The necessity of urodynamic test in the patient with urine stress incontinency to identify patients and improve their quality of life after TOT (Transobturator) surgery.
OBJECTIVE: The necessity of urodynamic test in the patients with urine stress incontinency to identify the patients and improve their quality of life after TOT (Transobturator) surgery.Study design: A randomized clinical trial study.
Inclusion criteria: Women between 21 and 45 years old; stress urinary incontinency for 3 months; desire for surgery; negative urinalysis and urine culture.
Exclusion criteria: Urinary retention in absence of prolapse; previous pelvic surgery in the last 3 months; previous surgery for urinary incontinency; prolapse(grade 2); urination urgency; uncontrolled diabetes; urinary tract or bladder cancer; Pelvic Surgeries.
INTERVENTION:
48 women with urinary incontinency divided into two groups: 24 patients were randomly assigned to one of two groups.
Patients in the first group will be selected for trans-obturator surgery after Urodynamic test and patients in the second group will be selected based on the questionnaire for trans-obturator surgery After trans-obturator surgery in both groups, the results of the surgery and quality of life ( IQOL questionnaire) is going to be compared after 1 and 6 months after surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016060618655N3
Registration date:2017-04-05, 1396/01/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-04-05, 1396/01/16
Registrant information
Name
Tahereh Poordast
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3233 2365
Email address
poordast@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shiraz University of Medical Sciences
Expected recruitment start date
2016-06-09, 1395/03/20
Expected recruitment end date
2017-06-10, 1396/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The necessity of urodynamic test in the patient with urine stress incontinency to identify patients and improve their quality of life after TOT (Transobturator) surgery.
Public title
The necessity of urodynamic test in the patient with urine stress incontinency to identify patients and improve their quality of life after TOT (Transobturator) surgery.
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Between 21 -45 years old; having stress urinary incontinence for at least 3 months; urinalysis and urine culture tends to surgery.
Exclusion criteria:
Urinary retention by the absence of prolapse; a medical condition; previous pelvic surgery in the last 3 months; previous surgery for the treatment of urinary incontinence; grade 2 prolapse; patients with urgency urination; uncontrolled diabetes; urinary tract or bladder cancer treatment;
Pelvic Surgery
Age
From 21 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Vice Chancellor of research, Shiraz University of Medical Sciences, 7th floor, central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Postal code
Approval date
2016-04-25, 1395/02/06
Ethics committee reference number
IR.SUMS.REC.1395.4.145
Health conditions studied
1
Description of health condition studied
Urinary Stress Incontinancy
ICD-10 code
N39.3
ICD-10 code description
Stress incontinence
Primary outcomes
1
Description
The acquiesent ofTOT
Timepoint
Before TOTthen 1and6month after surgery
Method of measurement
IQOL questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Performing Urodynamic test.
Category
Diagnosis
2
Description
Fill out IQOL questionnaire
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Zeinab Hospital
Full name of responsible person
Name Naghizadeh
Street address
Defae Moghadas Square, Hazrat Zeinab Hospital
City
Shirsz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Shiraz University of Medical Sciences
Full name of responsible person
Dr Seed Basir Hashemi
Street address
Vice chancellor of research,7th floor of central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Najme Naghizadeh
Position
Gynecology Resident
Other areas of specialty/work
Street address
Gynecology Department, Faghihi Hospital, Zand Street
City
Shiraz
Postal code
Phone
+98 36474270
Fax
Email
Poordast@suma.sc.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz Universiy of Medical Sciences
Full name of responsible person
Tahereh Poordast
Position
Gynecologist
Other areas of specialty/work
Street address
Gynecology Department, Faghihi Hospital, Zand Street
City
Shiraz
Postal code
Phone
+98 71 3740 6274
Fax
Email
Poordast@yahoo
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Masihi
Position
MS in english teaching ,BS in anesthesia/English Consultant
Other areas of specialty/work
Street address
5th floor, Mohammad Rasul Allah Research Tower, Khalili Street
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
Poordast@yahoo
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)