Impact of Urethral Mobility on the Success of Sling Operations
Primary Purpose
Urinary Incontinence
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Urinary incontience surgery
300 cc saline
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Incontinence
Eligibility Criteria
Inclusion Criteria:
- 140 patients will be included in the research who are planned to have TVT and TOT operations with SUI and MUI diagnoses between March 1, 2013 and January 1, 2015 in Kanuni Sultan Suleyman Medical Research and Educational Hospital.
Exclusion Criteria:
- Patients with level 3 or higher level of uterine descensus, previous urinary incontinence surgery, overactive bladder and who are unwilling for randomization will not been included.
Sites / Locations
- Kanuni Sultan Suleyman Training and Research HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Urinary incontience surgery
Arm Description
Patients who is between 25 to 70 years old and positive stress test and have TVT or TOT operations with diagnoses of stress urinary incontinence and mixed urinary incontinence .
Outcomes
Primary Outcome Measures
Subjective Success of Sling Operations
Patients whose postoperative UDI-6 and IIQ-7 scores lower than 10 will described as success of sling operations
Secondary Outcome Measures
Objective Success of Sling Operations
A patient with a bladder filled 300 cc saline will cough and if no leakage of urine,the patient will be described as ''cured''.
Full Information
NCT ID
NCT02301013
First Posted
November 21, 2014
Last Updated
November 24, 2014
Sponsor
Kanuni Sultan Suleyman Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02301013
Brief Title
Impact of Urethral Mobility on the Success of Sling Operations
Official Title
Are Unsatisfying Results After TVT and TOT Operations Associated With Increased Urethral Mobility
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2013 (undefined)
Primary Completion Date
January 2015 (Anticipated)
Study Completion Date
June 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kanuni Sultan Suleyman Training and Research Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Main objective is to evaluate the relation between the increased urethral mobility and unsuccessful treatment after TVT and TOT operations.
140 patients will be included in the research who are planned to have TVT and TOT operations with SUI and MUI diagnoses.Female patients of 25 to 70 years of age who are positive for stress test will be included.
All patients will be questioned for parity, body mass index, menopausal state, medical history, and examined for POP-Q stage, urodynamy, stress test, UDI 6, IIQ7 and with transperineal sonography preoperatively. "Passive mobility angle" and "active mobility angle" will be measured.
The relationship between passive mobility angle or active mobility angle and success of sling operations will be determined in this study.
Detailed Description
Transperineal sonography will be performed in a 300 cc filled bladder state, on a horizon which connects the lower margin of the pubic bone and the lower side of the urethral part of the bladder. First measurement will be done on litotomy position in resting state, second on 45 degrees reverse trandelenburg position in resting state and third one on 45 degrees reverse trandelenburg position in maximal valsalva straining state. The alteration between the angles measured at resting litotomy position and the resting reverse trandelenburg position is named as "passive mobility angle" (trigger gap) and the angle measured between the trigger gap and maximal valsalva state is named as "active mobility angle". Furthermore, post voiding residues have also been measured by transperineal ultrasonography.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Urinary incontience surgery
Arm Type
Experimental
Arm Description
Patients who is between 25 to 70 years old and positive stress test and have TVT or TOT operations with diagnoses of stress urinary incontinence and mixed urinary incontinence .
Intervention Type
Procedure
Intervention Name(s)
Urinary incontience surgery
Intervention Description
Surgery for stress or mixed urinary incontience
Intervention Type
Drug
Intervention Name(s)
300 cc saline
Primary Outcome Measure Information:
Title
Subjective Success of Sling Operations
Description
Patients whose postoperative UDI-6 and IIQ-7 scores lower than 10 will described as success of sling operations
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Objective Success of Sling Operations
Description
A patient with a bladder filled 300 cc saline will cough and if no leakage of urine,the patient will be described as ''cured''.
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
140 patients will be included in the research who are planned to have TVT and TOT operations with SUI and MUI diagnoses between March 1, 2013 and January 1, 2015 in Kanuni Sultan Suleyman Medical Research and Educational Hospital.
Exclusion Criteria:
Patients with level 3 or higher level of uterine descensus, previous urinary incontinence surgery, overactive bladder and who are unwilling for randomization will not been included.
Facility Information:
Facility Name
Kanuni Sultan Suleyman Training and Research Hospital
City
Istanbul
State/Province
Kucukcekmece
ZIP/Postal Code
34100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Agahan Han
Phone
02124041500
Email
agahanhan@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
Impact of Urethral Mobility on the Success of Sling Operations
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