednesday 4th September 2019
12:45 - 12:50 (ePoster Station 9)
Exhibition Hall
Overactive Bladder Gerontology Clinical Trial Neuromodulation Quality of Life (QoL)
1.UnB, 2.UnB - University of Brasilia, 3.UniCEUB, 4.HUB - University Hospital of Brasilia, 5.University of Brasilia - UnB
Presenter
S

Sarah Mendes da Cunha

Links

Poster

Abstract

Hypothesis / aims of study
Inherent modifications to the aging process might be related to an increase in the prevalence of overactive bladder (OAB) in older women (1). As a treatment proposal, it is found in literature, the behavioral therapy (BT), the medicines and the electrical stimulation (2). The transcutaneous parasacral electrical stimulation (TPS), which is used as a non-invasive alternative for the treatment of OAB, emphasizes positive results on the clinical condition and on the urodynamics variables studied, especially on children (3), and has the potential to produce similar effects on the elderly population. We conducted a pilot study with the aim of evaluating the effects of transcutaneous parasacral electrical stimulation on the urinary habits and quality of life (QoL) in older women with the OAB.
Study design, materials and methods
This is a pilot study randomized control trial in two groups, and a blind one. There were included on the study women with the age of 60 or more and with the OAB, which was identified using the score of 8 or more through the Overactive Bladder - version 8 questionnaire (OAB-V8). There were excluded the women who presented an inferior urinary tract infection, a history of medical or physiotherapeutic treatment for OAB in the last 6 months, base neurological diseases, a history of genitourinary neoplasia, previous pelvic irradiation, severe genital prolapse evaluated by the Baden-Walker scale and a cardiac pacemaker.  The urinary habits evaluation instruments and quality of life were: bladder diary (BD) of three days, the ICIQ-OAB (International Consultation on Incontinence Questionnaire Overactive Bladder) and the ICIQ-SF (International Consultation on Incontinence Questionnaire-Short Form). The treatment of group G1 consisted of two BT sessions, in which they received, through a lecture, an orientation regarding urinary habits. In the end, an educational booklet was given to fix the content. The patients were oriented regarding the sanitary positioning, programmed urination, programmed water intake and the avoidance of intaking irritative drinks and food. The G2 group received the same protocol of G1, added to the parasacral electrical stimulation, which was done in 8 sessions, twice a week, with a duration of 30 minutes each and an interval of 24 hours between them. A pair of silicon superficial electrodes were fixed on the posterior superior iliac spines on the transversal position. The parameters used for stimulation were: F= 10 Hz, T= 700 µs with the maximum intensity sustained by the patient. The final evaluation was done by the same physical therapist evaluator, being done in a period of 5 weeks after the beginning of treatment. For the normality analysis, it was used the Shapiro-Wilk test. The Mann-Whitney U test was used to analyze the homogeneity between groups and the before and after intergroup analysis. The Wilcoxon test evaluated the intergroup comparing analysis. It was considered a significance level of 0,05. To evaluate the testing power used on the study, it was applied a post hoc analysis which demonstrated the power of 0.80 with an effect size of 0.66.
Results
Results
37 eligible patients were selected for the study, by convenience. However, 16 participants were excluded from it due to: advanced prolapse (2), base neurological diseases (6), and previous treatment for OAB (8) with a total of 21 patients (G1= 11 and G2= 10). During the intervention period, 3 participants of G1 and G2 groups withdrew the treatment.
Interpretation of results
In G2 group it was observed a significant statistical improvement for the ICIQ-OAB score (p=0.018), the degree of the discomfort the frequency (p=0.042), nocturia (p=0.026), urgency (p=0.026) and the urgency urinary incontinence (p=0.039). There were not found significant statistical evidence in group G1 (Table 1).
Concluding message
The transcutaneous parasacral electrical stimulation presented a significant improvement for the variables related to the symptoms and to the degree of discomfort evaluated by ICIQ-OAB in older women with OAB.
Figure 1
References
  1. CHUANG, Y. C. et al. Prevalence of overactive bladder in China, Taiwan and South Korea: Results from a cross-sectional, population-based study. LUTS: Lower Urinary Tract Symptoms, v. 11, n. 1, p. 48–55, 2017.
  2. GORMLEY, E. A. et al. Diagnosis and treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU guideline amendment. Journal of Urology, v. 193, n. 5, p. 1572–1580, 2015.
  3. HOEBEKE, P. et al. Transcutaneous neuromodulation for the urge syndrome in children: A pilot study. Journal of Urology, v. 166, n. 6, p. 2416–2419, 2001.
Disclosures
Funding None Clinical Trial Yes Registration Number RBR-9q7j7y RCT Yes Subjects Human Ethics Committee Ethics Committee of UNB Medicine Department; Number: 1.845.593 Helsinki Yes Informed Consent Yes