Tension-free-vaginal-tape-obturator (TVTO) Versus Tension-free-vaginal-tape-Secur (TVTS) for Treatment of SUI
This study is currently recruiting participants.
Verified July 2011 by Western Galilee Hospital-Nahariya
Sponsor:
Western Galilee Hospital-Nahariya
Information provided by:
Western Galilee Hospital-Nahariya
ClinicalTrials.gov Identifier:
NCT01392651
First received: June 27, 2011
Last updated: July 23, 2011
Last verified: July 2011
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Purpose
Women with urinary stress incontinence who underwent surgical treatment by either TVTO or TVTS will be enrolled. The investigators will collect data from charts and use a telephone questionnaire to check the outcome of these women. Physical examination findings will also be incorporated.
| Condition |
|---|
|
Urinary Stress Incontinence |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Retrospective |
| Official Title: | Outcome of Treatment of Women With Urinary Stress Incontinence Treated by Tension-free-vaginal-tape-obturator (TVTO) Compared to Tension-free-vaginal-tape-Secur (TVTS) |
Resource links provided by NLM:
Further study details as provided by Western Galilee Hospital-Nahariya:
Primary Outcome Measures:
- Prevention of stress incontinence [ Time Frame: 12 months ] [ Designated as safety issue: No ]We will collect data from the files, question the women for possible urinary stress incontinence after one month, 6 months and 12 months after surgery. Data of physical examination will also be incorporated.
Secondary Outcome Measures:
- Evaluation of side effects: tape erosion, pain, bleeding [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]We will question the women for possible pain, bleeding or vaginal discharge. The data on physical examination will be taken from the file.
| Estimated Enrollment: | 120 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Women with urinary stress incontinence |
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 stress urinary incontinence who underwent surgery, by TVT methos, either TVTO or TVTS.
Criteria
Inclusion Criteria:
- Women with USI who underwent TVTS or TVTO procedure, more than 6 months ago
Exclusion Criteria:
- Women who have not undergone TVT procedure
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01392651
Contacts
| Contact: Menahem Neuman, MD | 0546444033 | mneuman@netvision.net.il |
Locations
| Israel | |
| Department of Obstetrics and Gynecology, Western Galilee Hospital | Recruiting |
| Nahariya, Israel | |
| Sub-Investigator: Jacob Bornstein, MD, MPA | |
| Sub-Investigator: Vladimir Sosnovsky, MD | |
| Sub-Investigator: Rene Tendler, MD | |
| Sub-Investigator: Mohamed Kais, MD | |
| Clinics of Dr Neuman | Recruiting |
| Rishon Lezion, Israel | |
Sponsors and Collaborators
Western Galilee Hospital-Nahariya
More Information
No publications provided
| Responsible Party: | Dr. Menahem Neuman, Dpt. Obstetrics & Gynecology, Western Galilee Hospital, Nahariya, Israel |
| ClinicalTrials.gov Identifier: | NCT01392651 History of Changes |
| Other Study ID Numbers: | 920090039 |
| Study First Received: | June 27, 2011 |
| Last Updated: | July 23, 2011 |
| Health Authority: | Israel: Ministry of Health |
Keywords provided by Western Galilee Hospital-Nahariya:
|
Urinary stress incontinence TVT |
Additional relevant MeSH terms:
|
Urinary Incontinence, Stress Urinary Incontinence Urination Disorders |
Urologic Diseases Urological Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on May 22, 2013