TVTO Versus TVTFFM for Urinary Stress Incontinence

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
menahem neuman, Western Galilee Hospital-Nahariya
ClinicalTrials.gov Identifier:
NCT01392664
First received: June 29, 2011
Last updated: July 2, 2014
Last verified: July 2011
  Purpose

Women who had urinary stress incontinence and underwent one of two procedures: the classic TVTO or the Folke-Flam method of surgical operation, will be evaluated and compared.


Condition
Urinary Stress Incontinence Treated by TVT

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective

Resource links provided by NLM:


Further study details as provided by Western Galilee Hospital-Nahariya:

Primary Outcome Measures:
  • Resolution of urinary stress incontinence [ Time Frame: One year after surgery ] [ Designated as safety issue: No ]
    We will question the women as for they have stress urinary incontinence. Physical examination data will also be retrieved.


Secondary Outcome Measures:
  • Side effect of surgery [ Time Frame: six-12 months ] [ Designated as safety issue: Yes ]
    We will question the women if they have symptoms such as pain in the hip joints, vaginal discharge and bleeding. Physical examination will be retrieved from the charts.


Enrollment: 200
Study Start Date: February 2009
Study Completion Date: July 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Detailed Description:

We will enroll women that underwent one of the two surgeries: TVTO or the modification where the needle passes somewhat to the side to prevent the post operative pain, for urinary stress incontinence. Data will be collected from the charts. Telephone interviews will be carried out. Physical examination will also be incorporated.

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Women with Urinary Stress Incontinence treated by TVT

Criteria

Inclusion Criteria:

  • Women with Urinary Stress Incontinence treated by TVT

Exclusion Criteria:

  • Women without with Urinary Stress Incontinence or not treated by TVT
  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: NCT01392664

Locations
Israel
Department of Obstetrics and Gynecology, Western Galilee Hospital
Nahariya, Israel
Clinics of Dr Neuman
Tel Aviv, Israel
Sponsors and Collaborators
Western Galilee Hospital-Nahariya
  More Information

No publications provided

Responsible Party: menahem neuman, Principal Investigator, Western Galilee Hospital-Nahariya
ClinicalTrials.gov Identifier: NCT01392664     History of Changes
Other Study ID Numbers: 920090040
Study First Received: June 29, 2011
Last Updated: July 2, 2014
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on October 23, 2014