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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04101279
Other study ID # MoscowSUMD
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 1, 2018
Est. completion date December 2019

Study information

Verified date September 2019
Source Moscow State University of Medicine and Dentistry
Contact Lyudmila Potapova
Phone +7(915)248-30-20
Email urodep@msmsu.ru
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date December 2019
Est. primary completion date October 2019
Accepts healthy volunteers No
Gender Female
Age group 21 Years to 80 Years
Eligibility 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

Study Design


Intervention

Procedure:
surgical management of stress urinary incontinence with midurethral tension free tape.
Standard protocol for the surgical treatment of stress urinary incontinence using a transobturator approach.
surgical 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.

Locations

Country Name City State
Russian Federation Moscow state university of medicine and dentistry named after A.I. Evdokimov Moscow

Sponsors (1)

Lead Sponsor Collaborator
Moscow State University of Medicine and Dentistry

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary 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
Secondary 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) 1 year
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