Clinical trial NCT03515109: Prospective Study of Altis System With the TVTO Procedure for the Management of Stress Urinary Incontinence in Women
Official title: Prospective Randomized Trial of Altis Minisling With the TVTO Transobturator Tape Procedure for the Management of Genuine Stress Urinaty Incontinence in Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Genuine Stress Incontinence
Keywords: stress incontinence
female
altis
transobturator tape
minisling
Lead sponsor: Aretaieio Hospital
Sponsor class: OTHER
First posted: 2018-05-03
Enrollment: 40
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective randomised
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: the objective urinary continence rate at 12 months
timeFrame: 1 year
Secondary outcomes:
measure: Subjective urinary continence rate at 12 months follow up
timeFrame: 1year
measure: Preoperative and postoperative assessment of sexual function
timeFrame: 1 year
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Aretaieio University Hospital
state: Attiki
Study officials:
affiliation: aretaieio university hospital
name: PANAGIOTIS VAKAS
role: PRINCIPAL_INVESTIGATOR
References: