Comparison of the Effectiveness of Bladder Training and Pelvic Floor Muscle Exercises (Kegel Exercises) with Usual Care on Urinary Incontinence and Quality of Life in Men Candidates for Transurethral Resection of the Prostate (TURP)
To compare the effects of bladder training and Kegel exercises on urinary incontinence and quality of life in men undergoing transurethral resection of the prostate.
Design
This is an open label, randomized, three arm parallel clinical trial on 90 participants. Simple individual randomization by drawing numbered lots without replacement will allocate 30 participants to each group. Trial phase is not applicable.
Settings and conduct
The study will be conducted at the Urology Clinic of Shahid Beheshti Educational Hospital in Hamadan. After eligibility assessment and written informed consent, participants will be randomly allocated to the three groups. No blinding will be performed.
Participants/Inclusion and exclusion criteria
Men aged 40 to 80 years who are candidates for transurethral resection of the prostate, have at least primary school education, and are willing to participate will be included; those with previous pelvic surgery, cognitive impairment, prior bladder or Kegel training, or urinary incontinence due to diabetes or urinary tract infection will not be included.
Intervention groups
The bladder training group will receive usual care plus scheduled voiding, urgency control techniques, restriction of bladder irritant fluids, and urinary pattern recording. The Kegel group will receive usual care plus 40 pelvic floor muscle exercises daily. Both interventions will start one week before surgery and continue for eight weeks after surgery. The control group will receive usual care only.
Main outcome variables
Urinary incontinence severity; quality of life related to urinary symptoms.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20260915071067N1
Registration date:2026-09-16, 1405/06/25
Registration timing:prospective
Last update:2026-09-16, 1405/06/25
Update count:0
Registration date
2026-09-16, 1405/06/25
Registrant information
Name
Seyed Ali Rasooli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3323 9840
Email address
sa.rasooli@umsha.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-10-07, 1405/07/15
Expected recruitment end date
2027-04-04, 1406/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Bladder Training and Pelvic Floor Muscle Exercises (Kegel Exercises) with Usual Care on Urinary Incontinence and Quality of Life in Men Candidates for Transurethral Resection of the Prostate (TURP)
Public title
Effect of Bladder Training and Kegel Exercises on Urinary Incontinence and Quality of Life After Transurethral Resection of the Prostate
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Men who are candidates for Transurethral Resection of the Prostate (TURP).
Patients undergoing TURP surgery according to the urologist's decision.
Age between 40 and 80 years.
Having primary school education or higher.
Willingness to participate in the study and signing the informed consent form.
No history of previous pelvic surgery.
No diagnosis of prostate cancer based on postoperative pathology results.
No previous training in bladder training or Kegel exercises before entering the study.
No cognitive impairment.
No urinary incontinence caused by underlying diseases such as diabetes or urinary tract infections.
Exclusion criteria:
Diagnosis of prostate cancer based on pathology results
History of previous pelvic surgery
Previous training in bladder training or Kegel exercises
Presence of cognitive impairment
Presence of urinary incontinence caused by conditions such as diabetes or urinary tract infection
Age
From 40 years old to 80 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization in this study will be performed using simple randomization at the individual level. After selecting eligible participants and obtaining written informed consent, each participant will be assigned a number from 1 to 90. The assigned numbers will be placed in a bag, and participants will be randomly allocated without replacement into three groups of 30 participants: the bladder training group, the Kegel exercise group, and the control group. Stratified or cluster randomization will not be used in this study. The random sequence will be generated by a random drawing method. For allocation concealment, the assigned numbers will be kept in the bag until the final allocation, and each participant's group assignment will be determined only after confirmed enrollment in the study.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This study is a randomized clinical trial with a parallel three-group design. After confirming eligibility criteria and obtaining informed consent, participants will be randomly allocated into three groups: bladder training group, Kegel exercise group, and control group. The interventions will start one week before Transurethral Resection of the Prostate (TURP) surgery and will continue for eight weeks after surgery. The primary outcomes, including urinary incontinence and quality of life related to urinary problems, will be assessed before the intervention and after completion of the intervention period.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Central Office of Hamadan University of Medical Sciences, Shahid Fahmideh Boulevard, Pajouhesh Square, Hamadan
