Sub Urethral Sling With or With Out Anterior Repair

This study has been completed.
Sponsor:
Information provided by:
Tabriz University
ClinicalTrials.gov Identifier:
NCT01246271
First received: November 19, 2010
Last updated: November 22, 2010
Last verified: January 2008
  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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • morbidity and complication [ Time Frame: 3 month after surgery ] [ Designated as safety issue: Yes ]
    -


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

Ages Eligible for Study:   27 Years to 78 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01246271

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

No publications provided

Responsible Party: Fatemeh Sadeghi Ghyassi, Iranian Center for EBM
ClinicalTrials.gov Identifier: NCT01246271     History of Changes
Other Study ID Numbers: 89-234, 8948
Study First Received: November 19, 2010
Last Updated: November 22, 2010
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 21, 2014