Association between sonographic sling location and success of surgery for stress urinary incontinence.

OBJECTIVE: To determine the relationship between the clinical outcome of suburethral sling surgery for stress urinary incontinence and sling location on ultrasound examination. METHODS: This was a retrospective study of patients diagnosed with stress urinary incontinence who were treated with a suburethral sling by a single surgeon between January 2009 and October 2016. Four-dimensional volumes acquired on transperineal ultrasound at least 3 months postoperatively were analyzed and the gap between the sling and symphysis pubis (sling-pubis gap (SPG)) on Valsalva maneuver was measured. Continence was assessed on a cough stress test at follow-up. RESULTS: A total of 378 patients were included, with a mean follow-up of 14.3 months. The success rate of sling surgery was 89.4%. The mean ± SD SPG on Valsalva maneuver was 12.0 ± 2.5 mm in women who were clinically continent at follow-up and 14.1 ± 2.8 mm in those with failed surgery (P < 0.001). CONCLUSION: A shorter SPG on transperineal ultrasound imaging after suburethral sling surgery is associated with cure of stress urinary incontinence. © 2022 International Society of Ultrasound in Obstetrics and Gynecology.

Pilot study comparing tolerance of transperineal and endoanal ultrasound examination of anal sphincter.

OBJECTIVE: To compare diagnostic possibilities of endoanal (EAUS) and transperineal (TPUS) ultrasound during anal sphincter examination and patients preferences. DESIGN: Prospective study. SETTING: Department of Obstetrics and Gynaecology, 1st Faculty of Medicine, Charles University and General University Hospital, Prague. METHODS: Patients involved had EAUS and TPUS of anal sphincter. First group were patients scheduled for control check after vaginal delivery complicated with anal sphincter injury (post OASI) and adequate suture. Second (control) group contained new patients coming for urogynecological examination with some symptoms of anal incontinence. Refusal were noted and after completing both ultrasounds patients marked on visual analog scale (VAS) the level of dyscomfort and answered few simple questions about their preference of exam in future. RESULTS: This study contains twenty-nine patients (fifteen post OASI and fourteen in control group). Two patients (post OASI) refused EAUS and one patient from control group did not mark the level of dyscomfort. In post OASI group eleven patients (84.6%) considered EAUS as botherless or slighly bothering (VAS 3). The average dyscomfort for EAUS was 1.92 and for TPUS 1.08. Five patients marked EAUS more dyscomfortable as TPUS and this difference is significant (p < 0.05). In control group eleven patients (84.6%) marked EAUS as botherless or slightly bothering (VAS 3). There was no difference between post OASI and control group. We have not found by any exam residual anal sphincter defect in any patient post OASI. For this reason we could not decide about efectivity. In matter of future preference patients would prefer TPUS to EAUS in case of similar effectivity. However, in case of different effectivity patients would prefer the more effective. CONCLUSION: Our patients prefer less dyscomfortable TPUS. The pilot study did not display higher effectivity of EAUS in diagnostics of residual anal sphincter defect.

How accurate are we in urethral mobility assessment? Comparison of subjective and objective assessment.

OBJECTIVE: The knowledge of the mobility of urethra plays important role in patients with stress urinary incontinence and its assessment is a part of standard urogynecological examination. It has been assumed that increased mobility is associated with higher likelihood of successful treatment. There is arbitrary defined cut-off for hypermobile urethra - descend of more than 15 mm or 30-degree resp. 50-degree rotation or more during Valsalva manoeuvre. Clinically we routinely categorize mobility of the urethra as high mobile or hypermobile urethras, low mobile urethra and the situation in-between as mobile urethras. But how accurate are we with such a subjective assessment? We have provided retrospective analysis of mobility of the urethra assessed during the clinical examination by transperineal ultrasound (US) with subjective scoring of the mobility (low, norm, hyper) and compared this assessment with detailed measurement of descent and rotation of the urethra. DESIGN: Retrospective cohort study. SETTING: Ob/Gyn department First Faculty of Medicine, Charles University and General University Hospital, Prague. METHODS: This is a retrospective analysis of urethral mobility of women diagnosed with urodynamic stress incontinence (USI) and treated with tension free vaginal slings during the period 01/2009 - 10/2016. For each patient, there was available description of mobility at the time of preoperative assessment (low-, norm- or hyper-mobile) and we compared this assessment with measured parameters of bladder neck mobility analysed later from stored 4D US volumes. We have measured dorsocaudal movement of the bladder neck (BN) (H-distance). This is the distance of the BN from the horizontal line at the level of lower margin of the symphysis and we compared the position at rest and at Valsalva. Secondly, we measured rotation of the urethra using the gama angle - angle between the line connecting BN to lower margin of symphysis and axis of symphysis at rest and during the Valsalva manoeuvre. Mobility of the BN is the difference between the rest and Valsalva position. We compared the objective parameters of mobility with subjective assessment. We have provided correlation of both objective parameters. RESULTS: 427 patients were treated during the analysed period, 393 had available stored 4D US volume for analysis. Mean age 56.5 years (min 29, max 87, SD 7.9), mean BMI 27.4 (min 18.3, max 39.6, SD 7.9), mean parity 2.14. Mean descent of the bladder neck was 11.8 mm (min -1, max 37; SD 6.9) Mean rotation of the bladder neck was 38.8 degree (min -5, max 118, SD 20.0). When we subjectively assessed the mobility as low the mean mobility was 23.9 ° resp. 7.3 mm, for normal 34.8 ° resp. 10.4 mm and 48.6 ° resp. 15 mm for hypermobile uretras. We have found good correlation of both parameters - H-distance, gama angle - r = 0.693. CONCLUSION: Subjective assessment of mobility of the urethra seems to be reasonably accurate for distinguishing between low and hypermobile uretra.

