Prospective Study of Altis System With the TVTO Procedure for the Management of Stress Urinary Incontinence in Women
Prospective Randomized Trial of Altis Minisling With the TVTO Transobturator Tape Procedure for the Management of Genuine Stress Urinaty Incontinence in Women
1 other identifier
interventional
40
1 country
1
Brief Summary
Prospective randomized comparison of minisling (altis) with the TVTO procedure for the management of women with genuine stress urinary incontinence.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 25, 2017
CompletedFirst Submitted
Initial submission to the registry
March 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 25, 2018
CompletedFirst Posted
Study publicly available on registry
May 3, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 25, 2018
CompletedMay 3, 2018
April 1, 2018
4 months
March 23, 2018
April 22, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the objective urinary continence rate at 12 months
Primary outcome measure will be the objective urinary continence rate at 12 months as it is assessed with cough stress test during urodynamics.
1 year
Secondary Outcomes (2)
Subjective urinary continence rate at 12 months follow up
1year
Preoperative and postoperative assessment of sexual function
1 year
Study Arms (2)
group A
ACTIVE COMPARATORAltis tape surgical placement
group B
PLACEBO COMPARATORTVT transobturator tape placement
Interventions
placement of Altis tape through transobturator foramen bilaterally under epidural anesthesia
placement of TVTO tape through transobturator foarmen bilaterally under epidural anesthesia
Eligibility Criteria
You may not qualify if:
- History of previous irradiation in the lower genital tract
- BMI more than 30kg/m2
- previous anti-incontinence surgery, previous vaginal surgery
- having MUCP\< 30 cm H2O or Valsava leak point pressure less than than 60 cm H2O
- Mixed urinary incontinence.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Aretaieio University Hospital
Athens, Attica, 11528, Greece
Related Publications (1)
Carter E, Johnson EE, Still M, Al-Assaf AS, Bryant A, Aluko P, Jeffery ST, Nambiar A. Single-incision sling operations for urinary incontinence in women. Cochrane Database Syst Rev. 2023 Oct 27;10(10):CD008709. doi: 10.1002/14651858.CD008709.pub4.
PMID: 37888839DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
PANAGIOTIS VAKAS
aretaieio university hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- they will not be aware of the procedure they are going to perform or have.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor Obstetrics and Gynecology
Study Record Dates
First Submitted
March 23, 2018
First Posted
May 3, 2018
Study Start
November 25, 2017
Primary Completion
March 25, 2018
Study Completion
November 25, 2018
Last Updated
May 3, 2018
Record last verified: 2018-04
Data Sharing
- IPD Sharing
- Will not share