Urinary Incontinence Clinical Trial
Official title:
Are Unsatisfying Results After TVT and TOT Operations Associated With Increased Urethral Mobility
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.
Status | Recruiting |
Enrollment | 140 |
Est. completion date | June 2015 |
Est. primary completion date | January 2015 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 25 Years to 70 Years |
Eligibility |
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. |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Turkey | Kanuni Sultan Suleyman Training and Research Hospital | Istanbul | Kucukcekmece |
Lead Sponsor | Collaborator |
---|---|
Kanuni Sultan Suleyman Training and Research Hospital |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes |
Secondary | 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''. | 6 months | Yes |
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