Cíl: Cílem práce je srovnat efektivitu dvou miniinvazivních operačních metod ženské stresové inkontinence (Ajust™ a MiniArc™) pomocí subjektivního hodnocení a objektivních parametrů. Metoda: Do prospektivní randomizované multicentrické studie bylo zařazeno celkem 66 pacientek ve věku 57,8 let (42-88) se stresovou inkontinencí. Pacientky ve skupině A byly operovány metodou Ajust™, pacientky zařazené do skupiny B byly operovány metodou MiniArc™. Subjektivní spokojenost s výsledkem operace byla hodnocena pomocí standardizovaného dotazníku The International Consultation on Incontinence (ICI-Q). Objektivní hodnocení výsledků jsme provedli pomocí kašlacího testu, urodynamických (objem při prvním nucení na močení - FDV, cystometrická kapacita - CC, maximální uzávěrový uretrální tlak - MUCP, maximální průtok moči - Q ) a ultrazvukových parametrů (rozdíl úhlu gama-gamadif vzdálenost mezi vezikouretrální junkcí v klidu a při provedení Valsalvova manévru - d). Všechny hodnocené parametry byly měřeny vždy před léčbou a 3 měsíce po operační léčbě. Statistické hodnocení bylo provedeno pomocí dvouvýběrového t-testu a neparametrického dvouvýběrového Wilcoxonova testu s korekcí na shodu pořadí. Výsledky: Při hodnocení subjektivní spokojenosti pacientek s provedenou operací jsme zjistili, že u obou typů operací došlo pooperačně k významnému zlepšení v celkovém skóre (-14,09 ± 5,18 vs. -14,45 ± 3,73), mezi jednotlivými operačními metodami nebyl statisticky významný rozdíl (p = 0,74569). Při hodnocení efektu operace bylo dle kašlacího testu celkem 61 pacientek (92,43%) bez průkazu stresového úniku moči. Ve skupině A to bylo 31 (94 %) pacientek, ve skupině B 30 (91 %) pacientek. Při srovnání hodnocených urodynamických parametrů před operací a po operaci došlo ke statisticky významně většímu nárůstu cystometrické kapacity u pacientek ve skupině B. V dalších urodynamických parametrech nebyly pozorovány statisticky významné rozdíly mezi oběma typy operací. Ve srovnání s předoperačním vyšetřením došlo u obou typu operací k jednoznačnému omezení mobility uretrovezikálního spojení měřené introitální sonografií. Došlo jak ke snížení hodnoty úhlu gama (-13,82 ± 21,63 vs. -9,82 ± 17,17), tak ke zkrácení úsečky d (-3,75 ± 6,93 vs. -3,53 ± 5,53). Nebyly nalezeny statisticky významné rozdíly mezi jednotlivými operačními metodami. Závěr: Naše první zkušenosti s operačními metodami Ajust™ a MiniArc™, které se týkají efektivity a možných per- či pooperačních komplikací, jsou dobré. Z hodnocení těchto operací provedeného 3 měsíce po operaci vyplývá, že efektivita obou operací je obdobná. Pro definitivní hodnocení je nutné další sledování souboru s jeho vyhodnocením v delším časovém odstupu.

Aim: Aim: The aim of the study was to compare the effectiveness of two minimally invasive surgical techniques for stress urinary incontinence in female patients (Ajust™ and MiniArc™), using subjective assessment as well as evaluation of objective parameters. Methods: A total of sixty-six female patients with stress urinary incontinence were enrolled into the prospective, randomized, multicentre trial, mean age 57.8 years (range 42-88 years). Patients in Group A had undergone surgery using Ajust™ method; patients in Group B underwent surgery using the MiniArc™ method. The subjective satisfaction of the patients along with the outcome of the procedure was evaluated using a standardized questionnaire "The International Consultation on Incontinence (ICI-Q)". The objective assessment was performed with the use of cough test, urodynamics (bladder volume at the first desire to void - FDV, cytometric capacity - CC, maximum urethral closure pressure - MUCP, maximum urinary flow - Qmax), and ultrasound parameters (difference between the gamma-gammadif angles, distance between vesicourethral junction at rest and during the Valsalva maneuver - d). All of the parameters were measured prior to treatment, and three months following the surgical procedure. Statistical evaluation was performed with the two-choice t-test and nonparametric two-choice Wilcoxons test, with the correction for sequence alignment. Results: When assessing the subjective satisfaction of the procedure, we found, that both groups of patients reported a significant improvement in the total score (-14.09 ± 5.18 vs. -14.45 ± 3.73), no significant difference was observed between the two methods (p = 0.74569). Objective assessment of the surgical procedure documented a lack of incontinence in a total of 61 patients (92.43%) following surgery. These included 31 patients (94%) from Group A and 30 patients from Group B (91%). When we compared the urodynamic parameters before and after the surgery, we observed a significant increase of the cytometric capacity in patients of Group B. No other statistically significant differences between these two surgical procedures were observed in the other parameters. A clear decrease in the uretrovesical junction mobility was observed in comparison with the pre-surgery measurements using introital sonography. We observed a decrease in the gamma angle (-13.82 ± 21.63 vs. -9.82 ± 17.17), as well as a shortening of the d line segment (-3.75 ± 6.93 vs. -3.53 ± 5.53). No statistically significant differences were observed between both methods of surgical treatment. Conclusion: Our initial experience with the surgical techniques Ajust™ and MiniArc™, with respect to the effectiveness and possible per- or postoperative complications, are good. From our assessment carried out at three-month follow-up after the surgery it is apparent that the effectiveness of both surgical procedures are comparable. However, further follow-up is necessary for a definitive assessment of both methods. The aim of the study was to compare the effectiveness of two minimally invasive surgical techniques for stress urinary incontinence in female patients (Ajust™ and MiniArc™), using subjective assessment as well as evaluation of objective parameters. Methods: A total of sixty-six female patients with stress urinary incontinence were enrolled into the prospective, randomized, multicentre trial, mean age 57.8 years (range 42-88 years). Patients in Group A had undergone surgery using Ajust™ method; patients in Group B underwent surgery using the MiniArc™ method. The subjective satisfaction of the patients along with the outcome of the procedure was evaluated using a standardized questionnaire "The International Consultation on Incontinence (ICI-Q)". The objective assessment was performed with the use of cough test, urodynamics (bladder volume at the first desire to void - FDV, cytometric capacity - CC, maximum urethral closure pressure - MUCP, maximum urinary flow - Qmax), and ultrasound parameters (difference between the gamma-gammadif angles, distance between vesicourethral junction at rest and during the Valsalva maneuver - d). All of the parameters were measured prior to treatment, and three months following the surgical procedure. Statistical evaluation was performed with the two-choice t-test and nonparametric two-choice Wilcoxons test, with the correction for sequence alignment. Results: When assessing the subjective satisfaction of the procedure, we found, that both groups of patients reported a significant improvement in the total score (-14.09 ± 5.18 vs. -14.45 ± 3.73), no significant difference was observed between the two methods (p = 0.74569). Objective assessment of the surgical procedure documented a lack of incontinence in a total of 61 patients (92.43%) following surgery. These included 31 patients (94%) from Group A and 30 patients from Group B (91%). When we compared the urodynamic parameters before and after the surgery, we observed a significant increase of the cytometric capacity in patients of Group B. No other statistically significant differences between these two surgical procedures were observed in the other parameters. A clear decrease in the uretrovesical junction mobility was observed in comparison with the pre-surgery measurements using introital sonography. We observed a decrease in the gamma angle (-13.82 ± 21.63 vs. -9.82 ± 17.17), as well as a shortening of the d line segment (-3.75 ± 6.93 vs. -3.53 ± 5.53). No statistically significant differences were observed between both methods of surgical treatment. Conclusion: Our initial experience with the surgical techniques Ajust™ and MiniArc™, with respect to the effectiveness and possible per- or postoperative complications, are good. From our assessment carried out at three-month follow-up after the surgery it is apparent that the effectiveness of both surgical procedures are comparable. However, further follow-up is necessary for a definitive assessment of both methods.

