IVES Improves Clinical Outcomes and Quality of Life in Women with Idiopathic Refractory OAB Regardless of Treatment Frequency

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6 Sep, 22

Introduction

Along with medical therapies, conservative therapeutic options for the treatment of overactive bladder (OAB) and urgency urinary incontinence (UUI) have been in use. Intravaginal electrical stimulation (IVES) is one of the conservative treatment options which might improve the urinary incontinence (UI) as compared to the sham treatment in adults with UI. However, the duration of IVES therapies varies from 4 weeks to 6 months in women with idiopathic overactive bladder (OAB) and hence there are no studies comparing the different treatment frequencies of IVES in women with idiopathic OAB.

Aim

This study compares the efficacy of IVES therapies with different treatment frequencies (two or five days in a week) added to bladder training (BT) with respect to incontinence-related quality of life (QoL) and clinical parameters in women with refractory idiopathic OAB.

Method

Study Design

  • Prospective randomized trial

Patient Profile

  • Women >18 years with confirmed diagnosis of idiopathic OAB
  • Intolerant or unresponsive to antimuscarinics and discontinued atleast 4 weeks before enrollment

Treatment Strategy

  • Out of the 74 women with refractory idiopathic OAB, 52 were eligible and recruited in this study.
  • They were randomized into two groups of 26 each as follows:
    • Group 1 received BT and IVES, two times in a week, for 10 weeks
    • Group 2 received BT and IVES five times in a week, for 4 weeks
  • A total of 20 IVES sessions was performed by experienced urogynecological rehabilitation nurse for 20 minutes in a day for both the groups.
  • The participants filled in a 1-day bladder diary once every 5 sessions.
  • Women were evaluated for incontinence severity (24h pad test), pelvic floor muscles strength (perineometer), 3-day voiding diary (frequency of voiding, nocturia, incontinence episodes, and the number of pads), symptom severity (OAB-V8), quality of life (IIQ-7), treatment success (positive response rate), cure/improvement rate and treatment satisfaction (Likert scale).

Endpoints

Primary Endpoint

  • Positive response rate (>50% reduction in incontinence episodes)

Secondary Endpoints

  • Incontinence severity assessed by 24-hour pad test
  • Pelvic floor muscle (PFM) strength
  • Frequency of voiding, nocturia, incontinence episodes and number of pads
  • Symptom severity evaluated by OAB-V8 questionnaire
  • Incontinence-related QoL using the IIQ-7 questionnaire
  • Cure and improvement rate
  • Treatment satisfaction using Likert scale

Results

  • Both the groups had comparable baseline characteristics.
  • Both the groups demonstrated significant differences in the severity of symptoms, PFM strength, frequency of voiding, nocturia, incontinence episodes, number of pads, severity of incontinence and QoL post 20 sessions as compared to baseline; p<0.05.
  • The differences in all the parameters post-treatment were similar in both the groups.
  • Treatment satisfaction scores were comparable in both groups; p>0.05.
  • The cure/improvement and positive response rates were not significantly different between two groups (p>0.05) as shown in Figure 1.
Figure 1. Positive response rate and cure/improvement rates

  • None of the women experienced any serious adverse event except temporary discomfort due to vaginal irritation which was reported by 2 women in each group.

Conclusion

  • Intravaginal electrical stimulation (IVES) along with bladder training (BT) improved the clinical parameters and incontinence-related quality-of-life irrespective of the treatment frequency in women with idiopathic refractory overactive bladder (OAB).
  • The clinical efficacy and patient satisfaction with IVES therapy twice a week or 5 times a week was comparable; nevertheless IVES 5 times per week reduced the treatment duration.

Int Braz J Urol. 2022 Jul-Aug; 48(4): 662–671.