Benign Prostatic HyperplasiaNCT06051383
Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia
A study testing Self management in people with Benign Prostatic Hyperplasia, run by Amna A. Desouky, MD at 1 site in Egypt.
Trial summary
Aim of this study is to evaluate the effect of conducting self-management interventions on severity of lower urinary tract symptoms (LUTS) for patients with benign prostatic hyperplasia (BPH). Read more about this study
- Who is it for?
- Ages 40 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Self management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2023to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients.
- Men.
- Clinical diagnosis of benign prostatic hyperplasia.
Who cannot join
- Prostate cancer.
- Severe symptoms necessitating surgical treatment.
- Uncontrolled diabetes.
- End-stage cardiac disease or respiratory failure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Building Patient Capability for Managing Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia
Aim of this study is to evaluate the effect of conducting self-management interventions on severity of lower urinary tract symptoms (LUTS) for patients with benign prostatic hyperplasia (BPH).
Research hypothesis:
To fulfill the aim of this study, the following research hypothesis was formulated:
Patients with benign prostatic hyperplasia will suffer less lower urinary tract symptoms (LUTS) after conducting self-management intervention than before conducting.
Read the detailed description
Research design: Quasi-experimental (pre-posttest) research design was utilized to conduct this study.
This study was conducted at Assiut Urology and Nephrology Hospital. A purposive sample of 60 adult male patients diagnosed with benign prostatic hyperplasia were older than 40 years old, had no other factors influencing their urination, such as prostate cancer.
Patients had been assessed at base line using the following tools:
Tool (I): A structured interview questionnaire. Tool (II): International Prostate Symptom Score (IPSS).
Each patient will be assessed before conducting self-management intervention for socio-demographic data, clinical data, and patients' knowledge regarding self-management using the tool I.
Each patient will be assessed for lower urinary tract symptoms before conducting self-management intervention using tool tool II(IPSS).
IPSS is a scoring system used to screen for and diagnose BPH as well as to monitor symptoms and guide decisions about how to manage the disease monitor lower urinary tract symptoms, It includes seven questions, about symptom of BPH.Each question had a range from 0 to 5 for its answer. Maximum score of 35 points. On the basis of total score, the symptoms were categorized into mild (0 -7), moderate (8-19), and severe (20-35).
After 3 months from conducting self-management intervention each patient was reassessed for clinical progression "severity" of lower urinary tract symptoms(LUTS)using (tools II).
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Self management
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self managementOther
patients will be assessed at base line using tool I,II Patients will receive self-management intervention in the form of sessions. Four to six patients in each session. Each session will last approximately 20 minutes
Session 1 :
- Introduction to the concept of self-management.
- Education/reassurance
- Managing fluid intake.
- Caffeine abstinence
- Alcohol advice
Session 2 :
- Adjusting medications
- Constipation advice.
- Strategies for dribbling. pelvic floor exercise.
- Double-voiding.
- Bladder re-training.
Session 3:
- Booster session All sessions are supported with a self-management booklet given in session. All patients will be reassessed after three months
| Study group | Role | What they receive |
|---|---|---|
| single group | Experimental | Research design:
Quasi-experimental, single group pre- posttest design was utilized in the study. all patients will be assessed for LUTS at base line then will be reassessed after three months.
Study variables:
The independent variable is self management intervention while the dependent variable is the severity of lower urinary tract symptoms. Receives: Other: Self management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of lower urinary tract symptoms of benign prostate hyperplasia.
Evaluate outcome of conducting self-management intervention sessions on clinical progression of lower urinary tract symptoms of benign prostate hyperplasia.
through assessing
Lower urinary tract symptoms of benign prostate hyperplasia before and after self-management intervention by using international prostate symptom score (IPSS)
The IPSS was developed by American Urological Association, 1992. Is a scoring system used to screen for and diagnose BPH as well as to monitor symptoms and guide decisions about how to manage the disease, It includes seven questions, about symptom of BPH that asked to the patients about how often they have. Each question had a range 5 from 0 to 5 for its answer. Maximum score of 35 points. On the basis of total score, the symptoms were categorized into mild (0 -7), moderate (8-19), and severe (20-35).
