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

Sponsor

Aretaieio Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03515109

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Genuine Stress Incontinence	Procedure: Altis tape Procedure: TVTO	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

prospective randomisedprospective randomised

Masking:

Double (Participant, Investigator)

Masking Description:

they will not be aware of the procedure they are going to perform or have.

Primary Purpose:

Treatment

Official Title:

Prospective Randomized Trial of Altis Minisling With the TVTO Transobturator Tape Procedure for the Management of Genuine Stress Urinaty Incontinence in Women

Actual Study Start Date :

Nov 25, 2017

Actual Primary Completion Date :

Mar 25, 2018

Anticipated Study Completion Date :

Nov 25, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: group A Altis tape surgical placement	Procedure: Altis tape placement of Altis tape through transobturator foramen bilaterally under epidural anesthesia
Placebo Comparator: group B TVT transobturator tape placement	Procedure: TVTO placement of TVTO tape through transobturator foarmen bilaterally under epidural anesthesia

Arm

Intervention/Treatment

Active Comparator: group A

Altis tape surgical placement

Procedure: Altis tape

placement of Altis tape through transobturator foramen bilaterally under epidural anesthesia

Placebo Comparator: group B

TVT transobturator tape placement

Procedure: TVTO

placement of TVTO tape through transobturator foarmen bilaterally under epidural anesthesia

Outcome Measures

Primary Outcome Measures

the objective urinary continence rate at 12 months [1 year]
Primary outcome measure will be the objective urinary continence rate at 12 months as it is assessed with cough stress test during urodynamics.

Secondary Outcome Measures

Subjective urinary continence rate at 12 months follow up [1year]
Secondary outcome measure will be the subjective continence rate as it is assessed with the use of the PGI-I questionnaire.
Preoperative and postoperative assessment of sexual function [1 year]
Patients will be asked to complete preoperatively and postoperatively the female sexual function index. Minimum score 2.0 and maximum score 36.0. Higher values represent a better outcome.

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 80 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aretaieio University Hospital	Athens	Attiki	Greece	11528

Sponsors and Collaborators

Aretaieio Hospital

Investigators

Principal Investigator: PANAGIOTIS VAKAS, aretaieio university hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

PANAGIOTIS BAKAS MD, Associate Professor Obstetrics and Gynecology, Aretaieio Hospital

ClinicalTrials.gov Identifier:

NCT03515109

Other Study ID Numbers:

0001

First Posted:

May 3, 2018

Last Update Posted:

May 3, 2018

Last Verified:

Apr 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by PANAGIOTIS BAKAS MD, Associate Professor Obstetrics and Gynecology, Aretaieio Hospital

Additional relevant MeSH terms:

Urinary Incontinence, Stress

Study Results

No Results Posted as of May 3, 2018