Voiding DysfunctionNCT00713908
Voiding Dysfunction in the Postoperative Period Following Placement of the TVT
An observational study of Voiding Dysfunction, run by University of Rochester at 1 site in United States.
Trial summary
The purpose of this study is to evaluate how often women have problems passing their urine (voiding) after TVT (Tension Free Vaginal Tape) surgery. This will help us to better understand normal voiding function after surgery as well as to find factors that may help us predict who will have problems after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Voiding Dysfunction
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Aug 2009
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Urogynecology clinic
Who may be able to join
- Diagnosis of stress incontinence, diagnosis must be confirmed by cough stress test or multichannel urodynamics
- Undergoing minimally invasive sling procedure - TVT (by transvaginal or surpapubic approach)
- Must be competent to give informed consent
Who cannot join
- No diagnosis of stress urinary incontinence
- Undergoing minimally invasive sling procedure by route other than TVT
- Undergoing any other pelvic organ prolapse repair procedures
- Pregnancy
- Known voiding dysfunction preoperatively
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate how often women have problems passing their urine (voiding) after TVT (Tension Free Vaginal Tape) surgery. This will help us to better understand normal voiding function after surgery as well as to find factors that may help us predict who will have problems after surgery.
- Conditions
- Voiding Dysfunction
- Keywords
- Voiding dysfunction following TVT placement
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-void residual volume
Measured: Pre-operative and post-operative periods
Secondary outcomes (1)
2-day voiding diary, uroflow, standardized questionnaires
Measured: Pre-operatively and post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2008 (estimated)
- Study startNov 2007
- Primary completionAug 2009
- Study completionAug 2009
Why it stopped: The Co-Principal Investigator has moved and is no longer interested in continuing this study at this site.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Voiding DysfunctionStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Investigators
- Michael K. Flynn, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00713908
- Sponsor's protocol ID
- 20430
- Status last verified
- Dec 2009
- First submitted
- 8 Jul 2008
- Last updated
- 16 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Voiding Dysfunction in the Postoperative Period Following Placement of the TVT
- ClinicalTrials.gov ID
- NCT00713908
- Acronym / sponsor ID
- 20430
- Conditions
- Voiding Dysfunction
- Keywords
- Voiding dysfunction following TVT placement
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The Co-Principal Investigator has moved and is no longer interested in continuing this study at this site.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 14 Jul 2008 (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.
The purpose of this study is to evaluate how often women have problems passing their urine (voiding) after TVT (Tension Free Vaginal Tape) surgery. This will help us to better understand normal voiding function after surgery as well as to find factors that may help us predict who will have problems after surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Urogynecology clinic
Key inclusion criteria (3 listed)
- Diagnosis of stress incontinence, diagnosis must be confirmed by cough stress test or multichannel urodynamics
- Undergoing minimally invasive sling procedure - TVT (by transvaginal or surpapubic approach)
- Must be competent to give informed consent
Key exclusion criteria (5 listed)
- No diagnosis of stress urinary incontinence
- Undergoing minimally invasive sling procedure by route other than TVT
- Undergoing any other pelvic organ prolapse repair procedures
- Pregnancy
- Known voiding dysfunction preoperatively
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
Post-void residual volume
Time frame: Pre-operative and post-operative periods
1 secondary outcome
2-day voiding diary, uroflow, standardized questionnaires
Time frame: Pre-operatively and post-operatively
Results and safety
The study was stopped early (reason given: The Co-Principal Investigator has moved and is no longer interested in continuing this study at this site.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2009.
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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.
Michael K. Flynn, MD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Voiding Dysfunction, run by University of Rochester at 1 site in United States.
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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 16 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 was stopped early (reason given: The Co-Principal Investigator has moved and is no longer interested in continuing this study at this site.). Results are not available in the source record.
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?
Post-void residual volume (time frame: Pre-operative and post-operative periods). 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 16 Dec 2009.