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Midurethral Synthetic Tape With Tension Control Mechanism Versus Midurethral Free Tape

Primary Purpose

Urinary Stress Incontinence

Status

Unknown status

Phase

Not Applicable

Locations

Russian Federation

Study Type

Interventional

Intervention

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

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

About this trial

This is an interventional treatment trial for Urinary Stress Incontinence focused on measuring stress urinary incontinence, midurethral tension free tape, patient reported outcome, bladder outlet obstruction, complications, tension control mechanism

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Midurethral synthetic tape with tension control mechanism

midurethral tension free tape

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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)

Full Information

NCT ID

NCT04101279

First Posted

June 14, 2019

Last Updated

September 23, 2019

Sponsor

Moscow State University of Medicine and Dentistry

1. Study Identification

Unique Protocol Identification Number

NCT04101279

Brief Title

Midurethral Synthetic Tape With Tension Control Mechanism Versus Midurethral Free Tape

Official Title

Evaluation of the Effectiveness and Safety of the Midurethral Synthetic Tape With Tension Control Mechanism and Midurethral Tension Free Tape

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Unknown status

Study Start Date

April 1, 2018 (Actual)

Primary Completion Date

October 2019 (Anticipated)

Study Completion Date

December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Moscow State University of Medicine and Dentistry

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Urinary Stress Incontinence

Keywords

stress urinary incontinence, midurethral tension free tape, patient reported outcome, bladder outlet obstruction, complications, tension control mechanism

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Randomized controlled comparative study

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Midurethral synthetic tape with tension control mechanism

Arm Type

Experimental

Arm Title

midurethral tension free tape

Arm Type

Active Comparator

Intervention Type

Procedure

Intervention Name(s)

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

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

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

Intervention Description

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.

Primary Outcome Measure Information:

Title

Patient reported outcome measured as urogenital distress inventory (UDI-6) will be assessed before and after surgery at 12 weeks and 1 year.

Description

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Bladder outlet obstruction measured during urodynamics pressure flow study

Description

When the urodynamic research indicators deviate (Qmax < 12 ml/s and Postvoid residual volume (PVR) > 100 ml, we establish a diagnosis bladder outlet obstruction.

Time Frame

1 year

Title

Stress cough test measured before and after surgery.

Description

Objective cure rate will be not the leakage at physical examination cough test with full bladder (200-400ml)

Time Frame

1 year

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lyudmila Potapova

Phone

+7(915)248-30-20

urodep@msmsu.ru

First Name & Middle Initial & Last Name or Official Title & Degree

Sergei Sukhikh

Phone

+7(985)307-74-50

clinicaltrails@msmsu.ru

Facility Information:

Facility Name

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

City

Moscow

ZIP/Postal Code

127473

Country

Russian Federation

Individual Site Status

Recruiting

Facility Contact: