Clinical trial NCT05768607: Laparoscopic Extraperitoneal ( Modified) Burch Colposuspension
Official title: Evaluation of the Results of Laparoscopic Extraperitoneal ( Modified) Burch
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress Incontinence, Female
Lead sponsor: Gaziosmanpasa Research and Education Hospital
Sponsor class: OTHER_GOV
First posted: 2023-03-14
Enrollment: 90
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Surgical outcomes
timeFrame: 1 year
measure: Surgical outcomes
timeFrame: 1 year
measure: Preoperative and postoperative urodynamic result
timeFrame: 1 year
measure: Preoperative and postoperative urodynamic result
timeFrame: 1 year
measure: Preoperative and postoperative urodynamic result
timeFrame: 1 year
measure: Preoperative and postoperative urodynamic result
timeFrame: 1 year
measure: Preoperative and postoperative urodynamic result
timeFrame: 1 year
measure: Preoperative and postoperative urodynamic result
timeFrame: 1 year
measure: Preoperative and postoperative Quality of life Questionnaire
timeFrame: 1 year
measure: Preoperative and postoperative UROGENITAL DISTRESS INVENTORY
timeFrame: 1 year
measure: Preoperative and postoperative INCONTINENCE IMPACT QUESTIONNAIRE
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Gaziosmanpasa Training and Research Hospital
Study officials:
References: