Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia

NCT ID: NCT06051383

Last Updated: 2025-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2024-07-01

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Self management

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Amna A. Desouky, MD

OTHER

Sponsor Role: lead

Responsible Party

Amna A. Desouky, MD

Assistant Professor of Medical Surgical Nursing

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Faculty of Nursing

Asyut, , Egypt

Countries

Egypt

Other Identifiers

Self-management

Identifier Type: -

Identifier Source: org_study_id