How durable is the effect of mirabegron in successfully-treated overactive bladder patients? Analysis of a multicentre study.

OBJECTIVE: Many clinical studies indicate that pharmacologic treatment of overactive bladder (OAB) is considered effective and safe, but in real clinical practice a substantial proportion of patients discontinues the treatment. The reason for discontinuing the treatment most frequently reported is lack of efficacy and/or side effects. A further significant proportion of patients reports that they stopped the treatment because the symptoms disappeared or were resolved. This β3 agonist seems to be crucial in providing comparable efficacy in the OAB treatment and better tolerance in comparison with anticholinergics. Our aim was to investigate the durability of the mirabegron effect in successfully treated OAB patients and to understand more fully what prompts patients to return to the medication. Is this merely a subjective decision, or is it based on objective worsening of the symptoms? DESIGN: Analysis of multicentre prospective study. SETTINGS: Gynaecology and Obstetric Department First Faculty of Medicine, Charles University and General University Hospital, Prague. METHODS: This is an analysis of longitudinal multicentre study of OAB mirabegron treatment persistence. After continuing mirabegron treatment for more than 18 months patients were assessed by bladder diary and specific questionnaires. Patients with a UB-VAS score (Urgency Bother Visual Analogue Scale) of 50 or less were asked to stop the mirabegron treatment and restart the treatment any time later if they felt the need. Patients recorded the date of return to medication; they kept a daily bladder diary and filled in the same questionnaires as at the time of medication discontinuation. We provide a comparison of symptoms at the time of mirabegron discontinuation and at the time of mirabegron medication restart. RESULTS: 206 patients entered the study. 176 females (85%) and 30 males (15%) with mean age 62.9 ± 12.43, BMI ranging from 16.6 to 48.0 (mean 27.2 ± 4.96). After 18 months 126 patients were persisting with mirabegron treatment. 89 patients had UB-VAS score 50 (89 of 126 patients, i.e. 71%). Those patients were asked to stop the treatment. From the eligible group of 89 patients, 19 patients (21%) were unwilling to stop the treatment and were therefore excluded. There were no significant differences in bladder diary and QoL characteristics between patients who were unwilling to discontinue the treatment and patients who did stop taking the medication. The group who stopping treatment comprised 70 patients. At the time of last follow-up 22 patients (31%) had not restarted the medication, with mean follow-up of 122.6 days. Therapy was restarted by 48 patients (i.e. 69% of 70). The mean time without treatment was 48 days (± 32.0 days), median 53 days. There was significant worsening of OAB symptoms and subjective bother at the time of restarting the medication. CONCLUSION: Subjective bother based on increase number of frequency, urgency, and nycturia causes patients with positive experience to return to mirabegron treatment. Most patients with successfully-treated symptoms of OAB who discontinue treatment can only do so temporarily. A worsening of the symptoms occurs rather rapidly, because 69% of patients with OAB symptoms successfully treated with mirabegron (UB-VAS 50) are unable to discontinue taking the medication for more than two months.

Classification of descent and mobility of urethrovesic junction in women with stress urinary incontinence - an ultrasound study.

OBJECTIVE: Detect urethrovesical junction descent and mobility values in women with stress incontinence prior to surgical treatment. DESIGN: Retrospective study. SETTINGS: Department of Gynecology and Obstetrics, First Medical Faculty, Charles University, General Teaching Hospital, Prague. METHODS: A retrospective study included 568 patients from three different prospective studies. We have ultrasound data in 560 of them. All of these patients underwent surgical treatment of stress incontinence. During the preoperative examination, patients were subjected to clinical, urodynamic and ultrasound examinations, in which we focused on the urethrovesical junction descent and mobility rate in the maximal Valsavs maneuver. Statistical evaluation of the data was performed by a pair t-test or Wilcoxon test. RESULTS: The mean dorsocaudal descent of the urethrovesical junction was 20.6 mm (SD 8.2, first quantile 14.9, third quantile 25.6 mm). We did not find any statistically significant differences in the acquired parameters at different time periods. CONCLUSION: Due to the high variability of urethrovesical junction descent and mobility, ultrasound examination should be part of all urogynecological preoperative examinations to provide the operator with information on urethrovesical junction descent and mobility prior to surgery and then compare it with postoperative results.

[Degree of satisfaction of patients continuing overactive bladder treatment with mirabegron]. / Stupen spokojenosti pacientu pokracujících v lécbe hyperaktivního mocového mechýre mirabegronem.

