Genuine Stress Incontinence
Conditions
Keywords
stress incontinence, female, altis, transobturator tape, minisling
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.
Interventions
PROCEDUREAltis tape
placement of Altis tape through transobturator foramen bilaterally under epidural anesthesia
PROCEDURETVTO
placement of TVTO tape through transobturator foarmen bilaterally under epidural anesthesia
Sponsors
Aretaieio Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
they will not be aware of the procedure they are going to perform or have.
Intervention model description
prospective randomised
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 80 Years
Healthy volunteers
Yes
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Greece
Contacts
Primary ContactPANAGIOTIS VAKAS
Backup ContactEmmanouil papadakis, Dr
Outcome results
None listed