Suburethral Synthetic Adjustment-controlled Tape Compared with Conventional Treatment for Female Stress Urinary Incontinence: A Randomized Controlled Trial.

Background: Urinary incontinence (UI) is a urological problem in women. Currently, suburethral slings are the standard of surgical treatment for stress UI in the female population.

Objective: To prove the feasibility of an operating technique using suburethral adjustment-controlled tape (SACT) placement.

Design, Setting, And Participants: A single-center comparative randomized controlled trial included patients randomized according to the CONSORT checklist from April to October 2018 and from November 2018 to April 2019. The inclusion criteria were women from 21 to 81 yr, stress and mixed UI forms, and positive cough test. The exclusion criteria were pregnancy, lactation, neurogenic bladder dysfunction, recurrent forms of UI, radiation therapy and pelvic surgery in anamnesis, genital prolapse (Pelvic Organ Prolapse Quantification system >2), urinary infection, and obstructive urination.

Intervention: The first group (50 patients) was using synthetic SACT and the second group (75 patients) a transobturator tape (TOT) midurethral sling (MUS).

Outcome Measurements And Statistical Analysis: Subjective efficacy of 96% was established in group 1 and 86% in group 2, with a median follow-up of 12 mo. According to gynecological examination results, the objective surgical treatment efficiency was 96% in group 1 and 90.7% in group 2. This statistically significant indicator was evaluated in each group. However, when comparing both groups, no statistical difference was revealed. According to urodynamic studies, 1 mo after surgery in group 1, terminal and phase detrusor overactivity signs were 18% (n = 9) and 12% (n = 6), respectively. In group 2, these were 14.7% (n = 11) and 12% (n = 9), respectively.

Results And Limitations: The block approach was used to randomize patients into groups. A total of 125 patients (50 in the main group and 75 in the control group) were analyzed.

Conclusions: Our results prove the efficacy and safety of SACT in treating UI in women. The subjective and objective effectiveness results of treating patients in the study group show the possibility of using SACT in the same row with TOT MUS.

Patient Summary: Our purpose was to standardize the surgery stage for urinary incontinence, and evaluate the effectiveness and safety of suburethral adjustment-controlled tape placement. We analyzed women with urinary incontinence and used two different surgical methods. Our results prove the efficacy and safety of suburethral adjustment-controlled tape in treating urinary incontinence in women.