Objectives: Main goal of this study is evaluation of overactive bladder symptoms in women with pelvic organ prolapse before and after surgery in comparison with antimuscarinic drugs.
Setting and conduct: To evaluate the effect of obliterative or reconstructive surgery on recovery of overactive bladder. Before surgery, patients will be thorough history taking and pelvic examination will be complete. Before surgery, pelvic organ prolapse grade will be determined according to pelvic organ prolapse grading system. After collecting data, they will be entered in SPSS and will be analyzed.
Inclusion criteria:
All women with all grades of genital prolapse who can also respond to the questionnaire;
Women who will be undergoing obliterative or reconstructive surgery early;
Women who enrolled in the study from January 2013 to January 2014 and will be follow up for one year.
It will be available or convenient sampling method.
Exclusion criteria:
No satisfaction to enter the study will be the exclusion criteria.
Main outcome measures:
Frequent urination, Urinary urgency and Urge incontinence will be evaluated before the intervention and six months after the intervention. These symptoms will be assessed using selected questions from Pelvic Floor Distress Inventor (PFDI) valid questionnaire that is related to urinary distress.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016020626387N1
Registration date:2016-02-24, 1394/12/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-02-24, 1394/12/05
Registrant information
Name
Kima Rahmati
Name of organization / entity
Moheb Yas Women General Hospital, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 42046
Email address
farshadi@farabi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2013-01-20, 1391/11/01
Expected recruitment end date
2014-01-21, 1392/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Overactive bladder symptoms in women with pelvic organ prolapse before and after surgery
Public title
Overactive bladder symptoms in women with pelvic organ prolapse before and after surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All women with all grades of genital prolapse who can also respond to the questionnaire;
Women who will be undergoing obliterative or reconstructive surgery early;
Women who enrolled in the study from January 2013 to January 2014 and will be follow up for one year.
Exclusion criteria:
All patients who had incomplete information in their files; No satisfaction to enter the study.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
159
Randomization (investigator's opinion)
N/A
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 Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Qods St., Keshavarz Blvd., Tehran, Iran * آدرس Tehran
City
Tehran
Postal code
Approval date
2016-01-25, 1394/11/05
Ethics committee reference number
IR.TUMS.REC.139401744
Health conditions studied
1
Description of health condition studied
Overactive bladder
ICD-10 code
N32.8
ICD-10 code description
Other specified disorders of bladder
2
Description of health condition studied
Pelvic organ prolapse
ICD-10 code
N81.8
ICD-10 code description
Other female genital prolapse
Primary outcomes
1
Description
Frequent urination
Timepoint
At the beginning of the intervention, six months after the intervention, twelve months after the intervention