Evaluation of the Results of Laparoscopic Extraperitoneal ( Modified) Burch
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Surgical outcomes
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 25 Years to 75 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Patients undergone Laparoscopic Extraperitoneal Burch Colposuspension
Intervention: Quality of Life QUESTIONNAIRE (SF36) (Procedure)
Patients undergone Laparoscopic Extraperitoneal Burch Colposuspension
Intervention: INCONTINENCE IMPACT QUESTIONNAIRE (IIQ-7) (Procedure)
Patients undergone Laparoscopic Extraperitoneal Burch Colposuspension
Intervention: UROGENITAL DISTRESS INVENTORY (UDI - 6) (Procedure)
Outcomes
Primary Outcomes
Surgical outcomes
Time Frame: 1 year
Operation time in minutes
Preoperative and postoperative urodynamic result
Time Frame: 1 year
First sensation of fluid filled in bladder in milliliter will be compared.
Preoperative and postoperative UROGENITAL DISTRESS INVENTORY
Time Frame: 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
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Süleyman Salman
Associate Professor
Gaziosmanpasa Research and Education Hospital