- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06051383
Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Assiut, Egypt, 71111
- Faculty of nursing
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion:
- Adult patients.
- Men.
- Clinical diagnosis of benign prostatic hyperplasia.
Exclusion:
- Prostate cancer.
- Severe symptoms necessitating surgical treatment.
- Uncontrolled diabetes.
- End-stage cardiac disease or respiratory failure.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: single group
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. |
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 :
Session 2 :
Session 3: • Booster session All sessions are supported with a self-management booklet given in session. All patients will be reassessed after three months |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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). |
Three months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Self-management
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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