This is a prospective, comparative randomized controled trial. The general purposes of this study is to compare the efficacy and safety of midurethral synthetic tape with tension control mechanism and conventional midurethral tension free tape as surgical treatment for female urinary stress incontinence.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Standard protocol for the surgical treatment of stress urinary incontinence using a transobturator approach.
Standard protocol for the surgical treatment of stress urinary incontinence using a transobturator approach. A absorbing gasket attached to the middle of the tape provides tension control.
Moscow state university of medicine and dentistry named after A.I. Evdokimov
Moscow, Russia
RECRUITINGPatient reported outcome measured as urogenital distress inventory (UDI-6) will be assessed before and after surgery at 12 weeks and 1 year.
The UDI measures the impact of urinary incontinence on activities, roles, and emotional states in women. This questionnaire presented six questions related to urinary disorders. The patient could answer "Not at all", "A little bit", "Moderately" or "Greatly", to each of the questions, each answer is evaluated at 0, 1, 2 or 3 points, respectively, and then summed up. The final score means that the greater the sum of the indicators, the worse the patient's condition. This score reflects the condition of the patient before and after surgery at 12 weeks and 1 year.
Time frame: 1 year
Bladder outlet obstruction measured during urodynamics pressure flow study
When the urodynamic research indicators deviate (Qmax \< 12 ml/s and Postvoid residual volume (PVR) \> 100 ml, we establish a diagnosis bladder outlet obstruction.
Time frame: 1 year
Stress cough test measured before and after surgery.
Objective cure rate will be not the leakage at physical examination cough test with full bladder (200-400ml)
Time frame: 1 year
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