Impact of Urethral Mobility on the Success of Sling Operations

Not Applicable

• Conditions: Urinary Incontinence
• Interventions: Procedure: Urinary incontience surgery; Drug: 300 cc saline

• Registration Number: NCT02301013
• Lead Sponsor: Kanuni Sultan Suleyman Training and Research Hospital

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.

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.

Study Timeline

• Study Start: 2013-03
• Status Verified: 2014-11
• Study First Submitted: 2014-11-21
• Study First Submitted QC: 2014-11-24
• Last Update Submitted: 2014-11-24
• Study First Posted: 2014-11-25
• Last Update Posted: 2014-11-25
• Primary Completion: 2015-01
• Study Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 140

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Urinary incontience surgery	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 .
Urinary incontience surgery	300 cc saline	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 .

Primary Outcome Measures

Name	Time	Method
Subjective Success of Sling Operations	6 months	Patients whose postoperative UDI-6 and IIQ-7 scores lower than 10 will described as success of sling operations

Secondary Outcome Measures

Name	Time	Method
Objective Success of Sling Operations	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''.

Trial Locations

Locations (1)

Kanuni Sultan Suleyman Training and Research Hospital; 🇹🇷 Istanbul, Kucukcekmece, Turkey