Retrospective, diagnostic, transversal and single center study to compare voiding dysfunction after SUI surgery with a SIS (Altis®) in women with detrusor underactivity (cases) and those with normal detrusor (controls) according to UDS pre-surgery. Inclusion criteria: women ≥18 years with SUI or Mixed UI (stress predominant) who were operated between June 2013 and December 2020 with a SIS (Altis®) at Urology Department (median follow-up 39 months). Exclusion criteria: women without UDS prior to surgery or without voiding phase in the P/Q, previous anti-incontinence surgery, POP stage ≥2, neurogenic conditions, other concomitant pelvic floor surgery.
Preoperatively, all patients underwent a standardized urogynaecological work-up including: urogynaecological history, pelvic examination, cough stress test (stress test with a bladder volume at least 300 mL measured by ultrasonography), the Spanish validated version of the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) and conventional urodynamic study (according to ICS good urodynamic practice) using a MMS Solar system with water-charged transducers. Urinary symptoms were evaluated during the UDS using a structured questionnaire evaluating the presence of storage (urinary incontinence, daytime frequency, urgency and nocturia) and voiding symptoms (hesitancy, slow- stream, intermittency, straining to void and feeling of incomplete emptying).
Patients were divided into two groups according to detrusor contractility, which was assessed using the projected isovolumetric pressure (PIP) index [PdetQmax + maximum flow rate (Qmax)] with values of 30–75 cmH2O indicating normal contractility [2].
Altis® procedure was performed as standard description by 3 expert surgeons mostly by outpatient setting. Follow-up was carried out with physical examination, ICIQ- SF, TBS (treatment benefit scale), satisfaction visual scale (score 0–10), and cough stress test. Patients were evaluated postoperatively at 1, 6, 12 and 24 months. Voiding symptoms after surgery were actively recorded, as well as incidence of acute urinary retention, need of clean intermittent catheterization and need of des-obstructive surgery. Other adverse events, such as tape exposure and pain related to the procedure or the device, were evaluated at each visit.
To explore the statistical power of our sample, we calculated the necessary sample size based on a previous similar study [1]. We performed a confirmatory sample size calculation. To achieve a power of 85% to detect differences in the contrast of the null hypothesis H₀: p1 = p2 by means of a one-sided Chi-square test for two independent samples, taking into account that the significance level is 5%, and assuming that the proportion of de novo voiding dysfunction in the reference group is 2%, the proportion in the experimental group is 18%, and that the proportion of experimental units in the reference group with respect to the total is 80% [1], it was necessary to include 104 experimental units in the reference group and 26 units in the experimental group, totaling 130 experimental units in the study.