[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.

[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.

[Transurethral injection of polyacrylamide hydrogel (Bulkamid) for the treatment of female stress urinary inkontinence and changes in the cure rate over time]. / Zmeny lécebného efektu transuretrální aplikace polyakrylamid hydrogelu (Bulkamidu) pri lécbe zenské stresové inkontinence moci 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 and mixed urinary incontinence. The hypothesis was that the cure rate of Bulkamid may slowly decreases over time. DESIGN: Retrospective clinical study. SETTINGS: Gynecological and Obstetric Clinic, 1 LF UK and VFN, Prague. MATERIALS AND METHODS: A retrospective study was performed on 25 women with urinary incontinence (stress 18; mixed 7), and 24 patients completed the study. Nineteen patients had previously undergone anti-incontinence surgery. The efficacy of TUI was evaluated 3 months (+/- 1 week) and an average of 13.5 months (range 6-30 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 and three and - on average - 13.5 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. Ethical committee approval was obtained, and all subjects gave written informed consent to participate in the study. RESULTS: Mean age of patients was 69.7 (SD 16.22) years, mean body mass index (BMI) 27.56 (SD 3.42), and mean parity was 1.73 (SD 0.7). Objective assessment by cough test showed that 9/25 (36%) of patients had negative results for this test 3 months and 4/24 (16.7%) 13.5 months after the operation. Subjective assessment by the ICIQ-UI SF questionnaire showed that 7/25 (28%) of our patients were completely dry 3 months after the operation and 3/24 (12,5%) 13 months after the operation. 20/25 (80%) of patients were dry or improved 3 months after the operation and 14/24 (58.3%) 13.5 months after the operation. The mean score before the operation was 17.56 (SD 3.44), median 18; 3 months after the operation it was 5.68 (SD 5.51), median 5; and 13.5 months after the operation it was 8.25 (SD 5.49), median 7.5. The evaluation of the answers to the question "Overall, how much does leaking urine interfere with your everyday life?" showed a worsening of the situation to a statistical significant degree: 3 months after the operation the mean score was 2.38 (SD 2.28), while 13.5 months after the operation it was 3.79 (SD 2.96). CONCLUSIONS: The hypothesis that the cure rate of Bulkamid may slowly decreases as time passes after the operation was confirmed.

[Correlation between stress urinary incontinence or urgency and anterior compartment defect before and after surgical treatment]. / Vztah stresové inkontinence moci ci urgence k defektu predního kompartmentu pred jeho operacním resením a po nem.

OBJECTIVE: We aimed to assess the occurrence of stress urinary incontinence (SUI) and urgency (U) before and after an operation to treat anterior compartment defect, and to ascertain whether there is a correlation between the position or mobility of the urethro-vesical junction (UVJ) and the lowest point of bladder base (N) and SUI and U before and after surgical treatment of the defect, using various procedures. DESIGN: Prospective, randomized study. SETTINGS: Department of Gynecology and Obstetrics, First Medical Faculty, Charles University and General Teaching Hospital, Prague. MATERIALS AND METHODS: 87 women were enrolled who had proven symptomatic Pelvic Organ Prolapse POP > or = II (Pelvic Organ Prolapse Quantitative--POP-Q)--specifically anterior compartment defect cystocele; they were then randomized into three group according to the type of surgical procedure planned: the BM group, treated with the traditional Barnett-Macku technique of anterior vaginal plastic surgery (BM; n=18); the Gynemesh group, treated with anterior plastic surgery with free insertion of individualized mesh (Mesh; n=33); and the Prolift group, treated with an original kit with pre-set standard-size mesh which is anchored to the lower arm of pubis (Prolift; n=36). SUI tests were carried out for the women before the operation and 3-4 months afterwards, using International Consultation on Incontinence Questionnaire - Short form (ICIQ-UI SF) and objective assessment by cough-test, while we also took into account the urge symptom. Before and after the operation patients were also examined by 4D imaging (GE Voluson 730 Expert), with emphasis on the position of UVJ and N point at rest and at maximum Valsalva. Data were processed and analysed in open computer environment, R language, version 2.9.1. RESULTS: The different groups of patients did not show statistically significant differences in demographic data. The results also show that there is no statistical difference between individual operation groups regarding occurrence of SUI: objectively this was established for 33% of patients, and according to ICIQ for 79%. Among women where SUI was not objectively proven, 74% felt SUI, while among women with objectively proved SUI, only one did not feel the urine leakage. This means that SUI is much more often subjectively felt than objectively proven. After the operation objective improvement of SUI occurred for 6% (5) patients, while it worsened for 16% (12) patients. The differences are not statistically significant. 78% (65 patients; n=83) felt incontinent before the operation compared with 66% (54 patients; n=82) after the operation, according to the ICIQ questionnaire. 18% (14) patients showed improvement and 5% (4) deterioration. In subjective assessment of the symptoms, improvement of SUI is more often recorded than worsening, to a statistically significant degree. 34% (30) patients in total suffered from urge before the operation (for three of them urge incontinence, for the others just urgency) and 8% (7) patients after the operation (of which one suffered from urge incontinence and 6 just urgency). This means that improvement occurred for 32% (25) and deterioration for just 3% (2) if patients. We have not ascertained any correlation between UVJ mobility, N point and urinary incontinence before and after the operation. CONCLUSIONS: The results of our study imply that the presence of SUI and U before an operation to treat anterior compartment defect is one of the main symptoms accompanying prolapse. While the operation may solve the SUI problem, it very often does not, as it deals mainly with eliminating the prolapse, or para-vaginal effect. We also failed to establish any correlation between mobility of the UVJ or N point and occurrence of SUI before and after the operation. We may, however, state that elevation of the N point--bladder base due to the operation results in mitigating U. Therefore, for reconstructive surgeries that do not treat SUI it is necessary that the operation is followed by a tape procedure in the second stage, ideally after the first operation has healed, i.e., 3 months at minimum.

[Changes in the length of implanted mesh after reconstructive surgery of the anterior vaginal wall]. / Zmeny délky implantované sít'ky po rekonstrukcním výkonu prední steny posevní.

OBJECTIVE: To evaluate and quantify early and late changes in mesh length after anterior vaginal repair with implants with ultrasound. TYPE OF STUDY: Prospective interventional study. METHODS: Ultrasound assessment of 35 patient randomized in two groups both with Gynemesh insertion. In one group with Gynemesh Prolift anterior kit and second group with individualized size of the Gynemesh. Ultrasound measurement of the mesh in sagittal plane was performed postoperative day 4 and after 3-4 month. Measured values were put in proportions, together with the original size of the mesh. Results are expressed as a percentage of shortening. RESULTS: In comparison of measurements from the late ultrasound scans with original size the shortening of the Prolift was 45% vs. 25% in Mesh group. When we compared the late and early ultrasound scans, there was no difference in the shrinking of the mesh in both group 16% vs 20%. CONCLUSION: Insufficient spreading and anchoring of the anterior Prolift has a major impact on the final length of the mesh. The tissue reaction expressed as shrinking of the mesh is only 16-20%.

[The solution of persistent stress urinary incontinence in women when surgery with the TVT-SECUR* is unsuccessful]. / Resení pretrvávající stresové inkontinence moci u zen po neúspesné operaci TVT-SECUR*.

OBJECTIVE: The objective of this study is to evaluate the efficacy of the procedure of shortening the tape in the treatment of persistent stress urinary incontinence when the tension-free vaginal tape (TVT) SECUR procedure proves unsuccessful. DESIGN: Retrospective study. SETTINGS: Department of Gynecology and Obstetrics, First Faculty of Medicine, Charles University and General Teaching Hospital, Prague. MATERIALS AND METHODS: Eight patients with persistent stress urinary incontinence (SUI) after the TVT-S procedure were included in our study. In order to resolve their condition, the tape was shortened. We used the overlap and the cut-off technique. Pre- and postoperative urodynamic and ultrasound (US) examinations were carried out, and the efficacy of this procedure was evaluated by cough test, pad-weighting test (PWT) and by the questionnaires Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ12) and the International Consultation on Incontinence Questionnaire--Short form (ICIQ-UI SF). All data were processed and statistical analyses performed in statistical environment R, version 2.5.1. RESULTS: In six patients the cough test and PWT were negative after reoperation, indicating no stress urinary incontinence, while in two patients mild leakage of urine persisted. The reoperation significantly increased the value of Maximum Urethral Closure Pressure (MUCP) while coughing. From the US examination we can conclude that the tape is tightened closer to the urethra and pubic bone. CONCLUSIONS: We describe a method--shortening the tape--for the treatment of persistent stress urinary incontinence when the TVT-S procedure fails. Based on our results we have established that this procedure is simple and as effective as inserting a new tape, but cheaper.

[Long-term review on posterior colporrhaphy with levator ani muscles plication and incorporating a Vypro II mesh]. / Dlouhodobé lécebné výsledky vysoké zadní plastiky s plikací levátoru s pouzitím sít'ky Vypro II.

