Laparoscopic Extraperitoneal ( Modified) Burch Colposuspension

Study Overview
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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.

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.

Official Title
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Evaluation of the Results of Laparoscopic Extraperitoneal ( Modified) Burch

Conditions
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Stress Incontinence, Female

Intervention / Treatment
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* Procedure: Quality of Life QUESTIONNAIRE (SF36)
* Procedure: INCONTINENCE IMPACT QUESTIONNAIRE (IIQ-7)
* Procedure: UROGENITAL DISTRESS INVENTORY (UDI - 6)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients undergone Laparoscopic Extraperitoneal Burch Colposuspension<br> | Procedure: Quality of Life QUESTIONNAIRE (SF36)<br>* Units of a scale of the patients will be compared pre and postoperatively by using SF36<br>Procedure: INCONTINENCE IMPACT QUESTIONNAIRE (IIQ-7)<br>* Units of a scale of the patients will be compared pre and postoperatively by using IIQ-7<br>Procedure: UROGENITAL DISTRESS INVENTORY (UDI - 6)<br>* Units of a scale of the patients will be compared pre and postoperatively by using UDI - 6<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical outcomes | Operation time in minutes | 1 year | 
| Surgical outcomes | Bleeding volume in milliliter | 1 year | 
| Preoperative and postoperative urodynamic result | First sensation of fluid filled in bladder in milliliter will be compared. | 1 year | 
| Preoperative and postoperative urodynamic result | First urge sensation due to fluid filled in bladder in milliliter will be compared. | 1 year | 
| Preoperative and postoperative urodynamic result | Maximum cystometric capacity in milliliter will be compared. | 1 year | 
| Preoperative and postoperative urodynamic result | Compliance in milliliter/cmH2O will be compared. | 1 year | 
| Preoperative and postoperative urodynamic result | Q max in milliliter/second will be compared. | 1 year | 
| Preoperative and postoperative urodynamic result | Voided volume of the patients in milliliter will be compared. | 1 year | 
| Preoperative and postoperative Quality of life Questionnaire | The domains assessed were pain, diet, speech, recreation, anxiety, mood, and overall QoL. Patients were asked to choose a Likert scale response (for example, 1 = no pain to 5 = severe pain) to a question on each domain and higher score represents better health. overall score ranges from 6 to 30. Pre and postoperative values will be compared. | 1 year | 
| Preoperative and postoperative UROGENITAL DISTRESS INVENTORY | Score ranges from zero to 18 and higher scores indicate more severe symptoms and INCONTINENCE IMPACT QUESTIONNAIRE (IIQ-7) in which SCORES RANGES FROM 0 TO 21 AND a higher score indicates more severe symptoms and lower quality of life. Pre and postoperative values will be compared. | 1 year | 
| Preoperative and postoperative INCONTINENCE IMPACT QUESTIONNAIRE | Scores ranges from 0 to 21 AND a higher score indicates more severe symptoms and lower quality of life. Pre and postoperative values will be compared. | 1 year |