Hypnotherapy or medications: a randomized noninferiority trial in urgency urinary incontinent women

Abstract

Background: Urgency urinary incontinence afflicts many adults, and most commonly affects women. Medications, a standard treatment, may be poorly tolerated, with poor adherence. This warrants investigation of alternative interventions. Mind-body therapies such as hypnotherapy may offer additional treatment options for individuals with urgency urinary incontinence.

Objective: To evaluate hypnotherapy's efficacy compared to medications in treating women with urgency urinary incontinence.

Materials and methods: This investigator-masked, noninferiority trial compared hypnotherapy to medications at an academic center in the southwestern United States, and randomized women with non-neurogenic urgency urinary incontinence to weekly hypnotherapy sessions for 2 months (and continued self-hypnosis thereafter) or to medication and weekly counseling for 2 months (and medication alone thereafter). The primary outcome was the between-group comparison of percent change in urgency incontinence on a 3-day bladder diary at 2 months. Important secondary outcomes were between-group comparisons of percent change in urgency incontinence at 6 and 12 months. Outcomes were analyzed based on noninferiority margins of 5% for between group differences (P < 0.025) (that is, for between group difference in percentage change in urgency incontinence, if the lower bound of the 95% confidence interval was greater than -5%, noninferiority would be proved).

Results: A total of 152 women were randomized to treatment between April 2013 and October 2016. Of these women, 142 (70 hypnotherapy, 72 medications) had 3-day diary information at 2 months and were included in the primary outcome analysis. Secondary outcomes were analyzed for women with diary data at the 6-month and then 12-month time points (138 women [67 hypnotherapy, 71 medications] at 6 months, 140 women [69 hypnotherapy, 71 medications] at 12 months. There were no differences between groups' urgency incontinence episodes at baseline: median (quartile 1, quartile 3) for hypnotherapy was 8 (4, 14) and medication was 7 (4, 11) (P = .165). For the primary outcome, although both interventions showed improvement, hypnotherapy did not prove noninferior to medication at 2 months. Hypnotherapy's median percent improvement was 73.0% (95% confidence interval, 60.0-88˖9%), whereas medication's improvement was 88.6% (95% confidence interval, 78.6-100.0%). The median difference in percent change between groups was 0% (95% confidence interval, -16.7% to 0.0%); because the lower margin of the confidence interval did not meet the predetermined noninferiority margin of greater than -5%, hypnotherapy did not prove noninferior to medication. In contrast, hypnotherapy was noninferior to medication for the secondary outcomes at 6 months (hypnotherapy, 85.7% improvement, 95% confidence interval, 75.0-100%; medications, 83.3% improvement, 95% confidence interval, 64.7-100%; median difference in percent change between groups of 0%, 95% confidence interval, 0.0-6.7%) and 12 months (hypnotherapy, 85.7% improvement, 95% confidence interval, 66.7-94.4%; medications, 80% improvement, 95% confidence interval, 54.5-100%; median difference in percent change between groups of 0%, 95% confidence interval, -4.2% to -9.5%).

Conclusion: Both hypnotherapy and medications were associated with substantially improved urgency urinary incontinence at all follow-up. The study did not prove the noninferiority of hypnotherapy compared to medications at 2 months, the study's primary outcome. Hypnotherapy proved noninferior to medications at longer-term follow-up of 6 and 12 months. Hypnotherapy is a promising, alternative treatment for women with UUI.

Trial registration: ClinicalTrials.gov NCT01829425.

Keywords: hypnotherapy; mind-body therapy; pharmacotherapy; randomized trial in women; urgency urinary incontinence.

Copyright © 2019 Elsevier Inc. All rights reserved.

Figures

Appendix Figure 1.. Differences in Hypnotherapy versus Pharmacotherapy at 2, 6 & 12 months

Error bars indicate 95% Confidence Intervals. Dashed line indicates the non-inferiority margin. Treatments whose error bars lie wholly to the right of the dashed line, within the blue tinted area, are non-inferior. Only treatments whose error bars are wholly to the right of the dashed line and do not include zero can be considered superior. Difference between treatments is nonsignificant if error bars include both the non-inferiority margin and zero, but result is inconclusive regarding non-inferiority. At 2 months, hypnotherapy was not non-inferior to Pharmacotherapy and findings were in the inconclusive range. At 6 & 12 months, hypnotherapy was found non-inferior to pharmacotherapy.

Appendix Figure 2.. Percent change in UUIEs for Individual Participants

Histogram of % UUIE change on 3-day diary from baseline to 2 months using an exponent transformed (square root) scale. Hypnotherapy results represented in blue and Medications in red. Top bar represents those patients with UUI cure, 100% reduction in UUIE from baseline. Histogram bars below zero represent patients whose UUIE worsened. (One patient in each group had less than −500% improvement, and are not displayed on this graph.)

Appendix Figure 3.. Regression analysis 2,6 & 12 months

Adjusted means results for months 2, 6 & 12, stratified by hypnotic susceptibility. Least squares means calculated by negative binomial regression adjusting for baseline UUI episodes and hypnotic susceptibility. Vertical lines represent 95% CIs. Each least squares mean is calculated using an overall average baseline value of 8.8 UUI episodes on three-day voiding diary. Asterisk (*) indicates significant group difference (p

Figure 1.. Consort Diagram.

Participant Flow through the Study