Impact of Urethral Mobility on the Success of Sling Operations

Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02301013
• Other study ID #: UM01
• Status: Recruiting
• Phase: N/A
• First received: November 21, 2014
• Last updated: November 24, 2014
• Start date: March 2013
• Est. completion date: June 2015

Study information

• Verified date: November 2014
• Source: Kanuni Sultan Suleyman Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urinary Incontinence

Intervention

Procedure:
• Urinary incontience surgery
Surgery for stress or mixed urinary incontience

Drug:
• 300 cc saline

Locations

Country	Name	City	State
Turkey	Kanuni Sultan Suleyman Training and Research Hospital	Istanbul	Kucukcekmece

Sponsors (1)

Lead Sponsor	Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

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