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

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ClinicalTrials.gov Identifier: NCT03515109
Recruitment Status : Recruiting
First Posted : May 3, 2018
Last Update Posted : May 3, 2018
Sponsor:
Information provided by (Responsible Party):
PANAGIOTIS BAKAS MD, Aretaieio Hospital

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 Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: prospective 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 : November 25, 2017
Actual Primary Completion Date : March 25, 2018
Estimated Study Completion Date : November 25, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. the objective urinary continence rate at 12 months [ Time Frame: 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 :
  1. Subjective urinary continence rate at 12 months follow up [ Time Frame: 1year ]
    Secondary outcome measure will be the subjective continence rate as it is assessed with the use of the PGI-I questionnaire.

  2. Preoperative and postoperative assessment of sexual function [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03515109


Contacts
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Contact: PANAGIOTIS VAKAS 2107473204 P_BAKAS@YAHOO.COM
Contact: Emmanouil papadakis, Dr 6944864531 papadakisemm2@gmail.com

Locations
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Greece
Aretaieio University Hospital Recruiting
Athens, Attiki, Greece, 11528
Contact: PANAGIOTIS VAKAS    2107473204    P_BAKAS@YAHOO.COM   
Sponsors and Collaborators
Aretaieio Hospital
Investigators
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Principal Investigator: PANAGIOTIS VAKAS aretaieio university hospital

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Responsible Party: PANAGIOTIS BAKAS MD, Associate Professor Obstetrics and Gynecology, Aretaieio Hospital
ClinicalTrials.gov Identifier: NCT03515109     History of Changes
Other Study ID Numbers: 0001
First Posted: May 3, 2018    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by PANAGIOTIS BAKAS MD, Aretaieio Hospital:
stress incontinence
female
altis
transobturator tape
minisling
Additional relevant MeSH terms:
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Urinary Incontinence, Stress
Urinary Incontinence
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms