Transcutaneous electrical tibial nerve stimulation in treatment of overactive bladder syndrome in older women – randomized controlled clinical trial

Barbosa M1, Alves A1, Ayres D1, De Araújo H1, Pereira L1, Rett M2, Pequeno S1, Souza N1, De Lima E1, Jácomo R3, Gomide Matheus L1, Salata M4, Garcia P1

Research Type

Clinical

Abstract Category

Overactive Bladder

Abstract 293
Overactive Bladder
Scientific Podium Short Oral Session 21
Friday 9th September 2022
11:45 - 11:52
Hall G1
Overactive Bladder Quality of Life (QoL) Physiotherapy Clinical Trial Neuromodulation
1. Universidade de Brasilia - UnB, 2. Universidade Federal de Sergipe - UFS, 3. Hospital Universitário de Brasilia - HUB, 4. Centro Universitário do Planalto Central - UNICEPLAC
Online
Presenter
Links

Abstract

Hypothesis / aims of study
Transcutaneous electrical tibial nerve stimulation (TTNS) is being studied for the management of Overactive Bladder Syndrome (OAB). It is a non-invasive, effective, safe, and tolerable treatment to reduce voiding symptoms in adults and the elderly with idiopathic and neurogenic OAB (1). Schreiner et al suggested the use of TTNS associated with behavioral therapy (BT) as a first-line intervention for the treatment of OAB symptoms in older women (2). The overactive bladder has a global prevalence in both sexes and tends to increase with advancing age, in addition, to having a negative impact on quality of life (QoL) (1). Among the treatment options, Guidelines (3) suggest, as a gold standard, initially, conservative treatment with behavioral therapy (BT), which includes bladder training, pelvic floor muscle training (PFM), and fluid intake control. Considering the prevalence and impact on QoL, in addition to the option of non-invasive treatments and vaginal manipulation in this population, further research is needed regarding TTNS in elderly women as a safe and tolerable form of treatment, non-medicated, with the use of superficial electrodes to reduce the symptoms of OAB. Therefore, the objective of this study was to evaluate the effects of transcutaneous electrical tibial nerve stimulation associated with behavioral therapy in the treatment of OAB in older women, comparing the effects of exclusive behavioral therapy, a treatment recommended as the first line by the Guidelines in adults.
Study design, materials and methods
A randomized controlled clinical trial was conducted with a blinded evaluator and a comparison between control and intervention groups. The sample was selected for convenience and the screening of patients was performed through the indication of doctors, and partner groups and the dissemination of the service in groups of older women in the city. The inclusion criteria were female gender, age between 60 and 80 years, with the presence of urinary dysfunction identified by the score greater than or equal to 8 points in the OAB-V8 (Overactive Bladder Awareness Tool) questionnaire. Were excluded women with lower urinary tract infection, identified by a urine test, history of treatment for OAB in the last 6 months, baseline neurological diseases, history of genitourinary neoplasia, previous pelvic irradiation, genital prolapse that exceeds the vaginal ostium, cardiac pacemaker, or use of medicine for OAB. The analyzed variables of the study were symptoms and degree of discomfort of the OAB through the ICIQ-OAB (International Consultation on Incontinence Questionnaire Overactive Bladder). The treatment of the G1 consisted of 2 sessions of BT, which were passed orientations concerning the proper positioning for urination, always seated, with legs apart, trunk forward, elbows supported on the knees, and use of foot support to maintain greater hip flexion; programmed urination, patients should try to postpone the urination to the maximum, trying to reach an interval of 2 hours; avoid the ingestion of liquid 2 hours before bedtime to avoid episodes of nocturia and avoid the consumption of irritants food and beverages to the bladder. The G2 performed 8 sessions (2x per week) of TTNS associated with 2 sessions of BT. The following parameters were fixed for electrical nerve stimulation F = 10 Hz, T = 200 µs, t = 30 min, and maximum intensity tolerated by the patient. The sample size calculation was performed from a pilot study with 19 participants (8 in G1 and 11 in G2), using the G-Power 3.1.9.2 program, with a significance level of 5% and an error of 20%. Based on the main outcome of the impact of OAB symptoms in QoL, a sample size of 17 participants was obtained in each group. Data analysis was performed using SPSS 26 software. Data normality was verified using the Shapiro-Wilk test. The comparison of OAB symptoms before and after the intragroup intervention was analyzed using the Wilcoxon test and the analysis between the groups was using the Mann-Whitney U test. The significance level adopted was 5% (p < 0,05). Intention-to-treat analysis was performed to preserve randomization. To evaluate the power of the test used in the study was applied the post hoc analysis demonstrated power of 0.94 with an effect size of 0.81.
Results
Were considered eligible for the study, 75 older women with OAB. After the initial interview, 37 patients were excluded by: of neurological disease (12), lower urinary tract infection (1), previous pelvic irradiation (1), cardiac pacemaker (1), severe genital prolapse (8), history of physiotherapeutic treatment for OAB (7) and drug treatment for OAB (7). Thus, 38 patients were randomized to compose the final study sample, 19 in G1 (BT) and 19 in G2 (BT+TTNS).
Interpretation of results
Both groups were homogeneous for the characteristics and clinical complaints analyzed pre-treatment. In the intragroup comparison, there was a significant improvement in QoL in both groups (G1 - BT and G2 - BT+TTNS). Group 1 (BT) also showed a significant reduction in the discomfort of urgeincontinence and nocturia symptoms. In G2 (BT+TTNS), only the daytime frequency variable showed no significant reduction evaluated by the ICIQ-OAB. No significant differences were found in the analysis between groups (Table I).
Concluding message
If we consider the reduction in the discomfort of OAB symptoms, other than the discomfort daytime urinary frequency, evaluated by the ICIQ-OAB, transcutaneous electrical tibial nerve stimulation can be used as initial therapy associated with behavioral therapy in older women with overactive bladder. However, we emphasize that the aspects related to the improvement of quality of life, both combined therapy and isolated behavioral therapy were effective.
Figure 1 Table I - Comparison of quality of life and urinary symptom inter and intra-group (before and after intervention)
References
  1. Booth J, Connelly L, Dickson S, Duncan F, Lawrence M. The effectiveness of transcutaneous tibial nerve stimulation (TTNS) for adults with overactive bladder syndrome: A systematic review. Neurourol Urodyn. 2018 Feb;37(2):528–41.
  2. Schreiner L, Dos Santos TG, Knorst MR, Da Silva Filho IG. Randomized trial of transcutaneous tibial nerve stimulation to treat urge urinary incontinence in older women. Int Urogynecol J. 2010;21(9):1065–70.
  3. Gormley EA, Lightner DJ, Burgio KL, Chai TC, Clemens JQ, Culkin DJ, et al. Diagnosis and treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU guideline. J Urol. 2019;188(6 SUPPL.):2455–63.
Disclosures
Funding None Clinical Trial Yes Registration Number REBEC: RBR-9q7j7y RCT Yes Subjects Human Ethics Committee College of Medicine of University of Brasilia – UnB Helsinki Yes Informed Consent Yes
Citation

Continence 2S2 (2022) 100359
DOI: 10.1016/j.cont.2022.100359

15/10/2024 04:22:18