Impact of Urethral Mobility on the Success of Sling Operations
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|ClinicalTrials.gov Identifier: NCT02301013|
Recruitment Status : Unknown
Verified November 2014 by Agahan Han,MD, Kanuni Sultan Suleyman Training and Research Hospital.
Recruitment status was: Recruiting
First Posted : November 25, 2014
Last Update Posted : November 25, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Urinary Incontinence||Procedure: Urinary incontience surgery Drug: 300 cc saline||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||140 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Are Unsatisfying Results After TVT and TOT Operations Associated With Increased Urethral Mobility|
|Study Start Date :||March 2013|
|Estimated Primary Completion Date :||January 2015|
|Estimated Study Completion Date :||June 2015|
Experimental: Urinary incontience surgery
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 .
Procedure: Urinary incontience surgery
Surgery for stress or mixed urinary incontience
Drug: 300 cc saline
- Subjective Success of Sling Operations [ Time Frame: 6 months ]Patients whose postoperative UDI-6 and IIQ-7 scores lower than 10 will described as success of sling operations
- Objective Success of Sling Operations [ Time Frame: 6 months ]A patient with a bladder filled 300 cc saline will cough and if no leakage of urine,the patient will be described as ''cured''.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02301013
|Kanuni Sultan Suleyman Training and Research Hospital||Recruiting|
|Istanbul, Kucukcekmece, Turkey, 34100|
|Contact: Agahan Han 02124041500 email@example.com|