Midurethral Synthetic Tape With Tension Control Mechanism Versus Midurethral Free Tape

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

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.

Study Overview

• Status: Unknown
• Conditions: Urinary Stress Incontinence
• Intervention / Treatment: 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
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 127473
    • Recruiting
    • Moscow state university of medicine and dentistry named after A.I. Evdokimov
    • Contact: George Kasyan; Phone Number: +7(915)464-33-18; Email: urodep@msmsu.ru
    • Principal Investigator: George Kasyan
    • Sub-Investigator: Dmitriy Pushkar
    • Sub-Investigator: Sergei Sukhikh
    • Sub-Investigator: Lyudmila Potapova

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Midurethral synthetic tape with tension control mechanism	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.
Active Comparator: midurethral tension free tape	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Moscow State University of Medicine and Dentistry

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Anticipated): October 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: June 14, 2019
• First Submitted That Met QC Criteria: September 23, 2019
• First Posted (Actual): September 24, 2019

Study Record Updates

• Last Update Posted (Actual): September 24, 2019
• Last Update Submitted That Met QC Criteria: September 23, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: complications; stress urinary incontinence; midurethral tension free tape; patient reported outcome; bladder outlet obstruction; tension control mechanism
• Additional Relevant MeSH Terms: Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Urinary Incontinence; Urinary Incontinence, Stress
• Other Study ID Numbers: MoscowSUMD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No