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Predictors of Macroplastique Success in the Treatment of Incontinent Women
Max Schmidt-Bowman, BS1, Annah Vollstedt, MD2, Zhonge Li, MS3, Veronica Triaca, MD4.
1Geisel School of Medicine, Hanover, NH, USA, 2Dartmouth Hitchcock Medical Center, Lebanon, NH, USA, 3Biostatistics Shared Resource, Norris Cotton Cancer Center, Dartmouth College, Lebanon, NH, USA, 4Concord Hospital for Urologic Care, Concord, NH, USA.
Urethral bulking procedures are commonly performed, both as a primary treatment to address stress urinary incontinence (SUI) in women and as a salvage treatment following failure of other solutions. Success rates vary among patients and little is known about what patient characteristics are associated with bulking success or failure. The purpose of this study is to determine which factors serve as predictors of urethral bulking success in stress incontinent women.
This IRB approved retrospective chart review included 94 women with urinary incontinence treated with a Macroplastique® (Cogentix Medical Inc.) urethral bulking procedure between August 2013 and November 2016. All patients had completed an Incontinence Symptom Severity Index1, a previously validated self-assessment survey of female urinary storage and voiding symptoms, before and after injection of Macroplastique®. Pre-procedural and post-procedural ISS questionnaire responses were used to evaluate the success of the urethral bulking procedure, particularly ISSQ3 and ISSQ4 as these questions focus upon SUI symptoms.
3. Do you experience leakage related to physical activity, coughing or sneezing? How much does this bother you?
4. Do you experience small amounts of urine leakage (drops)? How much does bother you?
Both questions were scored as 0 (no symptoms), 1 (mildly), 2 (moderately), 3 (greatly). Forty-four women were excluded, 3 because they are since deceased and 41 who had only pre-procedural or post-procedural questionnaire data recorded, leaving a cohort of 50 living women with both pre- and post-injection data. Of these 50, 30 of the women previously had mid-ureteral slings. We used a binomial test with exact method to assess whether there was a significant proportion of improvement in pre- to post-procedure scores. Additionally, we applied multivariate logistic model to analyze whether there were certain patient characteristics (age, BMI, smoking status, use of vaginal estrogen, history of hysterectomy, or the presence of mixed urinary incontinence) that may predict improvement or not with Macroplastqiue®.
Of the cohort of 50 women, pre- and post- procedural ISSQ3 averages were 1.84 and 1.36, respectively. Average scores for ISSQ4 were 1.46 and 1.14, respectively. The overall improvement in ISSQ3 responses was significant (p=0.04), however there was no significant difference in ISSQ4 (p=0.13). Of the patient characteristics analyzed, vaginal estrogen use showed a significantly negative association with improvement of Q4, odds ratio of 0.10 (p=0.02, 95% CI 0.02, 0.69). No other patient characteristics were negatively or positively statistically significant predictors of improvement for either Q3 or Q4.
Our results show that Macroplastique® is overall an effective procedure in our population. However, no particular characteristics were shown to predict improvement other than vaginal estrogen use, which is negatively correlated with improvement in ISSQ4 responses alone. Our results validate the efficacy of the Macroplastique® injection procedure as management for SUI in this cohort and support its use in patients in whom other treatment options may not be possible.
1 Twiss C, Triaca V, Anger J et al. Vaildating the Incontinence symptom severity index: a self-assessment instrument for voiding symptom severity in women. J Urol 2009; 182: 2384
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