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Laparoscopic Extraperitoneal ( Modified) Burch Colposuspension

G

Gaziosmanpasa Research and Education Hospital

Status

Enrolling

Conditions

Stress Incontinence, Female

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT05768607
GaziosmanpasaTREHz

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 estimated patients

Sex

Female

Ages

25 to 75 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

90 participants in 1 patient group

Patients undergone Laparoscopic Extraperitoneal Burch Colposuspension
Other group
Treatment:
Procedure: INCONTINENCE IMPACT QUESTIONNAIRE (IIQ-7)
Procedure: Quality of Life QUESTIONNAIRE (SF36)
Procedure: UROGENITAL DISTRESS INVENTORY (UDI - 6)

Trial contacts and locations

1

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Central trial contact

Fatma Ketenci Gencer; Suleyman Salman

Data sourced from clinicaltrials.gov

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