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
Prospective randomized comparison of minisling (altis) with the TVTO procedure for the management of women with genuine stress urinary incontinence.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05225168 -
Comparison of Minisling Suburethral Sling and Laparoscopic Buch Colposuspension
|
N/A |