NCT02301013

Impact of Urethral Mobility on the Success of Sling Operations

Are Unsatisfying Results After TVT and TOT Operations Associated With Increased Urethral Mobility

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Kanuni Sultan Suleyman Training and Research Hospital · Academic / Other
• Sex: Female
• Age: 25 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urinary Incontinence

Interventions

Type	Name	Description
PROCEDURE	Urinary incontience surgery	Surgery for stress or mixed urinary incontience
DRUG	300 cc saline

Timeline

• Start date: 2013-03-01
• Primary completion: 2015-01-01
• Completion: 2015-06-01
• First posted: 2014-11-25
• Last updated: 2014-11-25

Locations

1 site across 1 country: Turkey (Türkiye)