OBJECTIVE: Pelvic organ prolapse affect 50% of parous women over 50 years of age. The lifetime risk of undergoing a single operation for prolapse or incontinence by age 80 is 11.1%. Recurrence rates for classical prolapse surgery are as high as 30%. For this reason various graft materials have been proposed to improve the long-term surgical outcomes. The aim of our study was to investigate the safety and efficacy of posterior colporrhaphy incorporating Vypro II (polyglactin 910-polypropylene) mesh in the treatment of posterior vaginal wall prolapse. DESIGN: Retrospective study. SETTING: Gynaecological and Obstetric Clinic, First Medical Faculty of Charles University and General University Hospital, Prague. METHODS: Standard posterior colporrhaphy was performed with levator ani muscles plication. Vypro II (Ethicon, Somerville, NJ, USA) is a type III macroporous mixed fibre lightweight mesh composed of 50% absorbable multifilamentous polyglactin 910 and of 50% non-absorbable multifilamentous polypropylene fibres. This operation was performed in 28 women between March 2003 and November 2005. All patients underwent before surgery, urodynamics, ultrasound and physical examination. 22 women (78.5%) had a previous hysterectomy, 16 women (57%) had previous pelvic surgery for prolapse and/or urinary incontinence. Concomitant surgeries performed included vaginal hysterectomy 7% (n = 2), anterior colporrhaphy 50% (n = 14), anterior colporrhaphy with Vypro II mesh 21.4% (n = 6), TVT 7% (n = 2), TVT O 7% (n = 2), sacrospinous vaginal vault suspension 32% (n = 9). The pelvic organ prolapse was staged in ICS POP-Q system. All women had stage II-IV symptomatic prolapse of the posterior compartment (11 patients 39.2% with stage II, 14 patients 50% with stage III and 3 patients 10.7% with stage IV). All patients were examined always in case of complications and were invited to follow-up 2 months after surgery and once a year. The mean follow-up was 26.2 months (range 2-58), whereas 71% of patients had a follow up longer then 24 months. RESULTS: Patients mean age was 63.7 years (range 46-83), mean parity 2.1 (1-3) and mean BMI 30.34 kg/m2 (25-42). There were no operative or early postoperative complications like bowel erosion or rectovaginal fistula. The incidence of rectocele recurrence was 10.7%: 1 case of stage II rectocele and 2 cases of stage III rectocele. The incidence of mesh vaginal erosion was 10.7%. Two cases were resolved by repeated excision in office and by local estrogen and local antimicrobial therapy. The third case required reoperation and mesh exstirpation. CONCLUSION: Posterior colporrhaphy with levator ani muscles plication and incorporating a Vypro II mesh was associated with a higher incidence of post-operative complications even if cure rate was quite good.

[Intrapartal fetal monitoring, sensitivity and specificity of methods]. / Intrapartální fetální monitoring, senzitivita a specificita metod.

OBJECTIVE: To evaluated sensitivity and specificity of presently used methods for intrapartal monitoring (CTG, FpO2 a STAN S-21) and their mutual comparison. TYPE OF STUDY: A prospective study. SETTING: Gynecological-Obstetrical Clinic, 1st Medical Faculty, Charles University and general Teaching Hospital, Prague. METHOD: In 114 pregnant women with high-risk or pathological course of pregnancy the authors evaluated the capability of individual methods to predict intrapartal hypoxia, determined on the basis of postnatal evaluation of parameters observed (Apgar score in 1st minute, pH from umbilical artery, lactate levels in fetal blood, base excess (BE) and postpartum condition of fetus evaluated by a neonatologist). Each method was categorized according to its importance. The quality of individual methods was evaluated by means of their sensitivity and specificity as well as by the area under ROC (Receiver Operating Characteristic), i.e. AUC (Area under Curve). A similar or different prediction of the condition of the newborn by these individual methods was evaluated by the McNamara test of symmetry. In 50 deliveries performed by Cesarean section and 24 forceps deliveries the authors evaluated postnatal pH from umbilical artery and evaluation by Chi-square test. The women in childbed were infused with a tocolytic drug (hexoprenalin) before Cesarean section. All tests were performed at 5% level of significance. RESULTS: Low level of Apgar score in the 1st minute and less) always indicated CTG, but also a large proportion of normal newborns. STAN, in contrast, well indicates all newborns with a normal point evaluation. The best balanced evaluation of the newborns is provided by FpO2 and there was a significant difference between CTG and FpO2. In evaluating pH from the umbilical artery (pH < 7.20), TCG proved to be most sensitive again but displayed low specificity. STAN was the best predictor of newborns with normal pH. In evaluating high levels of lactate (> 3.7mmol/L) and BE (> -10) and related demonstration of metabolic acidosis STAN proved to be the best predictor. The condition of the newborn evaluated by a neonatologist immediately after birth (medium or heavy depression) was best predicted by FpO2. In deliveries performed by Cesarean section and after the administration of tocolysis the postnatal pH was higher then in forceps deliveries without acute tocolysis. The occurrence of emergencies in the course of a pathological delivery in individual methods is as follows: CTG, FpO2 and STAN. CONCLUSION: Even though CTG displays a very low specificity, this method should not be rejected, since it draws attention of the obstetrician very early to the possibility of developing hypoxia. FpO2 or STAN gives more precision to the situation and demarcates a correct moment for ending the delivery for the indication of fetus hypoxia intra partum. STAN is the best predictor for conditions of developing metabolic acidosis, evaluated postnatally by the level of lactate and BE in fetal blood.

[Internal jugular vein thrombosis in a patient with ovarian hyperstimulation syndrome]. / Trombóza vnitrní jugulární zíly u pacientky s ovariálním hyperstimulacním syndromem.

OBJECTIVE: To describe a case of right internal jugular vein thrombosis complicating ovarian hyperstimulation syndrome (OHSS). DESIGN: Case report. SETTING: 1st Medical Faculty, Charles University and General Faculty Hospital, Prague. PATIENT: A 27-year-old primiparous woman undergoing in vitro fertilisation (IVF).