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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Midurethral synthetic tape with tension control mechanism | Experimental |
| |
| midurethral tension free tape | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| surgical management of stress urinary incontinence with midurethral tension free tape. | Procedure | Standard protocol for the surgical treatment of stress urinary incontinence using a transobturator approach. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient 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. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year |
| Stress cough test measured before and after surgery. |
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Inclusion Criteria:
Women suffering from stress urinary incontinence, mixed urinary incontinence with prevalence stress urinary incontinence
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lyudmila Potapova | Contact | +7(915)248-30-20 | urodep@msmsu.ru | |
| Sergei Sukhikh | Contact | +7(985)307-74-50 | clinicaltrails@msmsu.ru |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moscow state university of medicine and dentistry named after A.I. Evdokimov | Recruiting | Moscow | 127473 | Russia |
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Randomized controlled comparative study
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| surgical management of stress urinary incontinence with synthetic tape with tension control mechanism. | Procedure | 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. |
|
Objective cure rate will be not the leakage at physical examination cough test with full bladder (200-400ml) |
| 1 year |
| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| D001748 | Urinary Bladder Neck Obstruction |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014524 | Urethral Obstruction |
| D014522 | Urethral Diseases |
| D001745 | Urinary Bladder Diseases |
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