Protocol summary

Study aim
Determination of urine volume for evaluation of urine voiding after anterior colporrhaphy surgery
Design
A phase I randomized, unblinded, two-intervention, parallel-group clinical trial on 110 patients, using sealed envelopes and a random number table for randomization.
Settings and conduct
In this clinical trial, 110 patients who were candidates for anterior colporrhaphy at Kowsar Women's Hospital in Urmia were randomly enrolled in the study and were divided into two groups without blinding to determine urine volume to evaluate bladder emptying after anterior colporrhaphy surgeries.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Pvr more than 150cc، patients with urinary tract damage that needs catheterization before surgery, detrusor muscle weakness at urodynamic test before surgery
Intervention groups
People who undergo anterior colporrhaphy fall into 2 groups: In group 1, the urinary catheter will be removed immediately after the surgery is completed and before the patient wakes up from anesthesia. Patients will be monitored for 6 hours and urinary function will be considered successful if they pass at least 150 ml of urine during the corresponding time.In group 2, patients will be discharged from the operating room with a urinary catheter, and the bladder will be filled with 300 ml of normal saline after the patients wake up from anesthesia, and then the urinary catheter will be removed. Patients should then be monitored for urinary function over a period of sixty minutes.
Main outcome variables
Age, BMI, parity, previous surgical history, preoperative PVR, postoperative PVR, surgical duration, urinary function success, urine output, full and empty bladder volume, postoperative urinary retention, length of stay, complications, need for catheterization after surgery

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250621066214N1
Registration date: 2025-07-12, 1404/04/21
Registration timing: prospective

Last update: 2025-07-12, 1404/04/21
Update count: 0
Registration date
2025-07-12, 1404/04/21
Registrant information
Name
elham rajabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3346 0998
Email address
rajabi.e@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-07-21, 1404/04/30
Expected recruitment end date
2026-06-30, 1405/04/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the success rate in urinary evacuation after women's anterior colporrhaphy surgeries using two methods: spontaneous urinary evacuation and retrograde bladder filling.
Public title
Comparison of the success rate in urinary evacuation after women's anterior colporrhaphy surgeries using two methods: spontaneous urinary evacuation and retrograde bladder filling.
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Patients candidates for anterior colporrhaphy for pelvic organ prolapse surgeries or urinary incontinence. Age over 18 years Satisfaction regarding participation in the study
Exclusion criteria:
Patients who require catheterization before surgery due to urinary system damage. PVR above 150 milliliters Hypofunction of the detrusor muscle in preoperative urodynamic studies.
Age
From 18 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 110
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was done simply and individually by selecting from a sealed envelope.
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 urmia University of Medical Sciences
Street address
Resalat ave
City
Urmia
Province
West Azarbaijan
Postal code
5715755787
Approval date
2025-05-27, 1404/03/06
Ethics committee reference number
IR.UMSU.REC.1404.051

Health conditions studied

1

Description of health condition studied
Cystocele
ICD-10 code
N81.11
ICD-10 code description
Cystocele, midline

Primary outcomes

1

Description
Rate of success in emptying urine after anterior Colporrhaphy
Timepoint
Three hours after surgery and four days after discharge
Method of measurement
Nelaton catheter and measuring cup

Secondary outcomes

1

Description
Rate of urine infection after surgery
Timepoint
30 day after surgery
Method of measurement
Urin analysis and patient symptoms

Intervention groups

1

Description
Intervention group1: Backfilling the bladder with 300 cc of normal saline, then removing the Foley catheter and allowing the patient to void urine for one hour and checking the amount of urine excreted.
Category
N/A

2

Description
Intervention group2: Removing the Foley catheter without filling the bladder with normal saline and allowing the patient to void within 6 hours
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Kosar Hospital Urmia
Full name of responsible person
Doctor Elham Rajabi
Street address
Hasani Ave
City
Urmia
Province
West Azarbaijan
Postal code
5715859497
Phone
+98 914 330 4699
Email
Dr.elhamrajabi27@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr Saber GHolizade
Street address
Resalat Ave
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 1930
Email
research@umsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Dr.Negar Alizade
Position
Obstetrics and Gynecology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Bargh Ave
City
Urmia
Province
West Azarbaijan
Postal code
5715781367
Phone
+98 914 603 6726
Email
Dr.negaralizade@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr.Negar Alizade
Position
Obstetrics and Gynecology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Bargh Ave
City
Urmia
Province
West Azarbaijan
Postal code
5715781367
Phone
+98 914 603 6726
Email
Dr.negaralizade@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr.Negar Alizade
Position
Obstetrics and Gynecology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Bargh Ave
City
Urmia
Province
West Azarbaijan
Postal code
5715781367
Phone
+98 914 603 6726
Email
Dr.negaralizade@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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