Impact of Urethral Mobility on the Success of Sling Operations
Are Unsatisfying Results After TVT and TOT Operations Associated With Increased Urethral Mobility
1 other identifier
interventional
140
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 21, 2014
CompletedFirst Posted
Study publicly available on registry
November 25, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedNovember 25, 2014
November 1, 2014
1.8 years
November 21, 2014
November 24, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Subjective Success of Sling Operations
Patients whose postoperative UDI-6 and IIQ-7 scores lower than 10 will described as success of sling operations
6 months
Secondary Outcomes (1)
Objective Success of Sling Operations
6 months
Study Arms (1)
Urinary incontience surgery
EXPERIMENTALPatients 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 .
Interventions
Surgery for stress or mixed urinary incontience
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kanuni Sultan Suleyman Training and Research Hospital
Istanbul, Kucukcekmece, 34100, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
November 21, 2014
First Posted
November 25, 2014
Study Start
March 1, 2013
Primary Completion
January 1, 2015
Study Completion
June 1, 2015
Last Updated
November 25, 2014
Record last verified: 2014-11