Outcome of Conducting Self-management Intervention on Clinical Progression of Benign Prostatic Hyperplasia

• ClinicalTrials.gov Identifier: NCT06051383
• Recruitment Status: Active, not recruiting
• First Posted: September 22, 2023
• Last Update Posted: September 22, 2023
• Sponsor: Amna A. Desouky, MD
• Information provided by (Responsible Party): Amna A. Desouky, MD, Assiut University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Benign Prostatic Hyperplasia	Other: Self management	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Outcome of Conducting Self-Management Intervention on Clinical Progression of Benign Prostatic Hyperplasia
• Actual Study Start Date: June 1, 2023
• Estimated Primary Completion Date: November 15, 2023
• Estimated Study Completion Date: July 1, 2024

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures :

1. 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).

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Gender Based Eligibility: Yes
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

older than 40 years old had no other factors influencing their urination, such as prostate cancer.

• Exclusion Criteria:

Uncontrolled diabetes, sever symptoms requiring surgical treatment End-stage cardiac disease or respiratory failure. Psychic disease, Dementia,

,

Contacts and Locations

Locations

Egypt

Faculty of Nursing

Assiut, Egypt, 71111

Sponsors and Collaborators

Amna A. Desouky, MD

More Information

• Responsible Party: Amna A. Desouky, MD, Assistant Professor of Medical Surgical Nursing, Assiut University
• ClinicalTrials.gov Identifier: NCT06051383
• Other Study ID Numbers: Self-management
• First Posted: September 22, 2023
• Last Update Posted: September 22, 2023
• Last Verified: September 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Prostatic Hyperplasia; Hyperplasia; Pathologic Processes; Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases