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Sub Urethral Sling With or With Out Anterior Repair

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01246271
First Posted: November 23, 2010
Last Update Posted: November 23, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Tabriz University
  Purpose
There is a concern about choosing adequate surgical options for stress urinary incontinence associated with vaginal prolapsed and still lack of evidence can be observed. In this study we compared primary and secondary outcomes of single or combine surgery for SUI with pelvic organ prolapsed.

Condition
Urinary Incontinence

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: a Retrospective Cohort Recognize the Out Comes of SUS With or Without Anterior Vaginal Repair

Resource links provided by NLM:


Further study details as provided by Tabriz University:

Primary Outcome Measures:
  • Urinary incontinence cure rate according ICIQ-UIsf [ Time Frame: 3 month after surgery ]

Secondary Outcome Measures:
  • morbidity and complication [ Time Frame: 3 month after surgery ]

Enrollment: 98
Study Start Date: February 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Sub urethral sling
sus with anterior vainal wall repair

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   27 Years to 78 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
woman with stress urinary incontinence
Criteria

Inclusion Criteria:

  1. Patients must be female
  2. Subjective evidence of stress predominant symptoms on symptom specific questionnaire
  3. Stress incontinence on urodynamics
  4. Patients must be capable of filling in the symptom diary
  5. Prolapse beyond the introitus

Exclusion Criteria:

  1. Patients who are medically unfit to undergo surgical intervention.
  2. Patients who have undergone previous continence surgery
  3. Patients with voiding dysfunction
  4. Patients with recurrent urinary tract infection
  5. Patients who are not sure that their family is complete
  Contacts and Locations
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): NCT01246271


Locations
Iran, Islamic Republic of
Urology department Imam Reza Hospital
Tabriz, Iran, Islamic Republic of
Sponsors and Collaborators
Tabriz University
  More Information

Responsible Party: Fatemeh Sadeghi Ghyassi, Iranian Center for EBM
ClinicalTrials.gov Identifier: NCT01246271     History of Changes
Other Study ID Numbers: 89-234
8948 ( Other Identifier: Tabriz University of Medical Sciences )
First Submitted: November 19, 2010
First Posted: November 23, 2010
Last Update Posted: November 23, 2010
Last Verified: January 2008

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