NCT03517202

Brief 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. The investigators compared the complication rate after TVT surgery depending on the type of anesthesia.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
260

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 13, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 24, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 7, 2018

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

June 4, 2018

Status Verified

March 1, 2018

Enrollment Period

3 months

First QC Date

April 24, 2018

Last Update Submit

May 31, 2018

Conditions

Urinary Retention

Keywords

Urologic surgeryUrinary incontinenceTension Free Vaginal TapePost-operative urinary retentionOutpatient surgery

Outcome Measures

Primary Outcomes (1)

  • 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.

    The period from January 1st, 2012 to December 31st, 2016 will be examined

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient undergoing outpatient urinary incontinence surgery using TVT between 2012 and 2016

You may qualify if:

  • 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

You may not qualify if:

  • Specific clinical forms of the disease,
  • Interfering treatments and associated diseases, history,
  • Refusal of the patient to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service d'Anesthésiologie - Réanimation

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Urinary RetentionUrinary Incontinence

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Valentina FAITOT, MD

    University Hospital, Strasbourg, France

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Valentina FAITOT, MD

CONTACT

03 88 12 70 75valentina.faitot@chru-strasbourg.fr

Gauthier VINEE, MD

CONTACT

03 88 12 70 75gauthieremmanuel.vinee@chru-strasbourg.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2018

First Posted

May 7, 2018

Study Start

March 13, 2018

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

June 4, 2018

Record last verified: 2018-03

Locations

FR(1)