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Approval date
2026-09-12, 1405/06/21
Ethics committee reference number
IR.UMSHA.REC.1405.469
Health conditions studied
1
Description of health condition studied
Benign Prostatic Hyperplasia
ICD-10 code
N40
ICD-10 code description
Benign prostatic hyperplasia
Primary outcomes
1
Description
Urinary incontinence severity
Timepoint
Measurement of urinary incontinence severity before the intervention and two months after transurethral resection of the prostate
Method of measurement
International Consultation on Incontinence Questionnaire short form
2
Description
Quality of life related to urinary symptoms
Timepoint
Measurement of quality of life related to urinary symptoms before the intervention and two months after transurethral resection of the prostate
Method of measurement
Lower urinary tract symptoms quality of life questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Participants in this group will receive bladder training in addition to usual care. Bladder training includes scheduled voiding, urgency control techniques, limitation of bladder irritant fluid intake, and recording urinary patterns. This intervention will start one week before transurethral resection of the prostate and will continue for eight weeks after surgery.
Category
Rehabilitation
2
Description
Intervention group 2: Participants in this group will receive pelvic floor muscle exercises (Kegel exercises) in addition to usual care. The intervention includes contraction and relaxation of pelvic floor muscles performed 40 times daily. Patients will receive instructions on correct performance of the exercises. The intervention will start one week before transurethral resection of the prostate and will continue for eight weeks after surgery.
Category
Rehabilitation
3
Description
Control group: Participants in this group will receive routine care and education before and after transurethral resection of the prostate. This group will not receive any specific training in bladder training or pelvic floor muscle exercises.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Urology Clinic of Shahid Beheshti Educational Hospital, Hamadan
Full name of responsible person
Seyed Ali Rasooli
Street address
Shahid Beheshti Specialized and Subspecialized Educational and Treatment Center, Eram Boulevard Beginning, Ghaem Square
City
Hamadan
Province
Hamadan
Postal code
5235487456
Phone
+98 81 3838 0704
Email
shahidbeheshti@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Alireza Soltanian
Street address
Central Office of Hamadan University of Medical Sciences, Shahid Fahmideh Boulevard, Pajouhesh Square, Hamadan
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 81 3131 0000
Email
webda@umsha.ac.ir
Grant name
Not applicable
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Seyed Ali Rasooli
Position
Faculty Member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Central Office of Hamadan University of Medical Sciences, Shahid Fahmideh Boulevard, Pajouhesh Square, Hamadan
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 81 3323 9840
Email
alirasoolix6@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Seyed Ali Rasooli
Position
Faculty Member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Central Office of Hamadan University of Medical Sciences, Shahid Fahmideh Boulevard, Pajouhesh Square, Hamadan
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 81 3323 9840
Email
alirasoolix6@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Seyed Ali Rasooli
Position
Faculty Member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Central Office of Hamadan University of Medical Sciences, Shahid Fahmideh Boulevard, Pajouhesh Square, Hamadan
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 81 3323 9840
Email
alirasoolix6@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
Due to maintaining participants' confidentiality and adhering to research ethics principles, individual participant data will not be publicly shared.
Study Protocol
Yes - There is 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
Title and more details about the data/document
Final study report including study methods, data analysis, and overall results after completion of the study and publication of findings.
When the data will become available and for how long
After completion of the study and publication of the research findings.
To whom data/document is available
Researchers and eligible individuals whose requests for scientific use of the study documents are reviewed and approved.
Under which criteria data/document could be used
The documents may only be used for scientific and research purposes while maintaining confidentiality and research ethics principles.
From where data/document is obtainable
Requests should be submitted through correspondence with the principal investigator or Hamadan University of Medical Sciences.
What processes are involved for a request to access data/document
Requests will be reviewed, and access will be provided when possible after approval of the scientific purpose and compliance with ethical requirements.