Preliminary 12-month data for a single-incision sling for surgical management of SUI
Erickson T, Roovers JP, Gheiler E, et al. A multicenter prospective study evaluating efficacy and safety of a single-incision sling procedure for stress urinary incontinence. J Minim Invasive Gynecol. 2021;28:93-99. doi: 10.1016/j.jmig.2020.04.014.
In this industry-sponsored study, researchers compared a novel single-incision sling to currently available midurethral slings for SUI with 12-month outcomes and adverse event details. However, results are primarily descriptive with no statistical testing.
Study details
Patients were eligible for inclusion in this prospective, nonrandomized cohort study if SUI was their primary incontinence symptom, with confirmatory office testing. Exclusion criteria included POP greater than stage 2, prior SUI surgery, plans for future pregnancy, elevated postvoid residuals, or concomitant surgical procedures. The single-incision Altis (Coloplast) sling was compared to all commercially available transobturator and retropubic midurethral slings. The primary outcome of this study was reduction in 24-hour pad weights, and secondary outcomes included negative cough-stress test and subjective patient-reported outcomes via validated questionnaires.
Results
A total of 184 women were enrolled in the Altis group and 171 in the comparator other sling group. Symptom severity was similar between groups, but more patients in the comparator group had mixed urinary incontinence, and more patients in the Altis group had intrinsic sphincter deficiency. The Altis group had a higher proportion of “dry patients,” but otherwise the outcomes were similar between the 2 groups, including negative cough-stress test and patientreported outcomes. Two patients in the Altis group and 7 patients in the comparator group underwent device revisions. Again, statistical analysis was not performed.
Single-incision slings may reduce the risk of groin pain associated with transobturator slings and may be a good option for patients who desire less mesh burden than the traditional retropubic slings or who are not good candidates. This trial suggests that the Altis single-incision sling may be similar in outcomes and adverse events to currently available midurethral slings, but further, more rigorous trials are underway to fully evaluate this—including a US-based multicenter randomized trial of Altis single-incision slings versus retropubic slings (ClinicalTrials.gov Identifier: NCT03520114).
Office-based pessary care can be safely spaced out to 24 weeks without an increase in erosions
Propst K, Mellen C, O’Sullivan DM, et al. Timing of office-based pessary care: a randomized controlled trial. Obstet Gynecol. 2020;135:100-105. doi: 10.1097 /AOG.0000000000003580.
For women already using a pessary without issues, extending office visits to every 6 months does not increase rates of vaginal epithelial abnormalities, according to results of this randomized controlled trial.
Study details
Women already using a Gelhorn, ring, or incontinence dish pessary for POP, SUI, or both were randomized to continue routine care with office evaluation every 12 weeks versus the extended-care cohort (with office evaluation every 24 weeks). Women were excluded if they removed and replaced the pessary themselves or if there was a presence of vaginal epithelial abnormalities, such as erosion or granulation tissue.
Results
The rate of vaginal epithelium erosion was 7.4% in the routine arm and 1.7% in the extended-care arm, meeting criteria for noninferiority of extended care. The majority of patients with office visits every 24 weeks preferred the less frequent examinations, and there was no difference in degree of bother due to vaginal discharge. There was also no difference in the percentage of patients with unscheduled visits. The only factors associated with vaginal epithelium abnormalities were prior abnormalities and lifetime duration of pessary use.
As there are currently no evidenced-based guidelines for pessary care, this study contributes data to support extended office-based care up to 24 weeks, a common practice in the United Kingdom. During the COVID-19 pandemic, with reduced health care access, these findings should be reassuring to clinicians and patients.
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