Is the Addition of Vaginal Electrical Stimulation to Transcutaneous Tibial Nerve Electrical Stimulation More Effective for Overactive Bladder Treatment? a Randomized Controlled Trial - Beyond the Abstract

This randomized controlled trial with blind assessment enrolled 106 women aged 18 years or over between May 2017 and June 2018 and hypothesized the superiority of the group that associated the two electrostimulation techniques on the Overactive Bladder’s treatment.

The following assessments were applied before and after treatment:

  • King's Health Questionnaire (KHQ).
  • Overactive Bladder Questionnaire (OAB-V8).
  • Functional assessment of the pelvic floor conducted using the Ortiz scale
  • 3-day Voiding Diary
The primary outcome was urinary frequency and secondary outcomes were the other variables from the voiding diary, KHQ, OAB-V8, and functional evaluation of the pelvic floor muscles.

Procedure: After selecting the patients and checking the inclusion and exclusion criteria, participants were randomly divided into two groups according to a list generated using a computer program (randomization.com). Sealed envelopes were used for concealment. Randomization was performed by an assessor not involved in the assessment procedures. Group 1 (n = 52) received only TTNS and Group 2 (n = 54) received VS in addition to the treatment received by Group 1.

Interventions: All patients received instructions for behavior therapy and bladder training. Group 1 received TTNS, applied with the Dualpex 961 Quark® in continuous mode at a frequency of 10 Hz and a pulse width of 200 μs for 30 min. Group 2 received the same TTNS treatment followed by VS. VS was performed at a frequency of 10 Hz and a pulse width of 1 ms for 20 min.

Results: There was a decrease in the urinary frequency in both groups. Group 2 showed significant improvement compared with Group 1, with a reduction of 1.5 micturitions per day (95% CI: −2.9 to −0.1); p=0,044). However, the percentage for the decrease in frequency was similar in both groups (Group 1: 24% (95% CI: −0.36 to −0.05) vs Group 2: 26% (95% CI: −0.48 to 0.0); p = 0.49). Therefore, despite statistical differences in the absolute values, the decrease was not clinically relevant because the standard for clinical relevance adopted in this study is a decrease of three urinations in 24 h. All of the secondary variables recorded in the bladder diary (urgency, nocturia, UUI, and SUI) decreased after treatment in both groups with no significant differences. After treatment, both groups showed improvements in the KHQ and OAB-V8 scores as well as in the pelvic floor muscle strength. Our results showed that both treatments improved QoL, symptom severity, and pelvic floor function in women with OAB or mixed urinary incontinence. Furthermore, the group that received VS with TTNS experienced 1.5 fewer micturitions per day. However, this improvement was not considered clinically significant. Based on the results presented, it can be concluded that the addition of VS to TTNS did not have superior effects on the clinical symptoms or the QoL of women with OAB. Furthermore, the adherence for Group 1 was greater than for Group 2, once it was less invasive.

A larger sample and longer follow-up are needed to better compare and validate the effects between the modalities.

Written by: Fernanda Bacchi Ambrosano Giarreta, Universidad de São Paulo, São Paulo, Brasil

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