Laparoscopic Extraperitoneal ( Modified) Burch Colposuspension

Not Applicable

Recruiting

• Conditions: Stress Incontinence, Female
• Interventions: Procedure: Quality of Life QUESTIONNAIRE (SF36); Procedure: INCONTINENCE IMPACT QUESTIONNAIRE (IIQ-7); Procedure: UROGENITAL DISTRESS INVENTORY (UDI - 6)

• Registration Number: NCT05768607
• Lead Sponsor: Gaziosmanpasa Research and Education Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2023-01-17
• Study First Submitted: 2023-01-27
• Study First Submitted QC: 2023-03-03
• Study First Posted: 2023-03-14
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-02
• Last Update Posted: 2023-06-05
• Primary Completion: 2023-07-17
• Study Completion: 2023-07-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients undergone Laparoscopic Extraperitoneal Burch Colposuspension	INCONTINENCE IMPACT QUESTIONNAIRE (IIQ-7)	-
Patients undergone Laparoscopic Extraperitoneal Burch Colposuspension	UROGENITAL DISTRESS INVENTORY (UDI - 6)	-
Patients undergone Laparoscopic Extraperitoneal Burch Colposuspension	Quality of Life QUESTIONNAIRE (SF36)	-

Primary Outcome Measures

Name	Time	Method
Preoperative and postoperative urodynamic result	1 year	Voided volume of the patients in milliliter will be compared.
Surgical outcomes	1 year	Bleeding volume in milliliter
Preoperative and postoperative UROGENITAL DISTRESS INVENTORY	1 year	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.
Preoperative and postoperative Quality of life Questionnaire	1 year	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.
Preoperative and postoperative INCONTINENCE IMPACT QUESTIONNAIRE	1 year	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.

Trial Locations

Locations (1)

Gaziosmanpasa Training and Research Hospital; 🇹🇷 Istanbul, Turkey