• Klíčová slova
• chirurgická léčba, minisling,
• MeSH
• dospělí MeSH
• interpretace statistických dat MeSH
• lidé středního věku MeSH
• lidé MeSH
• miniinvazivní chirurgické výkony metody   využití   MeSH
• mladý dospělý MeSH
• polypropyleny MeSH
• pooperační komplikace MeSH
• prospektivní studie MeSH
• průzkumy a dotazníky MeSH
• randomizované kontrolované studie jako téma MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• spokojenost pacientů MeSH
• statistika jako téma MeSH
• stresová inkontinence moči chirurgie   MeSH
• suburetrální pásky MeSH
• urodynamika MeSH
• urologické chirurgické výkony metody   využití   MeSH
• výsledek terapie MeSH
• výsledky a postupy - zhodnocení (zdravotní péče) MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mladý dospělý MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• srovnávací studie MeSH

INTRODUCTION AND HYPOTHESIS: The aim of this study was to compare the efficacy of the tension-free vaginal tape obturator (TVT-O) and single-incision tension-free vaginal tape (Ajust™) in the treatment of stress urinary incontinence in a randomized two-arm study with a 1-year follow-up. METHODS: This single-centre randomized trial compared the objective and subjective cure rates of TVT-O and Ajust using objective criteria (cough test) and subjective criteria (International Consultation on Incontinence Questionnaire short form, ICIQ-UI SF). The objective cure rate was defined as the number of patients with a negative cough stress test. Subjective cure was defined as no stress leakage of urine after surgery based on the ICIQ-UI SF. The primary outcome was to establish differences in objective and subjective cure rates between the TVT-O and Ajust groups. We also compared postoperative pain profiles using a visual analogue scale (VAS), improvement in quality of life using the ICIQ- UI SF and the Incontinence Quality of Life questionnaire, and overall satisfaction with the surgical procedure using a VAS and a five-item Likert scale. Inclusion criteria were age over 18 years, signed informed consent, and urodynamic stress urinary incontinence. Following a power calculation, 50 patients were enrolled into each group (Ajust and TVT-O). RESULTS: The mean follow-up after surgery was 445 days (SD 157.6 days) in the TVT-O group and 451.8 days (SD 127.6 days) in the Ajust group (p = 76.6 %). At 1 year, 47 patients were evaluated in the TVT-O group and 49 in the Ajust group. No differences in subjective cure rates or objective cure rates were observed. In the Ajust and TVT-O groups, the rates for no subjective stress leakage were 89.8 % and 91.5 %, respectively (p = 1.0, OR 1.22, 95 % CI 0.24 - 6.58), and the rates for a negative stress test were 89.8 % and 87.2 %, respectively (p = 0.76, OR 0.77, 95 % CI 0.17 - 3.32). In the Ajust group two patients reported de novo pain during sexual intercourse. CONCLUSIONS: After a 1-year-follow-up, no significant differences were found with regard to subjective and objective outcomes between the single-incision tape Ajust and TVT-O.

• MeSH
• časové faktory MeSH
• dospělí MeSH
• kvalita života MeSH
• lidé středního věku MeSH
• lidé MeSH
• následné studie MeSH
• pooperační bolest MeSH
• předoperační péče MeSH
• průzkumy a dotazníky MeSH
• senioři MeSH
• stresová inkontinence moči chirurgie   MeSH
• suburetrální pásky * MeSH
• urologické chirurgické výkony metody   MeSH
• výsledek terapie MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• randomizované kontrolované studie MeSH