Laparoscopic Extraperitoneal ( Modified) Burch Colposuspension

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-17

Study Completion Date

2023-07-30

Brief Summary

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Urinary incontinence is a very common problem in women and can be seen at any age. Laparoscopic burch operation has been shown to be an effective, convenient and safe method in women with stress incontinence. Laparoscopic Burch operation is less invasive because it is advantageous in terms of hospitalization time, blood loss, pain and recovery time, but the disadvantage is the procedure time. Modified extraperitoneal technique may be a good method for lowering the procedure time.

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Detailed Description

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In the research; The pre- and postoperative urodynamics of patients who underwent laparoscopic extraperitoneal (modified) burch operation in the Gynecology and Obstetrics Clinic of Istanbul Health Sciences University Gaziosmanpasa Training and Research Hospital will be compared. Surgical outcomes together with complications will also be assessed.

In addition, the QUALITY OF LIFE (SF36), which determines the quality of life of the patients related to the urinary system functions, and the UROGENITAL DISTRESS INVENTORY (UDI - 6), INCONTINENCE IMPACT QUESTIONNAIRE (IIQ-7) questionnaires that determine the effects of urinary incontinence, will be assessed preoperatively and postoperative 6 months of the patients.

Conditions

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Stress Incontinence, Female

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Normally patients with stress urinary incontinence undergoes laparoscopic burch operation if transvaginal sling surgery was not planned. Here in our study group the assigned surgery type applied to study group is extraperitoneal ( modified) burch operation which is performed by not interfering with the abdominal cavity. By the way our study is an interventional study and it is planned to discuss both the anatomic and functional results of this technique.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patients undergone Laparoscopic Extraperitoneal Burch Colposuspension

Group Type OTHER

Quality of Life QUESTIONNAIRE (SF36)

Intervention Type PROCEDURE

Units of a scale of the patients will be compared pre and postoperatively by using SF36

INCONTINENCE IMPACT QUESTIONNAIRE (IIQ-7)

Intervention Type PROCEDURE

Units of a scale of the patients will be compared pre and postoperatively by using IIQ-7

UROGENITAL DISTRESS INVENTORY (UDI - 6)

Intervention Type PROCEDURE

Units of a scale of the patients will be compared pre and postoperatively by using UDI - 6

Interventions

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Quality of Life QUESTIONNAIRE (SF36)

Units of a scale of the patients will be compared pre and postoperatively by using SF36

Intervention Type PROCEDURE

INCONTINENCE IMPACT QUESTIONNAIRE (IIQ-7)

Units of a scale of the patients will be compared pre and postoperatively by using IIQ-7

Intervention Type PROCEDURE

UROGENITAL DISTRESS INVENTORY (UDI - 6)

Units of a scale of the patients will be compared pre and postoperatively by using UDI - 6

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* having stress urinary incontinence

Exclusion Criteria

* having any kind of urogynecological surgery history
* having pelvic mass
* having endometrial or myometrial pathology
* having uterine prolapsus grater than grade 2
* benign obese

Minimum Eligible Age

25 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes