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Clinical Trials/NCT06051383
NCT06051383CompletedNot Applicable

Building Patient Capability for Managing Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia

Amna A. Desouky, MD1 site in 1 country60 target enrollmentStarted: June 1, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
Severity of lower urinary tract symptoms of benign prostate hyperplasia.

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
40 Years to 65 Years (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Adult patients.
  • Clinical diagnosis of benign prostatic hyperplasia.

Exclusion Criteria

  • Prostate cancer.
  • Severe symptoms necessitating surgical treatment.
  • Uncontrolled diabetes.
  • End-stage cardiac disease or respiratory failure.

Arms & Interventions

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.

Intervention: Self management (Other)

Outcomes

Primary Outcomes

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).

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Amna A. Desouky, MD
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Amna A. Desouky, MD

Assistant Professor of Medical Surgical Nursing

Assiut University

Study Sites (1)

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