(1) Main outcome: Comparison of performing and not performing the prophylactic surgery for urinary incontinence in advanced pelvic organ
(2) Design: Accidental
(3) Setting and conduct: 60 patients with advanced pelvic organ prolapse without a history of urinary incontinence, enrolled into the study. (Patients with advanced pelvic organ prolapse who suffer from urinary incontinence are excluded from the study.) Randomly 30 patients undergo urinary incontinence surgery in addition to prolapse surgery (TOT+ Standard surgery) and 30 patients undergo prolapse surgery without urinary incontinence surgery (Standard surgery) .Examination findings and ICIQ-SF questionnaire are recorded for all patients before surgery and 1 and 2 months after surgery. Patients will be followed up by phone or invitation to clinic for 2 months and asked if SUI is occurred.
(4) Participants including major eligibility criteria: Sample size is 60 patients. Inclusion criteria are women with advanced pelvic prolapse without urinary incontinence symptoms. Exclusion criteria are women with advanced vaginal prolapse with urinary incontinence symptoms.
(5) Intervention: Women with advanced pelvic organ prolapse without urinary incontinence undergo prophylactic surgery for urinary incontinence (TOT). Intervention is done concurrent with the standard surgery for advanced pelvic prolapse.
(6) Main outcome measures (variables): Development of SUI after surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013041513025N1
Registration date:2013-06-15, 1392/03/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-06-15, 1392/03/25
Registrant information
Name
Neda Shoari
Name of organization / entity
Tabriz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1336 6950
Email address
nedashoari@irimc.org
Recruitment status
Recruitment complete
Funding source
Women's reproductive health research center, Tabriz university of medical sciences.
Expected recruitment start date
2012-06-21, 1391/04/01
Expected recruitment end date
2013-06-22, 1392/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of performing and not performing the prophylactic surgery for urinary incontinence in advanced pelvic organ prolapse
Public title
Comparison of performing and not performing the prophylactic surgery for urinary incontinence in advanced pelvic organ prolapse
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Women with advanced vaginal prolapse without urinary incontinence symptoms.
Exclusion criteria: Women with advanced vaginal prolapse with urinary incontinence symptoms; Women who are not candidate for surgery due to comorbidities.(cardiac, pulmonary, etc)
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
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 Tabriz University of Medical Science
Street address
Research vice-chancellor, Central building number 2, Tabriz University of Medical Sciences, Golgasht street.
City
Tabriz
Postal code
Approval date
2013-03-13, 1391/12/23
Ethics committee reference number
5/4/12136
Health conditions studied
1
Description of health condition studied
Pelvic organ prolapse
ICD-10 code
N81
ICD-10 code description
Female genital prolapse
Primary outcomes
1
Description
Development of SUI after surgery
Timepoint
Before intervention, 1 month after intervention and 2 months after intervention.
Method of measurement
Standard questionnaire ICIQ-SF
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 30 patients undergo urinary incontinence surgery in addition to prolapse surgery (Standard surgery+ TOT).
Category
Treatment - Surgery
2
Description
Control group: 30 patients undergo urinary incontinence surgery without prolapse surgery (Standard surgery).
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Talegani educational and therapeutic center
Full name of responsible person
Neda Shoari
Street address
Talegani educational and therapeutic center, Rah-Ahan street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz university of medical sciences
Full name of responsible person
Dr Parvin Bastani
Street address
Daneshgah Ave, Tabriz university of medical sciences
City
Tabriz
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, Tabriz 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
Tabriz university of medical science
Full name of responsible person
Dr Parvin Bastani
Position
Assistant professor, Gynecologist, Orogynecology fellowship
Other areas of specialty/work
Street address
Talegani educational and therapeutic center, Rah-Ahan street
City
Tabriz
Postal code
Phone
+98 41 1443 5590
Fax
Email
bastanip@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz university of medical science
Full name of responsible person
Dr Parvin Bastani
Position
Assistant professor
Other areas of specialty/work
Street address
Talegani educational therapeutic center, Rah-Ahan street
City
Tabriz
Postal code
Phone
+98 41 1336 6950
Fax
Email
bastanip@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz university of medical science
Full name of responsible person
Dr Neda Shoari
Position
Resident of obstetrics and gynecology
Other areas of specialty/work
Street address
Alzahra educational and therapeutic center, Artesh steert
City
Tabriz
Postal code
Phone
+98 41 1336 6950
Fax
Email
nedashoari@irimc.org
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)