Laparoscopic Extraperitoneal ( Modified) Burch Colposuspension

Stress Incontinence, Female Clinical Trial

Official title:

Evaluation of the Results of Laparoscopic Extraperitoneal ( Modified) Burch

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05768607
• Other study ID #: GaziosmanpasaTREHz
• Status: Recruiting
• Phase: N/A
• Start date: January 17, 2023
• Est. completion date: July 30, 2023

Study information

• Verified date: June 2023
• Source: Gaziosmanpasa Research and Education Hospital
• Contact: Suleyman Salman
• Phone: +905059345470
• Email: sleymansalman[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: July 30, 2023
• Est. primary completion date: July 17, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Stress Incontinence, Female
• Urinary Incontinence, Stress

Intervention

Procedure:
• Quality of Life QUESTIONNAIRE (SF36)
Units of a scale of the patients will be compared pre and postoperatively by using SF36
• INCONTINENCE IMPACT QUESTIONNAIRE (IIQ-7)
Units of a scale of the patients will be compared pre and postoperatively by using IIQ-7
• UROGENITAL DISTRESS INVENTORY (UDI - 6)
Units of a scale of the patients will be compared pre and postoperatively by using UDI - 6

Locations

Country	Name	City	State
Turkey	Gaziosmanpasa Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Gaziosmanpasa Research and Education Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical outcomes	Operation time in minutes	1 year
Primary	Surgical outcomes	Bleeding volume in milliliter	1 year
Primary	Preoperative and postoperative urodynamic result	First sensation of fluid filled in bladder in milliliter will be compared.	1 year
Primary	Preoperative and postoperative urodynamic result	First urge sensation due to fluid filled in bladder in milliliter will be compared.	1 year
Primary	Preoperative and postoperative urodynamic result	Maximum cystometric capacity in milliliter will be compared.	1 year
Primary	Preoperative and postoperative urodynamic result	Compliance in milliliter/cmH2O will be compared.	1 year
Primary	Preoperative and postoperative urodynamic result	Q max in milliliter/second will be compared.	1 year
Primary	Preoperative and postoperative urodynamic result	Voided volume of the patients in milliliter will be compared.	1 year
Primary	Preoperative and postoperative Quality of life Questionnaire	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.	1 year
Primary	Preoperative and postoperative UROGENITAL DISTRESS INVENTORY	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.	1 year
Primary	Preoperative and postoperative INCONTINENCE IMPACT QUESTIONNAIRE	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.	1 year