TVTO Versus TVTFFM for Urinary Stress Incontinence

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01392664

Enrollment

200

Registered

2011-07-12

Start date

2009-02-28

Completion date

2013-07-31

Last updated

2016-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Stress Incontinence Treated by TVT

Brief summary

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.

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 95 Years

Healthy volunteers

Inclusion criteria

* Women with Urinary Stress Incontinence treated by TVT

Exclusion criteria

* Women without with Urinary Stress Incontinence or not treated by TVT

Design outcomes

Primary

Measure	Time frame	Description
Resolution of urinary stress incontinence	One year after surgery	We will question the women as for they have stress urinary incontinence. Physical examination data will also be retrieved.

Secondary

Measure	Time frame	Description
Side effect of surgery	six-12 months	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.

Countries

Israel

Outcome results