Evaluation of the Effectiveness and Safety of the Midurethral Synthetic Tape With Tension Control Mechanism and Midurethral Tension Free Tape
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Urinary Stress Incontinence
- Sponsor
- Moscow State University of Medicine and Dentistry
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Patient reported outcome measured as urogenital distress inventory (UDI-6) will be assessed before and after surgery at 12 weeks and 1 year.
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Investigators
Gevorg Kasyan
Professor
Moscow State University of Medicine and Dentistry
Eligibility Criteria
Inclusion Criteria
- •Women suffering from stress urinary incontinence, mixed urinary incontinence with prevalence stress urinary incontinence
Exclusion Criteria
- •Pregnancy
- •Women with neurogenic bladder dysfunction
- •Recurrent stress urinary incontinence
- •Woman with history of pelvic surgery
- •Mixed urinary incontinence with prevalence urgency urinary incontinence
- •Women who suffer from advanced POP (POP-Quantification system (POP-Q) stage more than 2)
- •Women with acute urinary tract infection
- •Women with bladder outlet obstruction
- •Women who are not able to give informed consent or participate with this randomized research study for any other reason
Outcomes
Primary Outcomes
Patient reported outcome measured as urogenital distress inventory (UDI-6) will be assessed before and after surgery at 12 weeks and 1 year.
Time Frame: 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.
Secondary Outcomes
- Stress cough test measured before and after surgery.(1 year)
- Bladder outlet obstruction measured during urodynamics pressure flow study(1 year)