Impact of Urethral Mobility on the Success of Sling Operations

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT02301013
• Date of registration: 21/11/2014
• Prospective Registration: No
• Primary sponsor: Kanuni Sultan Suleyman Training and Research Hospital
• Public title: Impact of Urethral Mobility on the Success of Sling Operations
• Scientific title: Are Unsatisfying Results After TVT and TOT Operations Associated With Increased Urethral Mobility
• Date of first enrolment: March 2013
• Target sample size: 140
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT02301013
• Study type: Interventional
• Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Turkey

Contacts

• Name: Agahan Han

Key inclusion & exclusion 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.



Age minimum: 25 Years
Age maximum: 70 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Urinary Incontinence

Intervention(s)

Procedure: Urinary incontience surgery

Drug: 300 cc saline

Primary Outcome(s)

Subjective Success of Sling Operations [Time Frame: 6 months]

Secondary Outcome(s)

Objective Success of Sling Operations [Time Frame: 6 months]

Secondary ID(s)

UM01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors