European journal of obstetrics, gynecology, and reproductive biology · 2016
Nonabsorbable urethral bulking agent - clinical effectiveness and late complications rates in the treatment of recurrent stress urinary incontinence after 2 years of follow-up.
Clinical StudyСтатьяНазвание и аннотация: Перевод пока не подготовлен
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Futyma Konrad, Nowakowski Łukasz, Gałczyński Krzysztof, Miotła Paweł, Rechberger Tomasz
Аннотация
OBJECTIVE: Those patients who failed to achieve continence after a procedure aimed to correct it, require a special attitude and precise management due to the sophisticated anatomical and functional field of interest. The purpose of the present study was to assess long-term clinical efficacy and evaluate the frequency and severity of any complications related to recurrent stress urinary incontinence treatment with a non-absorbable bulking agent periurethral injections.
STUDY DESIGN: Between February 2012-September 2013, 66 patients with recurrent stress urinary incontinence were treated with Urolastic in the tertiary referral gynecologic department. The efficacy of the procedure was assessed objectively at each follow-up visit, scheduled at two, six weeks and 3, 6, 12 and 24 months after primary procedure. Material was injected under local anesthesia according to the manufacturer's instructions, at 10, 2, 4 and 8 o'clock positions with 0.5-1.25ccm per spot. Statistical analyses were performed with Statistica package version 8.0 (StatSoft Inc., Tulsa, OK, USA). A p value <0.05 was considered statistically significant.
RESULTS: Objective success rate at 24 months was found in 32.7% of patients, including 22.4% patients who were completely dry. The efficacy of Urolastic, when considering the intention to treat, is 24.2% and 16.7%, respectively. In 4.5% patients an oval shaped material was found inside the bladder. Overall, complications were observed in 17 (25.8%) patients.
CONCLUSIONS: Although only 30% of patients will benefit from Urolastic injection on the long-term basis it seems to be a safe procedure in the treatment of recurrent stress urinary incontinence.
STUDY DESIGN: Between February 2012-September 2013, 66 patients with recurrent stress urinary incontinence were treated with Urolastic in the tertiary referral gynecologic department. The efficacy of the procedure was assessed objectively at each follow-up visit, scheduled at two, six weeks and 3, 6, 12 and 24 months after primary procedure. Material was injected under local anesthesia according to the manufacturer's instructions, at 10, 2, 4 and 8 o'clock positions with 0.5-1.25ccm per spot. Statistical analyses were performed with Statistica package version 8.0 (StatSoft Inc., Tulsa, OK, USA). A p value <0.05 was considered statistically significant.
RESULTS: Objective success rate at 24 months was found in 32.7% of patients, including 22.4% patients who were completely dry. The efficacy of Urolastic, when considering the intention to treat, is 24.2% and 16.7%, respectively. In 4.5% patients an oval shaped material was found inside the bladder. Overall, complications were observed in 17 (25.8%) patients.
CONCLUSIONS: Although only 30% of patients will benefit from Urolastic injection on the long-term basis it seems to be a safe procedure in the treatment of recurrent stress urinary incontinence.
Предметные рубрики MeSH
AgedCombined Modality TherapyDimethylpolysiloxanesDrug ImplantsFemaleFollow-Up StudiesHumansIntention to Treat AnalysisLost to Follow-UpMiddle AgedObstetrics and Gynecology Department, HospitalParityPolandPostoperative ComplicationsRiskSecondary PreventionSeverity of Illness IndexSuburethral SlingsTertiary Care CentersTitaniumUrethraUrinary Incontinence, StressUrological Agents