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

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

Study Overview

• Status: Unknown
• Conditions: Genuine Stress Incontinence
• Intervention / Treatment: Procedure: Altis tape; Procedure: TVTO

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: PANAGIOTIS VAKAS; Phone Number: 2107473204; Email: P_BAKAS@YAHOO.COM
• Study Contact Backup: Name: Emmanouil papadakis, Dr; Phone Number: 6944864531; Email: papadakisemm2@gmail.com

Study Locations

• Greece
  • Attiki
    • Athens, Attiki, Greece, 11528
      • Recruiting
      • Aretaieio University Hospital
      • Contact: PANAGIOTIS VAKAS; Phone Number: 2107473204; Email: P_BAKAS@YAHOO.COM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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	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.	1 year

Collaborators and Investigators

• Sponsor: Aretaieio Hospital
• Investigators: Principal Investigator: PANAGIOTIS VAKAS, Aretaieio University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2017
• Primary Completion (Actual): March 25, 2018
• Study Completion (Anticipated): November 25, 2018

Study Registration Dates

• First Submitted: March 23, 2018
• First Submitted That Met QC Criteria: April 22, 2018
• First Posted (Actual): May 3, 2018

Study Record Updates

• Last Update Posted (Actual): May 3, 2018
• Last Update Submitted That Met QC Criteria: April 22, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: female; stress incontinence; altis; transobturator tape; minisling
• Additional Relevant MeSH Terms: Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Urinary Incontinence; Urinary Incontinence, Stress
• Other Study ID Numbers: 0001 (Cancer Research Institute)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes