OBJECTIVE - The purpose of this study is to evaluate the surgical treatment of stress urinary incontinence by the single incision sling Ophira (Promedon).
DESIGN - Prospective observational study.
SETTING - Department of Obstetrics and Gynaecology, Masaryk University and University Hospital Brno, Brno.
METHODS - Patients with confirmed urodynamic stress urinary incontinence (SUI) were included in the study. Patients with urgent urinary incontinence or mixed incontinence with predominance of urgent folder, patients with insufficiency of internal sphincter of the urethra and pelvic organ prolapse, as well as after previous surgical treatment, patients with pelvic organ prolapse or with other serious pathology of organs of small pelvis were excluded. All patients included in the study received single incision sling (SIS) Ophira (Promedon). The length of the surgery and blood loss and complication was observed. Postoperative observation one year after the treatment was set and evaluated objective and subjective parameters of SUI.
RESULTS - In the study were 138 patients examined, total of 45 (34. 8%) were included. Postoperative observation completed 44 (97. 7%) patients. Mean age was 62. 3 years. The mean follow-up was 12. 9 months, when 40 patients (90. 9%) had a negative cough standardized test (CST). Total of 41 patients (93. 1%) evaluated the operation as a major improvement by using a questionnaire Patient Global Impression of Improvement (PGI-I). Quality of life scores were evaluated by International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF). Before the surgery ranged from 14. 8 ± 2. 5 points, after the surgery 3. 3 ± 2. 0 which is an improvement of 11. 5 ± 3. 1 points. There weren't serious perioperative and postoperative complications.
CONCLUSIONS - Our results are comparable with literary data and are correlated with other studies evaluating the effectiveness of other types of SIS. The method seems to be safe and efficient enough. Observing the group of patients will be continued in order to assess the short- and long-term results.
Ceská gynekologie / Ceská lékarská spolecnost J. Ev. Purkyne. 2015 [Epub]
J Texl, M Huser, I Belkov, M Juráková, R Hudeček, P Janků, I Rejdová, P Ventruba