Midurethral Synthetic Tape With Tension Control Mechanism Versus Midurethral Free Tape

Not Applicable

• Conditions: Urinary Stress Incontinence
• Interventions: Procedure: surgical management of stress urinary incontinence with midurethral tension free tape.; Procedure: surgical management of stress urinary incontinence with synthetic tape with tension control mechanism.

• Registration Number: NCT04101279
• Lead Sponsor: Moscow State University of Medicine and Dentistry

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-01
• Study First Submitted: 2019-06-14
• Status Verified: 2019-09
• Study First Submitted QC: 2019-09-23
• Last Update Submitted: 2019-09-23
• Study First Posted: 2019-09-24
• Last Update Posted: 2019-09-24
• Primary Completion: 2019-10
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
midurethral tension free tape	surgical management of stress urinary incontinence with midurethral tension free tape.	-
Midurethral synthetic tape with tension control mechanism	surgical management of stress urinary incontinence with synthetic tape with tension control mechanism.	-

Primary Outcome Measures

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

Name	Time	Method
Bladder outlet obstruction measured during urodynamics pressure flow study	1 year	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.	1 year	Objective cure rate will be not the leakage at physical examination cough test with full bladder (200-400ml)

Trial Locations

Locations (1)

Moscow state university of medicine and dentistry named after A.I. Evdokimov; 🇷🇺 Moscow, Russian Federation