Midurethral Synthetic Tape With Tension Control Mechanism Versus Midurethral Free Tape

Urinary Stress Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04101279
• Other study ID #: MoscowSUMD
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: December 2019

Study information

• Verified date: September 2019
• Source: Moscow State University of Medicine and Dentistry
• Contact: Lyudmila Potapova
• Phone: +7(915)248-30-20
• Email: urodep[@]msmsu.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Urinary Incontinence, Stress
• Urinary Stress Incontinence

Intervention

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.
• 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.

Locations

Country	Name	City	State
Russian Federation	Moscow state university of medicine and dentistry named after A.I. Evdokimov	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Moscow State University of Medicine and Dentistry

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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