Midralethral sling combination and low dose dysport injection compared to sling alone in combined urinary incontinence
Design
In this double-blind, randomized clinical controlled trial, 10 patients were randomly selected as the intervention group based on computerized blocking system and underwent sling surgery with simultaneous injection of 500 units of dysport, and 10 patients as control group underwent sling surgery alone.
Settings and conduct
Patients will be evaluated and evaluated for response to treatment at 1 month and 3 months after surgery. The treatment evaluation in this study will be based on ICIQ and ICIQ-OAB questionnaires.
This study uses blinding techniques to prevent bias as much as possible. This is because the surgeon is not aware of the patient's name and the person responsible for completing the questionnaire will be unaware of which patient is in which group.
Participants/Inclusion and exclusion criteria
In this study, 20 patients with combined urinary incontinence who did not respond to drug therapy will be enrolled. Everyone will be examined and given a history. Patients with hypertrophic urethra, severe prolapse, neurogenic disease (MS, CVA, etc.) and patients with a history of abdominal surgery are excluded. The rest will be urodynamic and patients with VLPP + + D.O, Cough induced D.O + leakage, and Capacity normal or average will be included in the study.
Intervention groups
In this study, 10 patients underwent TOT surgery with 500 Dysport injections and the rest of the patients will undergo TOT surgery alone.
Main outcome variables
Comparison of response rate to treatment of urinary incontinence in two methods
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130306012728N7
Registration date:2020-03-01, 1398/12/11
Registration timing:registered_while_recruiting
Last update:2020-03-01, 1398/12/11
Update count:0
Registration date
2020-03-01, 1398/12/11
Registrant information
Name
Sakineh Hajebrahimi
Name of organization / entity
Urology Department, Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7328
Email address
ebrahimis@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2020-06-21, 1399/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Combination of midurethral sling vs low-dose dysport injection in comparison with midurethral sling alone in mixed incontinence
Public title
effect of dysport in addition to surgery of incontinence
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
mixed urinary incontinence with no response to drugs
Patients with VLPP+ + D.O،Cough induced D.O + Leakage و Capacity normal or average in urodynamic study