Prospective Study of Altis System With the TVTO Procedure... | NCT03515109

Studies
Prospective Study of Altis System With the TVTO Procedure for the Management of Stress Urinary Incontinence in Women

NCT03515109

Sponsor

Aretaieio Hospital

Status

Unknown status

Last Update Posted

May 3, 2018Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Genuine Stress Incontinence

Interventions

Altis tape
TVTO

Countries

Greece

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 25, 2017Actual

Primary Completion Date

Mar 25, 2018Actual

Completion Date

Nov 25, 2018Estimated

First Submitted Date

Mar 23, 2018

First Submission Date that Met QC Criteria

Apr 22, 2018

First Posted Date

May 3, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 22, 2018

Last Update Posted Date

May 3, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

PANAGIOTIS BAKAS MD, Associate Professor Obstetrics and Gynecology, Aretaieio HospitalPrincipal Investigator

Lead Sponsor

Aretaieio HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Prospective randomized comparison of minisling (altis) with the TVTO procedure for the management of women with genuine stress urinary incontinence.

Detailed Description

Prospective randomized study double blinded. Two group of patients consisting group A of 40 patients being operated with altis minisling and group B with 40 patients operated with TVTO procedure. All patients will be operated with epidural anesthesia.

The patients participating in the study will meet the following requirements. a. Having genuine stress urinary incontinence proven by urodynamics, b. be willing to be operated and participate in the study. Exclusion criteria wil be the following: a.History of previous irradiation in the lower genital tract, b. BMI more than 30kg/m2, c.previous anti-incontinence surgery, previous vaginal surgery, e. having MUCP< 20 cm H2O or Valsava leak point pressure less than than 60 cm H2O.

Patients will be allocated in each operation by an automatic system using a computer software.

Primary outcome measure will be the objective cure rate at 6 months as it is assessed with cough stress test during urodynamics. Secondary outcome measures will be the subjective cure rate, improvement and failure rate, the incidence of complications such as obstruction, voiding difficulties, hemorrhage etc. Patients will be asked to complete preoperatively and postoperatively the ICIQ-FLUTS, patient satisfaction questionnaire and the female sexual function index.postoperatively the patients will complete the PGI-I questionnaire.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
group A	Active Comparator	Altis tape surgical placement	Procedure: Altis tape
group B	Placebo Comparator	TVT transobturator tape placement	Procedure: TVTO

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Altis tape	Procedure	placement of Altis tape through transobturator foramen bilaterally under epidural anesthesia	group A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Subjective urinary continence rate at 12 months follow up	Secondary outcome measure will be the subjective continence rate as it is assessed with the use of the PGI-I questionnaire.	1year
Preoperative and postoperative assessment of sexual function

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusin Criteria:

Having genuine stress urinary incontinence proven by urodynamics
be willing to be operated and participate in the study.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
PANAGIOTIS VAKAS	Contact	2107473204		P_BAKAS@YAHOO.COM
Emmanouil papadakis, Dr	Contact	6944864531		papadakisemm2@gmail.com

Overall Officials

Name	Affiliation	Role
PANAGIOTIS VAKAS	aretaieio university hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aretaieio University Hospital	Recruiting	Athens	Attica	11528	Greece

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37888839	Derived	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.

ID	Term
D014549	Urinary Incontinence
D014555	Urination Disorders
D014570	Urologic Diseases
D052776	Female Urogenital Diseases