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Evaluation of bladder function in patients with overactive bladder after cystocele repair

Protocol summary

Study aim
Determination of bladder function in women with overactive bladder after cystocele repair
Design
A single arm clinical trial, on 50 patients
Settings and conduct
In this study, 50 patients with the overactive bladder are included in the study. Due to having only one treatment group, there is no blinding. These patients undergo cystocele repair. Before, one and six months after the intervention, bladder function is evaluated and recorded.
Participants/Inclusion and exclusion criteria
Inclusion criteria include age 18 years and older, diagnosis of overactive bladder, frequent urination more than eight times a day, feeling of urinary urgency more than once a day, being married, and satisfaction to participate in the study. Exclusion criteria include breastfeeding, pregnancy, use of contraceptive methods, anticholinergic contraindication, need for a catheter, obstruction of the bladder outlet, and history of genitourinary surgery.
Intervention groups
In this study, patients with overactive bladder underwent cystocele repair. Before, one and six months after the intervention, bladder function is checked.
Main outcome variables
Urine urgency; Frequent urination; Urgent incontinence; Genital pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201108049307N1
Registration date: 2020-12-18, 1399/09/28
Registration timing: registered_while_recruiting

Last update: 2020-12-18, 1399/09/28
Update count: 0
Registration date
2020-12-18, 1399/09/28
Registrant information
Name
Shekoofeh Gholipour nouroozi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5264 0795
Email address
behnammokhtari630@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-22, 1399/08/01
Expected recruitment end date
2021-06-20, 1400/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of bladder function in patients with overactive bladder after cystocele repair
Public title
Bladder function in patients with overactive bladder after cystocele repair
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 years and older Diagnosis of overactive bladder Frequent urination more than eight times a day Feeling of urinary urgency more than once a day Being married Satisfaction to participate in the study
Exclusion criteria:
Breastfeeding Pregnancy Use of contraceptive methods Anticholinergic contraindication Need for catheter Obstruction of bladder outlet History of genitourinary surgery
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq.
City
Isfahan
Province
Isfehan
Postal code
8179964167
Approval date
2020-10-07, 1399/07/16
Ethics committee reference number
IR.MUI.MED.REC.1399.581

Health conditions studied

1

Description of health condition studied
Overactive bladder
ICD-10 code
N32.81
ICD-10 code description
Overactive bladder

Primary outcomes

1

Description
Urine urgency
Timepoint
Before, 1 month and 6 months after the intervention
Method of measurement
Visual Analogue Scale

2

Description
Frequent urination
Timepoint
Before, 1 month and 6 months after the intervention
Method of measurement
Visual Analogue Scale

3

Description
Urgent incontinence
Timepoint
Before, 1 month and 6 months after the intervention
Method of measurement
Visual Analogue Scale

4

Description
Genital pain
Timepoint
Before, 1 month and 6 months after the intervention
Method of measurement
Visual Analogue Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In this group, patients with overactive bladder underwent cystocele repair. Before, one and six months after the intervention, bladder function is checked.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti Hospital of Isfahan
Full name of responsible person
Maryam Hajhashemi
Street address
Department of Obstetrics and Gynecology, Shahid Beheshti Hospital, Motahhari Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3234 6338
Email
m_hajihashemy@med.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo Javanmard
Street address
Vice Chancellor for Research, School of Medicine, Hezar Jarib Street, Isfahan.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8597
Email
dean@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shekofeh Gholi Pour
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Department of Obstetrics and Gynecology, Shahid Beheshti Hospital, Motahhari Street
City
Hsfahan
Province
Isfehan
Postal code
8491875893
Phone
+98 31 3234 6338
Email
Behnammokhtari630@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Hajhashemi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Department of Obstetrics and Gynecology, Shahid Beheshti Hospital, Motahhari Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3234 6338
Email
m_hajihashemy@med.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shekoofeh Gholi pour
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Department of Obstetrics and Gynecology, Shahid Beheshti Hospital, Motahhari Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3234 6338
Email
Behnammokhtari630@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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