NCT04101279

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 14, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 24, 2019

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

September 24, 2019

Status Verified

September 1, 2019

Enrollment Period

1.5 years

First QC Date

June 14, 2019

Last Update Submit

September 23, 2019

Conditions

Urinary Stress Incontinence

Keywords

stress urinary incontinencemidurethral tension free tapepatient reported outcomebladder outlet obstructioncomplicationstension control mechanism

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Bladder outlet obstruction measured during urodynamics pressure flow study

    1 year

  • Stress cough test measured before and after surgery.

    1 year

Study Arms (2)

Midurethral synthetic tape with tension control mechanism

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

midurethral tension free tape

ACTIVE COMPARATOR
Procedure: surgical management of stress urinary incontinence with midurethral tension free tape.

Interventions

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

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

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

Eligibility Criteria

Age21 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women suffering from stress urinary incontinence, mixed urinary incontinence with prevalence stress urinary incontinence

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Moscow, 127473, Russia

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence, StressUrinary Bladder Neck Obstruction

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsUrethral ObstructionUrethral DiseasesUrinary Bladder Diseases

Central Study Contacts

Lyudmila Potapova

CONTACT

+7(915)248-30-20urodep@msmsu.ru

Sergei Sukhikh

CONTACT

+7(985)307-74-50clinicaltrails@msmsu.ru

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled comparative study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 14, 2019

First Posted

September 24, 2019

Study Start

April 1, 2018

Primary Completion

October 1, 2019

Study Completion

December 1, 2019

Last Updated

September 24, 2019

Record last verified: 2019-09

Locations

RU(1)