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Laparoscopic Extraperitoneal ( Modified) Burch Colposuspension

Primary Purpose

Stress Incontinence, Female

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Quality of Life QUESTIONNAIRE (SF36)
INCONTINENCE IMPACT QUESTIONNAIRE (IIQ-7)
UROGENITAL DISTRESS INVENTORY (UDI - 6)
Sponsored by
Gaziosmanpasa Research and Education Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Incontinence, Female

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)FemaleAccepts 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

Sites / Locations

  • Gaziosmanpasa Training and Research HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patients undergone Laparoscopic Extraperitoneal Burch Colposuspension

Arm Description

Outcomes

Primary Outcome Measures

Surgical outcomes
Operation time in minutes
Surgical outcomes
Bleeding volume in milliliter
Preoperative and postoperative urodynamic result
First sensation of fluid filled in bladder in milliliter will be compared.
Preoperative and postoperative urodynamic result
First urge sensation due to fluid filled in bladder in milliliter will be compared.
Preoperative and postoperative urodynamic result
Maximum cystometric capacity in milliliter will be compared.
Preoperative and postoperative urodynamic result
Compliance in milliliter/cmH2O will be compared.
Preoperative and postoperative urodynamic result
Q max in milliliter/second will be compared.
Preoperative and postoperative urodynamic result
Voided volume of the patients in milliliter will be compared.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
January 27, 2023
Last Updated
June 2, 2023
Sponsor
Gaziosmanpasa Research and Education Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05768607
Brief Title
Laparoscopic Extraperitoneal ( Modified) Burch Colposuspension
Official Title
Evaluation of the Results of Laparoscopic Extraperitoneal ( Modified) Burch
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 17, 2023 (Actual)
Primary Completion Date
July 17, 2023 (Anticipated)
Study Completion Date
July 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gaziosmanpasa Research and Education Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Incontinence, Female

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients undergone Laparoscopic Extraperitoneal Burch Colposuspension
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Quality of Life QUESTIONNAIRE (SF36)
Intervention Description
Units of a scale of the patients will be compared pre and postoperatively by using SF36
Intervention Type
Procedure
Intervention Name(s)
INCONTINENCE IMPACT QUESTIONNAIRE (IIQ-7)
Intervention Description
Units of a scale of the patients will be compared pre and postoperatively by using IIQ-7
Intervention Type
Procedure
Intervention Name(s)
UROGENITAL DISTRESS INVENTORY (UDI - 6)
Intervention Description
Units of a scale of the patients will be compared pre and postoperatively by using UDI - 6
Primary Outcome Measure Information:
Title
Surgical outcomes
Description
Operation time in minutes
Time Frame
1 year
Title
Surgical outcomes
Description
Bleeding volume in milliliter
Time Frame
1 year
Title
Preoperative and postoperative urodynamic result
Description
First sensation of fluid filled in bladder in milliliter will be compared.
Time Frame
1 year
Title
Preoperative and postoperative urodynamic result
Description
First urge sensation due to fluid filled in bladder in milliliter will be compared.
Time Frame
1 year
Title
Preoperative and postoperative urodynamic result
Description
Maximum cystometric capacity in milliliter will be compared.
Time Frame
1 year
Title
Preoperative and postoperative urodynamic result
Description
Compliance in milliliter/cmH2O will be compared.
Time Frame
1 year
Title
Preoperative and postoperative urodynamic result
Description
Q max in milliliter/second will be compared.
Time Frame
1 year
Title
Preoperative and postoperative urodynamic result
Description
Voided volume of the patients in milliliter will be compared.
Time Frame
1 year
Title
Preoperative and postoperative Quality of life Questionnaire
Description
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.
Time Frame
1 year
Title
Preoperative and postoperative UROGENITAL DISTRESS INVENTORY
Description
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.
Time Frame
1 year
Title
Preoperative and postoperative INCONTINENCE IMPACT QUESTIONNAIRE
Description
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.
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Suleyman Salman
Phone
+905059345470
Email
sleymansalman@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Fatma Ketenci Gencer
Phone
05416116469
Email
fathma_k@hotmail.com
Facility Information:
Facility Name
Gaziosmanpasa Training and Research Hospital
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suleyman Salman
Phone
+905059345470
Email
sleymansalman@gmail.com
First Name & Middle Initial & Last Name & Degree
Fatma Ketenci Gencer
Phone
+905416116469
Email
fathma_k@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Laparoscopic Extraperitoneal ( Modified) Burch Colposuspension

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