Midurethral Synthetic Tape With Tension Control Mechanism Versus Midurethral Free Tape

Moscow State University of Medicine and Dentistry

Status

Unknown

Conditions

Urinary Stress Incontinence

Treatments

Procedure: surgical management of stress urinary incontinence with synthetic tape with tension control mechanism.

Procedure: surgical management of stress urinary incontinence with midurethral tension free tape.

Study type

Interventional

Funder types

Other

Identifiers

NCT04101279

MoscowSUMD

Details and patient eligibility

About

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.

Enrollment

120 estimated patients

Sex

Female

Ages

21 to 80 years old

Volunteers

No Healthy Volunteers

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