Urinary Stress Incontinence Treated by TVTNCT01392664
TVTO Versus TVTFFM for Urinary Stress Incontinence
An observational study of Urinary Stress Incontinence Treated by TVT, run by Western Galilee Hospital-Nahariya at 2 sites in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 95 years, women only
- Conditions the study is for
- Urinary Stress Incontinence Treated by TVT
- How many people
- 200 participants
- Where
- 2 sitesIsrael
- Study dates
- Feb 2009to Jul 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with Urinary Stress Incontinence treated by TVT
Who may be able to join
- Women with Urinary Stress Incontinence treated by TVT
Who cannot join
- Women without with Urinary Stress Incontinence or not treated by TVT
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Department of Obstetrics and Gynecology, Western Galilee Hospital
Nahariya
Clinics of Dr Neuman
Tel Aviv
About this study
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.
Read the 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of urinary stress incontinence
We will question the women as for they have stress urinary incontinence. Physical examination data will also be retrieved.
Measured: One year after surgery
Secondary outcomes (1)
Side effect of surgery
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.
Measured: six-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2011 (estimated)
- Study startFeb 2009
- Primary completionFeb 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Stress Incontinence Treated by TVTStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western Galilee Hospital-Nahariya
- Sponsor type
- Other government
- Responsible party
- Principal investigator, menahem neuman, Western Galilee Hospital-Nahariya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01392664
- Sponsor's protocol ID
- 920090040
- Status last verified
- Jun 2016
- First submitted
- 29 Jun 2011
- Last updated
- 7 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TVTO Versus TVTFFM for Urinary Stress Incontinence
- ClinicalTrials.gov ID
- NCT01392664
- Acronym / sponsor ID
- 920090040
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Western Galilee Hospital-NahariyaOther government
- Study start
- Feb 2009
- Primary completion
- Feb 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 12 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 95 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with Urinary Stress Incontinence treated by TVT
Key inclusion criteria (1 listed)
- Women with Urinary Stress Incontinence treated by TVT
Key exclusion criteria (1 listed)
- Women without with Urinary Stress Incontinence or not treated by TVT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Resolution of urinary stress incontinence
Time frame: One year after surgery
We will question the women as for they have stress urinary incontinence. Physical examination data will also be retrieved.
1 secondary outcome
Side effect of surgery
Time frame: six-12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Stress Incontinence Treated by TVT, run by Western Galilee Hospital-Nahariya at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resolution of urinary stress incontinence (time frame: One year after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2016.