## Protocol Section
### Identification Module
**NCT ID:** 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

#### Organization Study ID Info
**ID:** MoscowSUMD
#### Organization
**Class:** OTHER
**Full Name:** Moscow State University of Medicine and Dentistry
### Status Module
#### Completion Date
**Date:** 2019-12

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2019-09-24

**Type:** ACTUAL

**Last Update Submit Date:** 2019-09-23

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2019-10

**Type:** ESTIMATED

#### Start Date
**Date:** 2018-04-01

**Type:** ACTUAL

**Status Verified Date:** 2019-09

#### Study First Post Date
**Date:** 2019-09-24
**Type:** ACTUAL
**Study First Submit Date:** 2019-06-14
**Study First Submit QC Date:** 2019-09-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Moscow State University of Medicine and Dentistry

#### Responsible Party

**Investigator Affiliation:** Moscow State University of Medicine and Dentistry

**Investigator Full Name:** Gevorg Kasyan

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Urinary Stress Incontinence

**Keywords:**

- stress urinary incontinence

- midurethral tension free tape

- patient reported outcome

- bladder outlet obstruction

- complications

- tension control mechanism

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Randomized controlled comparative study

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 120

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

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

**Label:** Midurethral synthetic tape with tension control mechanism

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

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

**Label:** midurethral tension free tape

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- midurethral tension free tape

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

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

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- Midurethral synthetic tape with tension control mechanism

**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.

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

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

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

**Time Frame:** 1 year

#### Secondary Outcomes

**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.

**Measure:** Bladder outlet obstruction measured during urodynamics pressure flow study

**Time Frame:** 1 year

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

**Measure:** Stress cough test measured before and after surgery.

**Time Frame:** 1 year

### Eligibility Module

**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

**Maximum Age:** 80 Years

**Minimum Age:** 21 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** urodep@msmsu.ru

**Name:** Lyudmila Potapova

**Phone:** +7(915)248-30-20

**Role:** CONTACT

**Contact 2:**

**Email:** clinicaltrails@msmsu.ru

**Name:** Sergei Sukhikh

**Phone:** +7(985)307-74-50

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Moscow

**Contacts:**

***Contact 1:***

- **Email:** urodep@msmsu.ru

- **Name:** George Kasyan

- **Phone:** +7(915)464-33-18

- **Role:** CONTACT

***Contact 2:***

- **Name:** George Kasyan

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 3:***

- **Name:** Dmitriy Pushkar

- **Role:** SUB_INVESTIGATOR

***Contact 4:***

- **Name:** Sergei Sukhikh

- **Role:** SUB_INVESTIGATOR

***Contact 5:***

- **Name:** Lyudmila Potapova

- **Role:** SUB_INVESTIGATOR

**Country:** Russian Federation

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

**Status:** RECRUITING

**Zip:** 127473

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014549

- Term: Urinary Incontinence

- ID: D000014555

- Term: Urination Disorders

- ID: D000014570

- Term: Urologic Diseases

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

- ID: D000059411

- Term: Lower Urinary Tract Symptoms

- ID: D000020924

- Term: Urological Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

### Condition Browse Module - Browse Leaves

- ID: M5029

- Name: Urinary Bladder Neck Obstruction

- Relevance: LOW

- As Found: Unknown

- ID: M17299

- Name: Urinary Incontinence

- Relevance: LOW

- As Found: Unknown

- ID: M7936

- Name: Enuresis

- Relevance: LOW

- As Found: Unknown

- ID: M17300

- Name: Urinary Incontinence, Stress

- Relevance: HIGH

- As Found: Urinary Stress Incontinence

- ID: M17305

- Name: Urination Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M17319

- Name: Urologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M29464

- Name: Lower Urinary Tract Symptoms

- Relevance: LOW

- As Found: Unknown

- ID: M22659

- Name: Urological Manifestations

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000014550

- Term: Urinary Incontinence, Stress

### Misc Info Module

- Version Holder: 2024-05-24
