Determining the effect of real acupressure on chronic urinary retention in patients with benign prostatic hypertrophy
Design
This study is a clinical trial with a control group (acupressure on sham points) and an intervention (acupressure on main points), with parallel groups, one blind strain (patient), randomized. 10 patients will be tested as a pilot, and then the second phase study will be done using the sample size formula.
Settings and conduct
This study is a double-blind randomized clinical trial (patient and analyst) that will be conducted on all patients with benign prostatic hypertrophy referred to the urology clinic of Mashhad University of Medical Sciences in 2014.
Before and after the intervention, information will be collected with a checklist containing demographic information and study variables.
Participants/Inclusion and exclusion criteria
inclusion criteria: Age over 45 years, diagnosis of Benign Prostatic Hyperplasia by a specialist doctor and confirmation of PVR above 100 ml with ultrasound and no coagulation disorders
Criteria for non-entry: the person's unwillingness to participate in the study, having cognitive problems and not being able to learn and perform acupressure, having a history of acute kidney problems and kidney stones
Intervention groups
Intervention group: Patients with benign prostatic hypertrophy who complain of urinary retention will be treated with acupressure.
Control group: will receive acupressure on negative sham-acupoints.
Main outcome variables
IPSS symptom score; the patient's urine output volume; dysuria; the remaining volume of urine after the end of the period; the average amount of urine excretion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220608055105N1
Registration date:2022-11-03, 1401/08/12
Registration timing:retrospective
Last update:2022-11-03, 1401/08/12
Update count:0
Registration date
2022-11-03, 1401/08/12
Registrant information
Name
Akram Kazem Karim Aljenahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 1511
Email address
aljenahia991@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-15, 1401/03/25
Expected recruitment end date
2022-07-06, 1401/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effects of acupressure on residual urine volume and dysuria in patients with benign prostatic hypertrophy
Public title
The effects of acupressure on the volume of urine and the intensity of micturition pain caused by prostate enlargement
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of Benign prostate hypertrophy by a specialist
Confirmation of the residual volume of the disease after evacuation of more than 100 cc with ultrasound
No coagulation disorders
Exclusion criteria:
The patient has undergone prostate surgery
The patient is not conscious or it is not possible to put pressure on the pressure points by him
Age
From 45 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible samples are first available and then randomly allocated in two intervention and control groups. In order to randomize, we use an opaque envelope that contains numbers equal to the number of the sample (from 1 to 20), in such a way that every patient who comes, we remove one number from the envelope. If the number is odd, the patient will be assigned to The intervention group is entered, and if it is even, it is entered into the control group, this process continues until reaching the desired sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
The only person who knows about the patient's treatment will be an acupressure specialist, and the researcher and sonographer will not know about the patient's treatment group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Doctor Crossroads - Ibn Sina St. School of Nursing and Midwifery - Postal Code: 9137913199
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2022-07-19, 1401/04/28
Ethics committee reference number
IR.MUMS.NURSE.REC.1401.061
Health conditions studied
1
Description of health condition studied
Benign prostatic hypertrophy
ICD-10 code
N40
ICD-10 code description
Enlarged prostate
Primary outcomes
1
Description
IPSS Symptom Score
Timepoint
6 sessions in 2 weeks
Method of measurement
Demographic information: Checklist containing patients' demographic information, IPSS symptom score (international prostate symptom score), volume of patient's voided urine: using a graduated container, starting time of voiding: by asking the patient, dysuria: by asking the patient, residual volume Urine before and 48 hours after the end of the course: with sonography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with benign prostatic hypertrophy who complain of urinary retention will be treated with acupressure on the affected points. The four main points in acupressure (Pang guanshu, Guan yuan, Shen men, San yinjiao) will be placed with the fingers for one minute and three kilograms of pressure. The length of treatment is 6 sessions in 2 weeks. The first point of acupressure group is BL 28 or Pang guanshu. This point is located at a distance of 1.5 as lateral to the posterior midline of the body at the level of the second hole of the sacrum or sacrum. The second point of acupressure group is CV4 or Guan yuan. This point is located on the middle line of the front of the body at a distance of 3 cm below the navel. The third point of acupressure group is HT7 or Shen men. This point is located on the lowest inner crease of the wrist, immediately after the tendon of the flexor carpi ulnaris muscle and on the radial side of the tendon. The fourth point of acupressure group is SP6 or San yinjiao. This point is located at a distance of 3, because it is above the most prominent part of the inner ankle of the foot and immediately behind the tibia bone.
Category
Treatment - Other
2
Description
Control group: patients with benign prostatic hypertrophy who complain of urinary retention and will be treated with sham or ineffective acupressure (Cheng Jian, Fei shu, Shao hai, Gong sun). Four ineffective points (sham) in acupressure will be placed with a finger for one minute each and a pressure of three kilograms. The length of the treatment is 6 sessions in 2 weeks. The first point of the acupressure group is Sham CV 24 or Cheng Jian. This point is located in the midline of the front of the body under the lower lip and in the mentolabial groove. The second point of the acupressure group is Sham BL 13 or Fei shu. This point is located on the back of the body and in alignment with the lower edge of the third thoracic vertebra and at a distance of 1.5 cm lateral to the midline of the back of the body. The third point of the Sham acupressure group is HT3 or Shao hai. This point is located in the inner part of the elbow bend between the inner end of the elbow crease and the inner epicondyle of the humerus. The fourth point of the Sham acupressure group is SP4 or Gong sun. This point is on the surface The inside of the foot is located on the border of the white and red skin of the sole and exactly in the middle of the foot arch.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Urology Center of Imam Reza Hospital
Full name of responsible person
Hamid Chamanzari
Street address
University St., Doctora Intersection, Ibn Sina St., School of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
+98 51 3859 7313
Email
aljenahia991@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayour-Mobarhan
Street address
Doctora Crossroad - Ibn Sina St. - School of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
ChamanzariH@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Research assistant of Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Hamid Chamanzari
Position
Graduate student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Doctora Crossroads - Ibn Sina St. - School of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
AljenahiA991@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamid Chamanzari
Position
Graduate student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Doctora Crossroads - Ibn Sina St. - School of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
AljenahiA991@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Akram Kazem Karim Aljenahi
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Urology
Street address
Chahar Rah Doktora- Ebn Sina- School of Nursing & Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
Email
AljenahiA991@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Research units participating in this study
Data include demographic characteristics, intervening variables, main variables (independent and dependent)
When the data will become available and for how long
From the beginning of July 2022 to December 2022
To whom data/document is available
Researcher, research assistant and statistics consultant
Under which criteria data/document could be used
The data is organized as an article and published in reputable journals
From where data/document is obtainable
Mr. Hamid Chamanzari/ Faculty of Nursing and Midwifery Mashhad/ ChamanzariH@mums.ac.ir/ 05138591511
What processes are involved for a request to access data/document
By obtaining permission from Mashhad University of Medical Sciences and then sending the application email along with the permission to the study researcher's email