Hypothesis / aims of study
Female Stress Urinary Incontinence (SUI) is funneling more and more women while they are ageing and passing the way from first childbearing event to postmenopause. Majority of them stays confined to the mild degree causing occasional mishaps, but some cases tend to progress affecting substantially quality of life otherwise healthy and active women, when only one riddance remains – surgical intervention. Despite vast array of these procedures, the rate of recurrences leaves a lot to improve. Cystocele with bulging anterior vaginal wall makes affected women contemplate pelvic reconstructive surgery (PRS) even in the case of no other complaints except wall’s laxity and gaping vaginal slit to improve self-esteem, but postoperatively straightened urethra can emerge as the reason of SUI. Therefore pelvic floor muscle (PFM) tone still matters to prevent it from sagging and anatomical disposition after surgical procedures.
Majority of women appear to show low compliance with routine PFM exercises. A breakthrough treatment (EMSELLA) utilizes electromagnetic energy to trigger supramaximal PFM contraction in a single session. Our study aimed to evaluate course EMSELLA procedures within the first half a year after PRS to consolidate postoperative support and prevent from SUI.
Study design, materials and methods
A cross-sectional study involved 56 female patients aged 38-63 years who had been accrued within 2-6 months passed after PRS. The first arm (29 pts) was briefed with conventional postoperative. The second arm (27 pts) underwent 6 sessions of EMSELLA procedure (28 minutes twice per week) annually within 3 years after PRS. Assessment was conducted at the time of accrual and in 3 years after surgery by means of Colpex feedback system (kegel ball with laser pointer and measuring tape on the wall): distance between a point with relaxed PFM and the point at the highest exertion of PFM.
Calculating results of Colpex measurements we encountered the challenging and still vague choice of landmarks for measurements necessary to evaluate this feature. In order to reduce the probability of mistake the new approach for calculation was elaborated on the base of measurement uncertainty.
Measurement uncertainty is a characteristic of inaccuracy of measurements, adopted at the international level [GUM], which is associated with the measurement result and characterizes the range of values that can reasonably be attributed to the measured value. All components of the uncertainty of the input values are divided into two categories in accordance with the method of their estimation: type A includes components evaluated by applying statistical methods (by analyzing the results of multiple measurements) and type B includes components estimated by another method (based on characteristics taken from specification for measuring instrument, calibration certificate, measurement procedure from previous experiments, etc.). Measurement uncertainty is estimated in accordance with the basic algorithm described in [1].
All contributions of the uncertainties of the input quantities form the standard uncertainty of the measured quantity u(Hн) (the total standard uncertainty uc, calculated according to the dispersion summation rule [1].
The coverage factor depends on the distribution law of the measured value and the chosen level of confidence p. For these samples, the hypothesis about the normal distribution law is confirmed, therefore the coverage factor for the probability of 0.95 is assumed to be 2.
Interpretation of results
Electromagnetic approach for women after PRS was associated with reinforced tone of PFM considering elevation of Colpex system by tightened PFM even despite scarry postoperative tissue. In the case of routine postoperative management the gap between swings of measurement was noticed to taper that might have evidenced the weakened PFM support providing no resistance to sagging of pelvic floor (fig. 1).