Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia
Building Patient Capability for Managing Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia
1 other identifier
interventional
60
1 country
1
Brief 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). 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2023
CompletedFirst Submitted
Initial submission to the registry
September 18, 2023
CompletedFirst Posted
Study publicly available on registry
September 22, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2024
CompletedJanuary 29, 2025
January 1, 2025
9 months
September 18, 2023
January 27, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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).
Three months
Study Arms (1)
single group
EXPERIMENTALResearch 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.
Interventions
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
Eligibility Criteria
You may qualify if:
- Adult patients.
- Men.
- Clinical diagnosis of benign prostatic hyperplasia.
You may not qualify if:
- Prostate cancer.
- Severe symptoms necessitating surgical treatment.
- Uncontrolled diabetes.
- End-stage cardiac disease or respiratory failure.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Nursing
Asyut, 71111, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor of Medical Surgical Nursing
Study Record Dates
First Submitted
September 18, 2023
First Posted
September 22, 2023
Study Start
June 1, 2023
Primary Completion
March 1, 2024
Study Completion
July 1, 2024
Last Updated
January 29, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share