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start1 Jun 2023
- Primary completion1 Mar 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amna A. Desouky, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Amna A. Desouky, MD, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06051383
- Sponsor's protocol ID
- Self-management
- Status last verified
- Jan 2025
- First submitted
- 18 Sep 2023
- Last updated
- 29 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building Patient Capability for Managing Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia
- ClinicalTrials.gov ID
- NCT06051383
- Acronym / sponsor ID
- Self-management
- Conditions
- Benign Prostatic Hyperplasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Amna A. Desouky, MDUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 22 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim of this study is to evaluate the effect of conducting self-management interventions on severity of lower urinary tract symptoms (LUTS) for patients with benign prostatic hyperplasia (BPH).
Research hypothesis:
To fulfill the aim of this study, the following research hypothesis was formulated:
Patients with benign prostatic hyperplasia will suffer less lower urinary tract symptoms (LUTS) after conducting self-management intervention than before conducting.
Detailed description
Research design: Quasi-experimental (pre-posttest) research design was utilized to conduct this study.
This study was conducted at Assiut Urology and Nephrology Hospital. A purposive sample of 60 adult male patients diagnosed with benign prostatic hyperplasia were older than 40 years old, had no other factors influencing their urination, such as prostate cancer.
Patients had been assessed at base line using the following tools:
Tool (I): A structured interview questionnaire. Tool (II): International Prostate Symptom Score (IPSS).
Each patient will be assessed before conducting self-management intervention for socio-demographic data, clinical data, and patients' knowledge regarding self-management using the tool I.
Each patient will be assessed for lower urinary tract symptoms before conducting self-management intervention using tool tool II(IPSS).
IPSS is a scoring system used to screen for and diagnose BPH as well as to monitor symptoms and guide decisions about how to manage the disease monitor lower urinary tract symptoms, It includes seven questions, about symptom of BPH.Each question had a range from 0 to 5 for its answer. Maximum score of 35 points. On the basis of total score, the symptoms were categorized into mild (0 -7), moderate (8-19), and severe (20-35).
After 3 months from conducting self-management intervention each patient was reassessed for clinical progression "severity" of lower urinary tract symptoms(LUTS)using (tools II).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single group | Experimental | Other: Self managementResearch design: Quasi-experimental, single group pre- posttest design was utilized in the study. all patients will be assessed for LUTS at base line then will be reassessed after three months. Study variables: The independent variable is self management intervention while the dependent variable is the severity of lower urinary tract symptoms. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients.
- Men.
- Clinical diagnosis of benign prostatic hyperplasia.
Key exclusion criteria (4 listed)
- Prostate cancer.
- Severe symptoms necessitating surgical treatment.
- Uncontrolled diabetes.
- End-stage cardiac disease or respiratory failure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self managementpatients will be assessed at base line using tool I,II Patients will receive self-management intervention in the form of sessions. Four to six patients in each session. Each session will last approximately 20 minutes Session 1 : * Introduction to the concept of self-management. * Education/reassurance * Managing fluid intake. * Caffeine abstinence * Alcohol advice Session 2 : * Adjusting medications * Constipation advice. * Strategies for dribbling. pelvic floor exercise. * Double-voiding. * Bladder re-training. Session 3: • Booster session All sessions are supported with a self-management booklet given in session. All patients will be reassessed after three months | Other | single group |
Primary outcome
Severity of lower urinary tract symptoms of benign prostate hyperplasia.
Time frame: Three months
Evaluate outcome of conducting self-management intervention sessions on clinical progression of lower urinary tract symptoms of benign prostate hyperplasia. through assessing Lower urinary tract symptoms of benign prostate hyperplasia before and after self-management intervention by using international prostate symptom score (IPSS) The IPSS was developed by American Urological Association, 1992. Is a scoring system used to screen for and diagnose BPH as well as to monitor symptoms and guide decisions about how to manage the disease, It includes seven questions, about symptom of BPH that asked to the patients about how often they have. Each question had a range 5 from 0 to 5 for its answer. Maximum score of 35 points. On the basis of total score, the symptoms were categorized into mild (0 -7), moderate (8-19), and severe (20-35).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self management in people with Benign Prostatic Hyperplasia, run by Amna A. Desouky, MD at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of lower urinary tract symptoms of benign prostate hyperplasia. (time frame: Three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2025.