Background
Women with refractory urgency urinary incontinence can be treated with onabotulinumtoxinA
or sacral neuromodulation. Little data exists on the comparative effects of treatment
of refractory urgency urinary incontinence on other pelvic floor complaints, such
as bowel and sexual function.
Objective
The objective of this study was to compare the impact of these treatments on fecal
incontinence and sexual symptoms.
Methods
This was a planned supplemental analysis of a randomized trial in women with refractory
urgency urinary incontinence treated with onabotulinumtoxinA (n = 190) or sacral neuromodulation
(n = 174). Fecal incontinence and sexual symptoms were assessed at baseline and at
6, 12, and 24 months. Fecal incontinence symptoms were measured using the St Mark’s
(Vaizey) Fecal Incontinence severity scale. Sexual symptoms were measured using the
Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire-12 (PISQ-12) and the
Pelvic Organ Prolapse/Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR). The
PISQ-IR allows measurement of sexual symptoms in both sexually active and non–sexually
active adults. Primary outcomes were change in Vaizey and PISQ-12 scores between baseline
and 6 months. Secondary outcomes were change in PISQ-IR total and subscores between
baseline and 6 months and change in Vaizey, PISQ-12, and PISQ-IR scores between baseline
and 12 and 24 months. Intent-to-treat analysis was performed using repeated measures
mixed model to estimate change in all parameters from baseline while adjusting for
the baseline score. A subgroup analysis of women with clinically significant bowel
symptoms was conducted based on baseline Vaizey score of ≥12.
Results
At baseline, mean Vaizey scores were indicative of mild fecal incontinence symptoms
and were not different between onabotulinumtoxinA and sacral neuromodulation groups
(7.6 ± 5.3 vs 6.6 ± 4.9, P = .07). The proportion of sexually active women (56% vs 63%, P = .25), mean PISQ-12 score (33.4 ± 7.5 vs 32.7 ± 6.7, P = .55), or PISQ-IR subscores were also not different between the onabotulinumtoxinA
and sacral neuromodulation groups at baseline. There was no difference between women
treated with onabotulinumtoxinA and those treated with sacral neuromodulation at 6
months in terms of improvement in fecal incontinence symptom score (Vaizey: -1.9,
95% confidence interval -2.6 to -1.2 vs -0.9, 95% confidence interval -1.7 to -0.2,
P = .07) or sexual symptoms score (PISQ-12: 2.2, 95% confidence interval 0.7 to 3.7
vs 2.2, 95% confidence interval 0.7 to 3.7, P = .99). There was no difference in improvement between groups in the sexual symptom
subscores in sexually active and non–sexually active women at 6 months. Similar findings
were noted at 12 and 24 months. In a subgroup (onabotulinumtoxinA = 33 and sacral
neuromodulation = 22) with clinically significant fecal incontinence at baseline (Vaizey
score ≥12), there was a clinically meaningful improvement in symptoms in both groups
from baseline to 6 months, with no difference in improvement between the onabotulinumtoxinA
and sacral neuromodulation groups (-5.1, 95% confidence interval -7.3 to -2.8 vs -5.6,
95% confidence interval -8.5 to -2.6, P = .8).
Conclusion
There were no differences in improvement of fecal incontinence and sexual symptoms
in women with urgency urinary incontinence treated with onabotulinumtoxinA or sacral
neuromodulation. Women with significant fecal incontinence symptoms at baseline had
clinically important improvement in symptoms, with no difference between the treatments.
Our findings can help clinicians counseling women considering treatment for refractory
urgency urinary incontinence.
Key words
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Article Info
Publication History
Published online: June 15, 2019
Accepted:
June 10,
2019
Received in revised form:
May 17,
2019
Received:
December 31,
2018
Footnotes
Supported by grants from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institutes of Health Office of Research on Women’s Health .
The authors report the following potential conflicts of interest: Uduak U. Andy: PI Grant R03-AG-053277-01, National Institute on Aging, NIH; PI Industry Grant, Pelvalon Inc ; Gena Dunivan and Keisha Y . Dyer: PI Industry Grant, Pelvalon Inc; Sandip Vasavada : Consulting, Medtronic, Allergan, BlueWind, and Amphora. The following authors report no conflicts of interest: Cindy L. Amundsen, Emily Honeycutt, Alayne D. Markland, Nicole B. Korbly, Megan Bradley, Donna Mazloomdoost, and Sonia Thomas.
ClinicalTrials.gov Identifier: NCT01502956.
Cite this article as: Andy UU, Amundsen CL, Honeycutt E, et al. Sacral neuromodulation versus onabotulinumtoxinA for refractory urgency urinary incontinence: impact on fecal incontinence symptoms and sexual function. Am J Obstet Gynecol 2019;221:513.e1-15.
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- November 2019 (vol. 221, no. 5)American Journal of Obstetrics & Gynecology
