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

Genuine Stress Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03515109
• Other study ID #: 0001
• Status: Recruiting
• Phase: N/A
• Start date: November 25, 2017
• Est. completion date: November 25, 2018

Study information

• Verified date: April 2018
• Source: Aretaieio Hospital
• Contact: PANAGIOTIS VAKAS
• Phone: 2107473204
• Email: P_BAKAS[@]YAHOO.COM
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: November 25, 2018
• Est. primary completion date: March 25, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Genuine Stress Incontinence
• Urinary Incontinence, Stress

Intervention

Procedure:
• Altis tape
placement of Altis tape through transobturator foramen bilaterally under epidural anesthesia
• TVTO
placement of TVTO tape through transobturator foarmen bilaterally under epidural anesthesia

Locations

Country	Name	City	State
Greece	Aretaieio University Hospital	Athens	Attiki

Sponsors (1)

Lead Sponsor	Collaborator
Aretaieio Hospital

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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