Outcome of Conducting Self-management Intervention on Severity of Lower Urinary Tract Symptoms

Benign Prostatic Hyperplasia Clinical Trial

Official title:

Outcome of Conducting Self-Management Intervention on Severity of Lower Urinary Tract Symptoms

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06051383
• Other study ID #: Self-management
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: May 2024
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: July 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Lower Urinary Tract Symptoms
• Prostatic Hyperplasia

Intervention

Other:
• Self management
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

Locations

Country	Name	City	State
Egypt	Faculty of Nursing	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Amna A. Desouky, MD

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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