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Comparison of incidence of painful bladder spasm between Pezzer catheter and 3-way Foley catheter used for suprapubic catheterization after open simple prostatectomy

Protocol summary

Study aim
Comparison the effect of three-way Pezzer and Foley catheters used for suprapubic catheterization in patients with open prostatectomy for painful bladder spasms
Design
This study is designed as a clinical trial with a randomized controlled group that will be performed as a single blind and single center with a sample size of 159. Sampling method and selection of samples for inclusion in the study will be non-randomly available and sequentially open among patients candidates for prostatectomy.
Settings and conduct
At Amir Al-Momenin Hospital in Tehran, after obtaining informed consent from patients undergoing open prostatectomy about the study, the urological surgeon used one of two types of Pezzer or Foley catheter for suprapubic catheterization and the patient is evaluated for postoperative bladder spasms by questionnaire.
Participants/Inclusion and exclusion criteria
Entry conditions: Patients with a diagnosis of LUTS / BPH who have undergone simple open prostatectomy as indicated. No-entry conditions: Atonic bladder, history of pelvic surgery (prostate or urinary tract), non-BPH-related disorders, history of coagulation disorder, history of opioid use
Intervention groups
According to the mentioned indications, after obtaining the consent of the research, patients are divided into two groups A and B, and in group A, a Pezzer suprapubic catheter is placed, and in group B, a three-way Foley catheter is placed as a suprapubic catheter. After surgery, patients are evaluated for the frequency and severity of painful bladder spasms by the researcher through a questionnaire and data are collected.
Main outcome variables
Determining the relationship between the severity and frequency of painful bladder spasms and the type of suprapubic catheter used after surgery.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220121053778N1
Registration date: 2022-06-06, 1401/03/16
Registration timing: retrospective

Last update: 2022-06-06, 1401/03/16
Update count: 0
Registration date
2022-06-06, 1401/03/16
Registrant information
Name
Mojtaba Farahani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5595 3612
Email address
everlasting@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-22, 1400/03/01
Expected recruitment end date
2022-05-22, 1401/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of incidence of painful bladder spasm between Pezzer catheter and 3-way Foley catheter used for suprapubic catheterization after open simple prostatectomy
Public title
The effect of suprapubic catheters on painful bladder spasms
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with severe complications from enlarged prostate including: refractory urinary retention, persistent gross hematuria, bladder stones, recurrent UTI, evidence of upper or lower urinary tract dysfunction (such as azotemia / uremia), and urinary incontinence Overflow / urge type and prostate weighing more than 65-70 grams (estimated by DRE examination and ultrasound) are candidates for open prostatectomy and inclusion in the study. Patients with suspected prostate cancer (with increased PSA or abnormal DRE) can be candidates for open prostatectomy if the prostate biopsy test is negative.
Exclusion criteria:
Atonic bladder (confirmed by urodynamic study) Urinary disorders not related to BPH such as neurogenic bladder disorder History of pelvic surgery, including previous prostate or urethral surgery History of coagulation disorders Chronic pain condition History of opioid use
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 159
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
In the implementation of this clinical trial intervention, which is a single blind study, participants (patients) are selected based on the inclusion criteria. After obtaining informed consent to conduct research in the intervention groups, they are classified and kept blind.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics in research committee of Tehran Azad University of Medical Sciences
Street address
No. 50, Riazatkesh Alley, Deylaman jonoubi St, Rey, Tehran
City
ری
Province
Tehran
Postal code
1848834661
Approval date
2021-02-21, 1399/12/03
Ethics committee reference number
IR.IAU.TMU.REC.1399.508

Health conditions studied

1

Description of health condition studied
Benign Prostatic Hyperplasia
ICD-10 code
N40.1
ICD-10 code description
Enlarged prostate with lower urinary tract symptoms

2

Description of health condition studied
Painful Bladder Spasms
ICD-10 code
N39.82
ICD-10 code description
Other specified disorders of bladder

3

Description of health condition studied
Prostate cancer
ICD-10 code
C61
ICD-10 code description
Malignant neoplasm of prostate

Primary outcomes

1

Description
Bladder Pain Score
Timepoint
Measurement of bladder pain score after surgery during the patient's hospitalization
Method of measurement
Bladder spasm symptom scale

2

Description
Bladder Pain Score
Timepoint
Measurement of bladder pain score after surgery during the patient's hospitalization
Method of measurement
Visual Analogue Scale

Secondary outcomes

1

Description
Painkiller dosage
Timepoint
During Post operation hospitalization
Method of measurement
According to the documented prescription

Intervention groups

1

Description
Intervention group: a
Category
Treatment - Devices

2

Description
Intervention group: b
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Amiralmomenin Hospital
Full name of responsible person
Mojtaba Farahani
Street address
No.50, Riazatkesh Alley, Deylaman Jonoubi St, Rey
City
Rey
Province
Tehran
Postal code
1848834661
Phone
+98 21 5595 3612
Email
everlastingfrni@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Mehrdad Gholamzad
Street address
No. 50, Riazatkesh Alley, Deylaman Jonoubi St, Rey
City
Rey
Province
Tehran
Postal code
1848834661
Phone
+98 21 5595 3612
Email
everlastingfrni@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Mojtaba Farahani
Position
Intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No. 50, Riazatkesh Alley, Deylaman jonoubi St, Imam Hossein St, Rey, Tehran
City
Tehran
Province
Tehran
Postal code
1848834661
Phone
+98 21 5595 3612
Fax
Email
everlasting@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mojtaba Farahani
Position
Intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No. 50, Riazatkesh Alley, Deylaman jonoubi St, Imam Hossein St, Rey, Tehran
City
Tehran
Province
Tehran
Postal code
1848834661
Phone
+98 21 5595 3612
Fax
Email
everlasting@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mojtaba Farahani
Position
Intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No. 50, Riazatkesh Alley, Deylaman jonoubi St, Imam Hossein St, Rey, Tehran
City
Tehran
Province
Tehran
Postal code
1848834661
Phone
+98 21 5595 3612
Fax
Email
everlasting@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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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