Midurethral Synthetic Tape With Tension Control Mechanism Versus Midurethral Free Tape

NCT ID: NCT04101279

Last Updated: 2019-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-01

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Urinary Stress Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled comparative study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Midurethral synthetic tape with tension control mechanism

Group Type EXPERIMENTAL

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

Intervention Type 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.

midurethral tension free tape

Group Type ACTIVE_COMPARATOR

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

Intervention Type PROCEDURE

Standard protocol for the surgical treatment of stress urinary incontinence using a transobturator approach.

Interventions

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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.

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Moscow State University of Medicine and Dentistry

OTHER

Sponsor Role lead

Responsible Party

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Gevorg Kasyan

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Moscow state university of medicine and dentistry named after A.I. Evdokimov

Moscow, , Russia

Site Status RECRUITING

Countries

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Russia

Central Contacts

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Lyudmila Potapova

Role: CONTACT

+7(915)248-30-20

Sergei Sukhikh

Role: CONTACT

+7(985)307-74-50

Facility Contacts

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George Kasyan

Role: primary

+7(915)464-33-18

Other Identifiers

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MoscowSUMD

Identifier Type: -

Identifier Source: org_study_id

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