Urinary RetentionNCT03517202
Duration of Stay After Urologic Surgery : Neuraxial Versus General Anesthesia
An observational study of Urinary Retention, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Outpatient midurethral surgery is a frequent surgery. It is performed either under general anesthesia or neuraxial anesthesia. A frequent complication is postoperative urinary retention requiring urinary catheterization, which implies a higher infectious risk. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Retention
- How many people
- 260 participants
- Where
- 1 siteFrance
- Study dates
- 13 Mar 2018to Jun 2018
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patient undergoing outpatient urinary incontinence surgery using TVT between 2012 and 2016
Who may be able to join
- Age > 18 years
- Sex: Female
- Patient who has consented to the use of her medical data for research purposes.
- Patient undergoing outpatient urinary incontinence surgery using TVT between 2012 and 2016
Who cannot join
- Specific clinical forms of the disease,
- Interfering treatments and associated diseases, history,
- Refusal of the patient to participate in the study
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service d'Anesthésiologie - Réanimation
Strasbourg, 67091
Valentina FAITOT, MD, 33 3 88 12 70 75, valentina.faitot@chru-strasbourg.fr
Gauthier VINEE, MD, 33 3 88 12 70 75, gauthieremmanuel.vinee@chru-strasbourg.fr
About this study
Official title: Duration of Stay for Outpatient Surgery After Tension Free Vaginal Tape (TVT) Urologic Surgery : Neuraxial Versus General Anesthesia
Outpatient midurethral surgery is a frequent surgery. It is performed either under general anesthesia or neuraxial anesthesia. A frequent complication is postoperative urinary retention requiring urinary catheterization, which implies a higher infectious risk.
The investigators compared the complication rate after TVT surgery depending on the type of anesthesia.
- Conditions
- Urinary Retention
- Keywords
- Urologic surgery, Urinary incontinence, Tension Free Vaginal Tape, Post-operative urinary retention, Outpatient surgery
- Medical subject headings
- Urinary Retention, Urinary Incontinence
What is being measured
The primary outcome is the main question the study is designed to answer.
The investigators compared the rate of complications after TVT surgery depending on the type of anesthesia and the need for urinary catheterization, requiring longer hospital stay after surgery.
Patients hospitalized at Strasbourg University Hospital from 2012 to 2016.
Measured: The period from January 1st, 2012 to December 31st, 2016 will be examined
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2018
- Study start13 Mar 2018
- Primary completionJun 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary RetentionStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Retrospective
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valentina FAITOT, MD, Principal investigator, University Hospital, Strasbourg, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03517202
- Sponsor's protocol ID
- 7001
- Status last verified
- Mar 2018
- First submitted
- 24 Apr 2018
- Last updated
- 4 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duration of Stay for Outpatient Surgery After Tension Free Vaginal Tape (TVT) Urologic Surgery : Neuraxial Versus General Anesthesia
- ClinicalTrials.gov ID
- NCT03517202
- Acronym / sponsor ID
- 7001
- Conditions
- Urinary Retention
- Keywords
- Urologic surgery, Urinary incontinence, Tension Free Vaginal Tape, Post-operative urinary retention, Outpatient surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 13 Mar 2018 (actual)
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 7 May 2018 (actual)
- 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.
Outpatient midurethral surgery is a frequent surgery. It is performed either under general anesthesia or neuraxial anesthesia. A frequent complication is postoperative urinary retention requiring urinary catheterization, which implies a higher infectious risk.
The investigators compared the complication rate after TVT surgery depending on the type of anesthesia.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient undergoing outpatient urinary incontinence surgery using TVT between 2012 and 2016
Key inclusion criteria (4 listed)
- Age > 18 years
- Sex: Female
- Patient who has consented to the use of her medical data for research purposes.
- Patient undergoing outpatient urinary incontinence surgery using TVT between 2012 and 2016
Key exclusion criteria (3 listed)
- Specific clinical forms of the disease,
- Interfering treatments and associated diseases, history,
- Refusal of the patient to participate in the study
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
The investigators compared the rate of complications after TVT surgery depending on the type of anesthesia and the need for urinary catheterization, requiring longer hospital stay after surgery.
Time frame: The period from January 1st, 2012 to December 31st, 2016 will be examined
Patients hospitalized at Strasbourg University Hospital from 2012 to 2016.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2018.
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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.
Valentina FAITOT, MD principal investigator
University Hospital, Strasbourg, France
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 Urinary Retention, run by University Hospital, Strasbourg, France at 1 site in France.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 4 Jun 2018. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Valentina FAITOT, MD (03 88 12 70 75, valentina.faitot@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The investigators compared the rate of complications after TVT surgery depending on the type of anesthesia and the need for urinary catheterization, requiring longer hospital stay after surgery. (time frame: The period from January 1st, 2012 to December 31st, 2016 will be examined). 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 4 Jun 2018; AzTrials last refreshed its copy on 8 Nov 2026.