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Impact of Urethral Mobility on the Success of Sling Operations

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ClinicalTrials.gov Identifier: NCT02301013
Recruitment Status : Unknown
Verified November 2014 by Agahan Han,MD, Kanuni Sultan Suleyman Training and Research Hospital.
Recruitment status was:  Recruiting
First Posted : November 25, 2014
Last Update Posted : November 25, 2014
Sponsor:
Information provided by (Responsible Party):
Agahan Han,MD, 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.


Condition or disease Intervention/treatment Phase
Urinary Incontinence Procedure: Urinary incontience surgery Drug: 300 cc saline Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Are Unsatisfying Results After TVT and TOT Operations Associated With Increased Urethral Mobility
Study Start Date : March 2013
Estimated Primary Completion Date : January 2015
Estimated Study Completion Date : June 2015

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Arm Intervention/treatment
Experimental: 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 .
Procedure: Urinary incontience surgery
Surgery for stress or mixed urinary incontience

Drug: 300 cc saline



Primary Outcome Measures :
  1. Subjective Success of Sling Operations [ Time Frame: 6 months ]
    Patients whose postoperative UDI-6 and IIQ-7 scores lower than 10 will described as success of sling operations


Secondary Outcome Measures :
  1. Objective Success of Sling Operations [ Time Frame: 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''.



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Ages Eligible for Study:   25 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02301013


Locations
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Turkey
Kanuni Sultan Suleyman Training and Research Hospital Recruiting
Istanbul, Kucukcekmece, Turkey, 34100
Contact: Agahan Han    02124041500    agahanhan@hotmail.com   
Sponsors and Collaborators
Kanuni Sultan Suleyman Training and Research Hospital

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Responsible Party: Agahan Han,MD, MD, Kanuni Sultan Suleyman Training and Research Hospital
ClinicalTrials.gov Identifier: NCT02301013     History of Changes
Other Study ID Numbers: UM01
First Posted: November 25, 2014    Key Record Dates
Last Update Posted: November 25, 2014
Last Verified: November 2014

Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders