Skip to content

Laparoscopic Extraperitoneal ( Modified) Burch Colposuspension

Evaluation of the Results of Laparoscopic Extraperitoneal ( Modified) Burch

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05768607
Enrollment
90
Registered
2023-03-14
Start date
2023-01-17
Completion date
2023-07-30
Last updated
2023-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress Incontinence, Female

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.

Interventions

PROCEDUREQuality of Life QUESTIONNAIRE (SF36)

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

PROCEDUREINCONTINENCE IMPACT QUESTIONNAIRE (IIQ-7)

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

PROCEDUREUROGENITAL DISTRESS INVENTORY (UDI - 6)

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

Sponsors

Gaziosmanpasa Research and Education Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

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.

Eligibility

Sex/Gender
FEMALE
Age
25 Years to 75 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Surgical outcomes1 yearOperation time in minutes
Preoperative and postoperative urodynamic result1 yearFirst sensation of fluid filled in bladder in milliliter will be compared.
Preoperative and postoperative Quality of life Questionnaire1 yearThe 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 UROGENITAL DISTRESS INVENTORY1 yearScore 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 INCONTINENCE IMPACT QUESTIONNAIRE1 yearScores 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.

Countries

Turkey (Türkiye)

Contacts

Primary ContactSuleyman Salman
sleymansalman@gmail.com+905059345470
Backup ContactFatma Ketenci Gencer
fathma_k@hotmail.com05416116469

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026