OBJECTIVE: Overactive bladder syndrome is chronic disease with high prevalence rate (9-42%). This syndrome requires long term therapy, but the treatment persistence is after 3 months over all 26% with further decline in one-year period as low as 18.5%. Main reasons for stopping the treatment are low efficacy, the medication didnt work as expected and side effects. How much satisfied are patients with mirabegron persisting on its treatment? To answer this question, we provided secondary analysis of multicentre follow-up study of patients on mirabegron. We compared subjective and objective parameters between patients continuing mirabegron treatment and those who discontinued the medication. DESIGN: Secondary analysis multicentre prospective follow-up. SETTINGS: Ob/Gyn department First Faculty of Medicine, Charles University and General University Hospital, Prague. METHODS: It is secondary analysis of multicentre prospective study following patients with mirabegron 50 mg treatment. We have analysed objective data from micturition diary and subjective data using visual analogue scales (UB-VAS - urgency bother visual analogue scale, and TS-VAS - treatment satisfaction visual analogue scale) and compared data between the group of patients continuing mirabegron treatment and patients who stopped the medication during the study. RESULTS: We included 206 patients (176 women, 30 men) with diagnosis of overactive bladder. Patients continuing the treatment (group n1) had baseline UB-VAS 70.1 vs. 75.0 (p = n.s.) in patients who stopped the medication during the follow-up period (group n2). Baseline episodes of severe urgency and urge incontinence where n1 - 5.1 vs. n2 - 6.2 (p = n.s.). Six months urgency bother score UB-VAS was n1 - 32.4 vs. n2 - 58.9 (p < 0,001). Treatment satisfaction TS-VAS was n1 - 80.3 vs. n2 - 57.7 (p < 0,001). Number of severe urgencies with or without urge incontinence was after 6 months n1 - 2.1 vs. n2 - 3.3 (p = n.s.), lower in group continuing the treatment. When comparing the data between patients stopping the medication for reason of low efficacy (group s1) with patients stopping for other reasons (group s2) UB-VAS bas: s1 - 68.5 vs. s2 - 43.9 (p = 0.001); TS VAS s1 - 45.1 vs. s2 - 58.4 (p = n.s.) and number of severe urgency with or without incontinence s1 - 5.9 vs. s2 - 3.2 (p = 0.009). CONCLUSION: Our data shows that patients expectation on treatment with mirabegron is not low. Patients accept treatment either without side effects or with decrease of severe urgency with or without urge incontinence around 50%. Regardless the reason the patients continuing the treatment scale treatment satisfaction - TS-VAS over 70 points.

[Management of recurrent stress urinary incontinence after anti-incontinence surgery]. / Management recidivující stresové inkontinence moci po selhání efektu anti-inkontinentních operací.

OBJECTIVE: The review article describes the possibilities of procedures for failed anti-incontinence surgery - sling procedure or "bulking agent"? DESIGN: Review article. SETTING: Department of Obstetrics and Gynecology, General Faculty Hospital and 1st Medical Faculty, Charles University, Prague. MATERIALS AND METHODS: The correct choice of procedure type to treat persistent SUI (Stress Urinary Incontinence) which persists or soon reoccurs after anti-incontinence surgery is often problematic. The procedures that treat SUI decrease excessive mobility of the urethra by partially compressing it. If the excessive mobility of the urethra and BN (bladder neck) persist and MUCP (Maximal Urethral Closure Pressure) is within normal range, then we choose a new sling operation to treat the persistent SUI. What type of sling procedure is preferable in this situatitons: transobturator, retropubic or possibly SISs (Single Incision Slings)? SISs are not adequately fixed to the surrounding structures after implantation and are often not of the correct size - especially regarding length - with poor compliance (elasticity). For mentioned reasons we do not use them in reoperations. In this cases we choose such a sling which is properly fixed to the surrounding structures, is of sufficient length, and of appropriate elasticity. When choosing the right type of procedure we also have to consider previous operations: for example, whether reconstructive surgery of pelvic floor defects using mesh has been carried out, where the mesh has been placed, and whether it might be an obstacle to the newly implanted sling. If there is a low urethral mobility after the unsuccessful incontinence operation and a low MUCP is observed on urodynamic examination, then we prefer either a retropubic sling or the application of a bulking agent. The decision of which method to choose also depends on other circumstances, such as whether the patient has undergone radiation treatment or more than on previous surgery to treat SUI. The results of urodynamic, ultrasound and other examinations are very important. CONCLUSIONS: The choice of the right type of surgery to treat SUI after a previous failed procedure depends on information and findings from complex examination of the patient. Case history, examination results, imaging and the experience of the surgeon in individual procedures are therefore most important.

[Cure effect and persistence of treatment with Mirabegron in patients with symptoms of overactive bladder: a multicentre clinical study]. / Lécebný efekt a perzistence na lécbe mirabegronem u pacientu s príznaky hyperaktivního mocového mechýre v multicentrické klinické studii.

OBJECTIVE: The objective of this study was to monitor and evaluate the persistence and cure effect of Mirabegron in patients with overactive bladder syndrome after 18 months of treatment. DESIGN: Prospective clinical study. SETTINGS: 10 gynecological and urological departments in CZE. MATERIALS AND METHODS: This is an analysis of a prospective, multicenter monitoring study from May to September 2014. The patients were 18 years old and had symptoms of OAB for a minimum of three months. Patient check-ups were performed 18 months after the first visit. The dosage of Mirabegron was 50 mg per day in 162 patients, though for 44 of the patients the treatment was changed. During the final check-ups it was ascertained how many patients had discontinued treatment with Mirabegron, at first as a proportion of the whole group of patients and then in relation to gender, age, previous treatment with anticholinergic drugs and changes in the treatment during the study. To evaluate treatment efficacy we employed the TS-VAS and PPBC. During the check-up it was ascertained how many patients had discontinued treatment with Mirabegron, and reasons for this were established. The statistics were calculated using the softwares STATISTICA 12 (Statsoft, USA) and SPSS 20.0 (IBM, v.20.0). RESULTS: Prospective monitoring was performed on 206 patients. Their mean age was 62.8 years; mean body mass index for the whole group of patients was 27.3. At the check-up 18 months post-initiation of treatment it emerged that 79 (38.3%) patients had discontinued the treatment. The reasons for discontinuation of treatment were insufficient treatment efficacy (35.4% of patients), while 49.4% cited other reasons (hospitalisation, surgery, gravidity) and 15.2% of patients discontinued therapy because of side effects. The evaluation of treatment persistence with Mirabegron in groups with relation to gender, age and previous treatment with anticholinergic drugs did not establish statistically significant differences. However, there was a statistically significant difference between groups in relation to changes of treatment during study. At the evaluation of the efficacy of the treatment during the check-up 18 months after initiation of treatment the mean TS-VAS was 73.4, a decrease of the scale of bothers evaluated by PPBC before treatment from a mean value of 4.6 to a value of 2.7. CONCLUSIONS: In our clinical study 18 months treatment persistence with Mirabegron was 61.7%. The reasons were reduced side effects and good cure effect of the drug.

Combination treatment with mirabegron and solifenacin in patients with overactive bladder: exploratory responder analyses of efficacy and evaluation of patient-reported outcomes from a randomized, double-blind, factorial, dose-ranging, Phase II study (SYMPHONY).

PURPOSE: This large dose-ranging study explored the benefits of different combinations of mirabegron and solifenacin on health-related quality of life (HRQoL), based on patient-reported outcomes (PROs), and patients ('responders') achieving clinically meaningful improvements in efficacy and HRQoL. METHODS: SYMPHONY (NCT01340027) was a Phase II, placebo- and monotherapy-controlled, dose-ranging, 12-week trial. Adult patients with overactive bladder (OAB) for ≥3 months were randomized to 1 of 12 groups: 6 combination (solifenacin 2.5/5/10 mg + mirabegron 25/50 mg), 5 monotherapy (solifenacin 2.5/5/10 mg, or mirabegron 25/50 mg), or placebo. Change from baseline to end of treatment was assessed, versus placebo and solifenacin 5 mg in: PROs (OAB-q [Symptom Bother/total HRQoL] and Patient Perception of Bladder Condition score), and responders achieving minimally important differences (MIDs) in PROs and predetermined clinically meaningful improvements in efficacy (e.g. <8 micturitions/24 h). Changes in PROs and responders were analysed using an ANCOVA model and logistic regression, respectively. RESULTS: The Full Analysis Set included 1278 patients. Combination therapy of solifenacin 5/10 mg + mirabegron 25/50 mg significantly improved PROs versus solifenacin 5 mg and placebo, and significantly more responders achieved MIDs in PROs and efficacy. Micturition frequency normalization was approximately twofold greater with 10 + 25 mg (OR 2.06 [95 % CI 1.11, 3.84; p = 0.023]) and 5 + 50 mg (OR 1.91 [95 % CI 1.14, 3.21; p = 0.015]) versus solifenacin 5 mg. CONCLUSION: Combining mirabegron 25/50 mg and solifenacin 5/10 mg improves objective and subjective efficacy outcomes compared with placebo or solifenacin 5 mg.

[Ultrasound comparison of adjustable single-incision (Ajust) and transobturator tapes to assess post-operative fixation and function and clinical efficacy]. / Ultrazvuková studie porovnání kvality fixace pásky a lécebného efektu pásky zavádené z jedné incize (Ajust) a transobturatorní pásky TVT-O.

OBJECTIVE: The aim of this study was to compare fixation and mobility of adjustable single-incision (Ajust) and standard transobturator midurethral sling (TVT-O) tapes based on postoperative ultrasound monitoring of the position of the tape at rest and at maximal Valsava (tape descent). The hypothesis was that fixation of SIMS Ajust is comparable to that achieved by the standard transobturator midurethral sling. SETTING: Gynecology and Obstetrics Department, GUH and 1st Charles University Prague; Gynecology and Obstetrics Department Masarykova nemocnice Ústí nad Labem. DESIGN: Randomized trial, secondary analysis of ultrasound follow-up. METHODS: Between May 2010 and May 2012 100 women with proven urodynamic stress urinary incontinence were included in this randomized trial.All patients underwent a complete urogynecological investigation before the procedure (clinical examination, urodynamics, ultrasound examination), and they filled in the ICIQ and iQol questionnaires; after surgery, to evaluate their satisfaction with the procedure, VAS and Likert scales were added.Ultrasound examination as part of each post-operative check-up was performed the first day after surgery, two weeks, three months and one year after surgery. Ultrasound measurements were taken in a supine position at rest and during maximal Valsalva. Position of the bladder neck was assessed, and the position of the tape with respect to upper and lower tape margins. RESULTS: At one-year follow up no differences in subjective cure rates and objective cure rates were observed. In all checks after surgery there was no difference between the position of the tape at rest and at maximal Valsalva between the Ajust and TVT-O groups.The length of the upper and lower tape descent was similar. In TVT-O patients the mean length of upper tape margin descent increased from 8.8 mm on the first day after surgery to 10.0 mm three months after surgery; afterwards it remained stable. For Ajust patients there was virtually the same development - from 9.1 to 12 mm - and there was no further increase in the tape descent following the three-month measurement. CONCLUSIONS: The quality of the tape fixation after the Ajust procedure is as good as after standard transobturator midurethral sling. We did not observe any statistically significant differences in tape position and descent, indicating that the function is similar to obturator tape, which in turn suggests the same clinical efficacy. Ultrasound monitoring should be the part of post-operative monitoring whenever novel surgical techniques are introduced.

[Correlation of subjective and objective assessment of vaginal prolapse surgery - secondary analysis of randomized controlled study in patients with pelvic floor injury treated with vaginal mesh or with sacrospinous ligament fixation]. / Korelace subjektivního a objektivního hodnocení operace vaginálního prolapsu- sekundární analýza výsledku randomizované kontrolované studie pacientek s defektem pánevního dna a operovaných vaginální sítkou nebo závesem na sakrospinózní ligamentum.

OBJECTIVE: We had provided secondary analysis of our randomized controlled study comparing vaginal mesh with sacrospinous fixation for vaginal prolapse. We correlated data from subjective and objective assessment. Secondly we had provided correlations results of subjective and objective assessment between patient with anatomical failure and those without. The aim of this analysis was to provide correlation between objective and subjective outcome measures. DESIGN: Subanalysis of randomized controlled study. SETTING: Obstetric Gynecology Department, First Faculty of Medicine of Charles University and General University Hospital in Prague. METHODS: This is secondary analysis of single center randomized controlled study comparing two standard procedures for vaginal prolapse after hysterectomy in patients with levator avulsion injury. We had analyzed pre- and postoperative subjective POPDI score (Pelvic Organ Prolapse Distress Inventory) and correlated this score with most prolapsed portion of vaginal wall. We had compared all vaginal compartments using POPQ (Pelvic Organ Prolapse Quantification): anterior wall with point Ba, apical with point C, and posterior with point Bp. Subsequently we compared subjective POPDI score in group of patients with anatomical failure and those without. RESULTS: We had included in randomized study 70 women. Mean preoperative POPDI score was 65.25 (3.57-200). We didnt found any correlation between subjective score and objective assessment in preoperative data: POPDI vs. Ba (p = 0.75) POPDI vs. C (p = 0.57) a POPDI vs. Bp (p = 0.22) and no correlation in postoperative assessment. Postoperative POPDI score decreased to 26.1, but there was no difference in POPDI score in woman with anatomical failure and no failure - 17.4 vs. 23.3 (p = 0.64)CONCLUSION: Secondary analysis of randomized controlled study had shown that objective and subjective assessment have poor correlation. We didnt found any correlation between degree of prolapse and intensity of complains. The large inter-individual variability in symptoms and low sensitivity of subjective assessment to detect difference makes subjective assessment as an inappropriate tool as a primary outcome measure of pelvic floor surgery.

[Persistence in the treatment of overactive bladder (OAB) with Mirabegron in a multicentre clinical study]. / Perzistence na lécbe hyperaktivního mocového mechýre (OAB) Mirabegronem v multicentrické klinické studii.

OBJECTIVE: The objective of this monitoring was to evaluate persistence in the treatment of patients with overactive bladder syndrome (OAB) using mirabegron. DESIGN: Prospective clinical study. SETTING: 10 gynecological and urological departments in CZE. MATERIALS AND METHODS: This is an analysis of a prospective, multicenter monitoring which started in May 2014 and will continue for 1 year. This monitoring included patients 18 years old who have had symptoms of OAB for minimum 3 months. The patient check-up was performed 6 months (±2 weeks) after the first visit. The dosage of mirabegron was 50 mg per day. For the evaluation the treatment efficacy we employed the TS-VAS and PPBC. During the check-up it was ascertained how many patients discontinued the treatment with mirabegron, and reasons for this interruption were established. The statistics were calculated using the software SPSS 20.0. RESULTS: A prospective monitoring was performed on 206 patients. Their mean age was 62.8 years (range 23-89); mean body mass index for the whole group of patients was 27.3. At the check-up 6 months post-initiation of treatment it emerged that 55/206 (27%) patiens had discontinued the treatment. The reasons for discontinuation of treatment were: 24/55 (43%) insufficient treatment efficacy, 29/55 (53%) other reasons (the main reasons here were hospitalisation, surgery, gravidity) and 2/55 discontinued therapy because of side effects. The side effects were tachycardia, eye irritation, lower abdominal pain and vasculitis, and they were mild in nature. The termination of the study was 7/28 (25%) in the group of patients without previous treatment before mirabegron. Discontinuation of the treatment in the group of patients with previous anticholinergic treatment was 48/178 (27%). At the evaluation of the efficacy of the treatment during the check-up 6 months after initiation of treatment the mean TS-VAS was 77.5, a decrease of the scale of bothers evaluated by PPBC before treatment from a mean value of 3.56 to a value of 1.77. CONCLUSIONS: Our hypothesis, that persistence in treat-ment with mirabegron would be relatively high due to reduced side effects and better cure effect, was confirmed, and this is the reason for higher rates of persistence in the treatment at 6 months check-up (73%).

