Urinary Stress Incontinence
Conditions
Keywords
stress urinary incontinence, midurethral tension free tape, patient reported outcome, bladder outlet obstruction, complications, tension control mechanism
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.
Interventions
PROCEDUREsurgical management of stress urinary incontinence with midurethral tension free tape.
Standard protocol for the surgical treatment of stress urinary incontinence using a transobturator approach.
PROCEDUREsurgical management of stress urinary incontinence with synthetic tape with tension control mechanism.
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.
Sponsors
Moscow State University of Medicine and Dentistry
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized controlled comparative study
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient reported outcome measured as urogenital distress inventory (UDI-6) will be assessed before and after surgery at 12 weeks and 1 year. | 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
| Measure | Time frame | Description |
|---|---|---|
| Bladder outlet obstruction measured during urodynamics pressure flow study | 1 year | When the urodynamic research indicators deviate (Qmax \< 12 ml/s and Postvoid residual volume (PVR) \> 100 ml, we establish a diagnosis bladder outlet obstruction. |
| Stress cough test measured before and after surgery. | 1 year | Objective cure rate will be not the leakage at physical examination cough test with full bladder (200-400ml) |
Countries
Russia
Contacts
Primary ContactLyudmila Potapova
Backup ContactSergei Sukhikh
Outcome results
None listed