Laparoscopic Extraperitoneal ( Modified) Burch Colposuspension

June 2, 2023 updated by: Süleyman Salman, Gaziosmanpasa Research and Education Hospital

Evaluation of the Results of Laparoscopic Extraperitoneal ( Modified) Burch

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Recruiting
        • Gaziosmanpasa Training and Research Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Patients undergone Laparoscopic Extraperitoneal Burch Colposuspension
Procedure: Quality of Life QUESTIONNAIRE (SF36)
Units of a scale of the patients will be compared pre and postoperatively by using SF36
Procedure: INCONTINENCE IMPACT QUESTIONNAIRE (IIQ-7)
Units of a scale of the patients will be compared pre and postoperatively by using IIQ-7
Procedure: UROGENITAL DISTRESS INVENTORY (UDI - 6)
Units of a scale of the patients will be compared pre and postoperatively by using UDI - 6

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gaziosmanpasa Research and Education Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2023

Primary Completion (Estimated)

July 17, 2023

Study Completion (Estimated)

July 30, 2023

Study Registration Dates

First Submitted

January 27, 2023

First Submitted That Met QC Criteria

March 3, 2023

First Posted (Actual)

March 14, 2023

Study Record Updates

Last Update Posted (Actual)

June 5, 2023

Last Update Submitted That Met QC Criteria

June 2, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GaziosmanpasaTREHz

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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