[Transurethral injection of polyacrylamide hydrogel (Bulkamid®) for the treatment of recurrent stress urinary incontinence after failed tape surgery]. / Uzití transuretrální aplikace polyacrylamid hydrogelu (Bulkamidu®) k lécbe recidivující stresové incontinence moci po selhání efektu páskových operací

OBJECTIVE: The objective of this study was to evaluate the cure effect of a transurethral injection of Bulkamid® for recurrent female stress and mixed urinary incontinence in women who had undergone failed tape surgery. Our hypothesis was that cure effect of Bulkamid® is positive in patients when previous tape anti-incontinence surgery has been unsuccessful. DESIGN: Retrospective clinical study. SETTINGS: Department of Obstetrics and Gynecology, 1st Medical Faculty, Charles University and General Faculty Hospital in Prague. MATERIALS AND METHODS: This retrospective study featured 34 patients with recurrent urinary incontinence (SUI: 28, mixed: 6 - predominant symptom was SUI) after unsuccessful tape anti-incontinence surgery. 25 of the patients had undergone anti-incontinence surgery more than once. The cure effect of a transurethral injection of Bulkamid® was evaluated an average of 29 months after the surgery; the minimum period after surgery was 6 months. Subjective assessment of the leakage of urine was based on the International Consultation on Incontinence Questionnaire - Short form (ICIQ-UI SF) filled in before and after surgery. An improvement in urinary incontinence was defined as a drop in the score of more than 50%. Objective assessment of leakage of urine was assessed by cough test. The cure effect was evaluated by VAS (Visual Analogue Scale) score and by using the five-point Likert score. Ethical committee approval was obtained, and all subjects gave written informed consent to participate in the study. RESULTS: The mean age of patients was 71.03 years, mean body mass index (BMI) 29.12 and mean parity 1.91. The cough test showed that 4/34 (11.8%) of patients had negative results for this test after the operation. The ICIQ-UI SF questionnaire showed that 14/34 (41.2%) of our patients were dry or improved after surgery. The mean VAS score was 62.4 after the operation. The Likert score was 4 or 5 (cured or improved) after the operation for 88.2% of patients. CONCLUSIONS: Our hypothesis that the cure effect of Bulkamid® operation would be positive in patients who have undergone previous unsuccessful tape anti-incontinence surgery was partially confirmed. The Likert and VAS scores indicate that the effect of Bulkamid® surgery is good; however, an evaluation of the cure effect of this procedure based on the ICIQ-UI SF score is less positive. This kind of operation, which is minimally invasive, is less arduous for patients, and it is also suitable for patients who have refused further surgical treatment.

Comparison of vaginal mesh repair with sacrospinous vaginal colpopexy in the management of vaginal vault prolapse after hysterectomy in patients with levator ani avulsion: a randomized controlled trial.

OBJECTIVE: To compare the efficacy of two standard surgical procedures for post-hysterectomy vaginal vault prolapse in patients with levator ani avulsion. METHODS: This was a single-center, randomized interventional trial, of two standard surgical procedures for post-hysterectomy vaginal vault prolapse: Prolift Total vs unilateral vaginal sacrospinous colpopexy with native tissue vaginal repair (sacrospinous fixation, SSF), during the period from 2008 to 2011. Entry criteria included at least two-compartment prolapse, as well as complete unilateral or bilateral levator ani avulsion injury. The primary outcome was anatomical failure based on clinical and ultrasound assessment. Failure was defined clinically, according to the Pelvic Organ Prolapse Quantification system, as Ba, C or Bp at the hymen or below, and on translabial ultrasound as bladder descent to 10 mm or more below the lower margin of the symphysis pubis on maximum Valsalva maneuver. Secondary outcomes were evaluation of continence, sexual function and prolapse symptoms based on validated questionnaires. RESULTS: During the study period, 142 patients who were post-hysterectomy underwent surgery for prolapse in our unit; 72 of these were diagnosed with an avulsion injury and were offered participation in the study. Seventy patients were randomized into two groups: 36 in the Prolift group and 34 in the SSF group. On clinical examination at 1-year follow-up, we observed one (3%) case of anatomical failure in the Prolift group and 22 (65%) in the SSF group (P < 0.001). Using ultrasound criteria, there was one (2.8%) failure in the Prolift group compared with 21 (61.8%) in the SSF group (P < 0.001). The postoperative POPDI (Pelvic Organ Prolapse Distress Inventory) score for subjective outcome was 15.3 in the Prolift group vs 21.7 in the SSF group (P = 0.16). CONCLUSION: In patients with prolapse after hysterectomy and levator ani avulsion injury, SSF has a higher anatomical failure rate than does the Prolift Total procedure at 1-year follow-up.

[Transurethral injection of polyacrylamide hydrogel (Bulkamid®) for the treatment of female stress urinary incontinence and changes in the cure rate over time]. / Transuretrální aplikace polyacrylamid hydrogelu (Bulkamidu®) pri lécbe zenské stresové inkontinence mocia zmeny lécebného efektu v závislosti na case od operace.

OBJECTIVE: The objective of this study was to evaluate short term and long term efficacy of a transurethral injection (TUI) using bulking agent Bulkamid® for female stress (SUI) and mixed urinary incontinence by women with ISD or where anti-incontinence surgery has failed. DESIGN: Retrospective clinical study. SETTINGS: Gynecological and Obstetric Dpt. 1st Medical Faculty UK and VFN, Prague. MATERIALS AND METHODS: A retrospective study was performed on 52 women with urinary incontinence (stress, 43; mixed 9). One patient died during study. Forty patients had previously undergone anti-incontinence surgery. The efficacy of TUI was evaluated 3 months (± 1 week) and an average of 22 months after surgery. Subjective assessment of the leakage of urine was based on the International Consultation on Incontinence Questionnaire - Short form (ICIQ-UI SF) filled in before, three and - on average - 22 months after the surgery (minimum time after surgery was 6 months). Improvement in urinary incontinence was defined as a drop in the score of more than 50%. Objective assessment of leakage of urine was assessed by cough test. The cure effect was evaluated by VAS (Visual Analogue Scale) score and by using the five-point Likert score. Ethical committee approval was obtained, and all subjects gave written informed consent to participate in the study. RESULTS: Mean age of patients was 70 years, mean body mass index (BMI) 28.65, and mean parity was 1.76. The cough test showed that 19/51 (37.3%) of patients had negative results for this test 3 months and 10/51 (19.6%) 22 months after the operation. The ICIQ-UI SF questionnaire showed that 16/51 (31.4%) of our patients were completely dry 3 months after the operation and 8/51 (15.7 %) 22 months after the operation. 41/51 (80.4%) of patients were dry or improved 3 months after the operation and 23/51 (45.13%) 22 months after the operation. The mean cure effect evaluated by VAS score 3 months after the operation was 72 and 22 months after the operation it was 51.3. The Likert score was 4 or 5 (cured or improved) three and 22 months after operation by 78.4% / 54.9% patients. CONCLUSIONS: The cure effect of Bulkamid® operation decreases in correlation with the time that elapses after the operation, although this procedure is minimally invasive and is an option in cases where anti-incontinence surgery has failed.

[Nocturia, incidence, ethiology, diagnostics]. / Epidemiologie, etiologie a diagnostika nykturie.

Nocturia is the complaint that the individual has to wake at night one or more times to void, according to the International Continence Society definition from the ICS Standardisation of Terminology Report 2002. As the nocturia definition is complicated there are also other slightly modified definitions. It is currently not absolutely clear if prevalence or incidence is more important for epidemiology evaluation of nocturia. Nocturia is a variable symptom and its presence in individuals is reversible therefore it is very difficult to obtain reliable incidence data. Nocturia prevalence varies remarkably in different studies according to evaluation methodology, nocturia definition, methods of data collection and characteristics of evaluated population. There are not enough studies, especially demographic ones, evaluating lower urinary tract symptoms and/or nocturia in males and females. There is relatively large number of comparative studies confirming strong correlation between aging and prevalence of nocturia. Prevalence of two or more voids per night in individuals in their twenties varies between 5-15 %, it progresses with age, and in the seventh decade of life ranges between 35-50 %. Prevalence evaluated by gender is higher among younger women compared to older women and older men compared to younger men. Currently there are only limited sources of data regarding nocturia incidence. Incidence of nocturia (two or more voids per night) in a population older than 60 years is 213 new cases/1000 persons/1 year in two year observation. Incidence of two or more voids per night is 75 new cases/1000 male/1 year in five year observation and 126 new cases/1000 male/1 year in ten year observation in male population. Incidence of nocturia rises significantly with age. Incidence of two or more voids per night increases by 2,7 % in the population of women after child birth during 5 year follow up and by 5,9 % during 12 year follow up. Incidence of nocturia newly diagnosed in a pregnancy drops down by 98% in 3 month after the child birth. The incidence data indicate that incidence of nocturia rises with age and probability of nocturia relief decreases with age. Incidence of mild nocturia is higher compared to incidence of severe nocturia and significant relief of nocturia in women after child birth is very inconsistent compared to increase of other lower urinary tract symptoms. Ethiology of nocturia might be polyuria, nocturnal polyuria or reduced bladder capacity. Nocturia and its ethiology can be determined in most cases with simple and commonly used investigative methods on the out-patients bases. The diagnostic algorithm should lead to verification of nocturia and identifying its cause because treatment of nocturia differs remarkably according to the etiology.

[Doctors specialty training in obstetrics and gynecology at university medical schools: 2012-2013]. / Specializacní vzdelávání v gynekologii a porodnictví na lékarských fakultách: 2012-2013.

OBJECTIVE: The paper addresses transfer of doctors specialty training from the national Institute of postgraduate medical education (IPVZ) to University Medical Schools (UMS) with the special focus to Obstetrics and Gynecology (OG). METHODS: The National Specialty Board (NSB) has been established. NSB tasks include definition of inclusion criteria and process of specialty choice at UMS. In OG specialty there are defined mid-term and final postgraduate training courses and other requirements for final specialty exam (FSE) - in particular trainees scientific work and surgery done with the supervision of NTB member. The system of FSE, its content, application, reimbursement and mechanisms are described in details. RESULTS: In the whole country in 2012 there have been done 864 FSE in all basic medical specialties, which took place at seven UMS. Autumn semester terms has been utilized significantly more than spring terms (57% vs. 43%). There have been differences in the numbers of specialties and also numbers of candidates in each specialty among different UMS. In total 94% of applicants succeed in the FSE. In 2012 within OG specialty training there has been held 56 FSE - 24 exams on five UMS in spring term and 32 (57%) exams only on two UMS in autumn term. In the spring 2013 FSE were organized on 1st LF UK in Prague with 23 applicants, from which 22 successfully passed. During autumn 2013 the FSE in OG will be held on LF UP in Olomouc with 44 applicants for final postgraduate training course and 39 candidates for FSE. CONCLUSION: Within OG specialty the transfer of doctors specialty training from IPVZ to UMS has been successfully managed. The NSB in OG specialty closely cooperates with past IPVZ and the Accreditation Commission of the Czech Ministry of Health. Thus continuity, quality and continuous enhancement of specialty training program in OG in Czech Republic is assured.

[Nocturnal polyuria, treatment with desmopressin]. / Lécba nocní polyurie desmopresinem.

UNLABELLED: Nonpharmacologic and especially pharmacologic treatment options are available for nocturnal polyuria. Desmopressin represents the basis of pharmacologic treatment. Desmopressin acetate is a synthetic analogue of arginine vasopressin with high affinity to V2 receptors with antidiuretic effect. It is the only medicament currently registered for antidiuretic treatment. Desmopressin has not any relevant affinity to V1 receptors, and therefore there is no hypertensive effect in contrary to natural vasopressin. Desmopressin use before a bedtime leads to reduced production of urine during a sleep, therefore time between desires to void is prolonged and number of nocturia is reduced. Clinical effect, in a meaning of reduced urine production and increased osmolality of urine, lasts approximately 8-12 hours. In the treatment of nocturnal polyuria desmopressin is used orally one hour before a bedtime. It is essential to titrate an ideal dose, the initial dose is 60 µg of MELT formula (fast melting oral formulation) and it can be increased according to the clinical effect up to the maximal recommended daily dose 240 µg. Patients treated with desmopressin should cut down a fluid intake 1 hour before and 8 hours after the use of desmopressin. Total number of adverse events connected withdesmopressin treatment in clinical studies was higher compared to placebo but the side effects were mostly mild. The most common adverse events were headaches, nausea, diarrhoea, abdominal pain, dry mouth and hyponatremia both in the short-term and long-term clinical trials. Hyponatremia was observed mainly in patients over 65 year of age. Therefore treatment with desmopressin should not be commended in patients over 65 year of age without close monitoring of the natrium level in serum and all patients should be informed about the first symptoms of hyponatremia - headache, nausea and insomnia. According to Evidence Based Medicine, the level of evidence for treatment of nocturnal polyuria with desmopressin is 1b and the grade of recommendation for treatment is A. KEYWORDS: nocturnal polyuria - treatment - desmopressin.

[Persistence of the treatment of overactive bladderin Czech Republic]. / Perzistence uzívání lécby hyperaktivního mocového mechýre v Ceské republice.

INTRODUCTION: Overactive bladder is chronic disease with high prevalence rate (9-42%). This syndrome requires longterm therapy but the persistence of this treatment in comparison with other chronic diseases as diabetes, hypertension, osteoporosis etc. is low. Accorging many studies the persistence variability is high and could be influenced by regional circumstanses. We desided to analyze real situation in parasympatolytics persitance in two years period in Czech Republic based on registry of health insurance company. METHODS: We analyzed data between 2009 and 2010 of all clients of health insurance company where they fullfil their prescribtion. We analyzed the persistence in one year period in different periods of the year and within one year. RESULTS: In comparison of the same period between those two year there was a trend of increase of prescription but it was not significant: 1306(SD 56.3) vs 1410 (SD 68.1) - p = 0.056. Prescription of the treatment after one year was only 18.5%(min. 16.8 - max. 20.4, SD 1.56). Major drop-out was in first 3-month period where renewed their prescription only 25.9% of the patients. CONCLUSION: This one of the first study analyzing the parasympatolytics prescription persistence based on registry of health insurence company. The persistence in Czech Republic was low but withing the range of international data. Those result should be used as a reference data for comparison of the effect of varius strategies influencing the overactive bladder treatment.

A comparison of the incidence of early postoperative infections between patients using synthetic mesh and those undergoing traditional pelvic reconstructive surgical procedures.

New mesh-related complications such as erosion, etc., can result from abnormal postoperative healing due to surgical site infection. The aim of our study was to compare systemic inflammatory responses and the incidence of early infectious complications after reconstructive surgery using synthetic mesh and after traditional vaginal wall repair. In this prospective observational study 99 women with symptomatic pelvic organ prolapse were included; 55 women underwent traditional repair and 44 repair using mesh. After the procedure infectious complications were monitored. The patients who underwent reconstructive surgery using mesh material were more likely to have febrile morbidity in the postoperative period than the patients who had been treated with traditional repair (p=0.031); there was a higher incidence of combination febrile morbidity with elevated C-reactive protein (CRP) > 50 mg/l; p=0.046, and a higher incidence of CRP increase over 30 mg/l; p=0.005. Reconstructive procedures using synthetic mesh are accompanied by a higher incidence of early post-operative infectious complications.