search
Back to results

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

Primary Purpose

Benign Prostatic Hyperplasia

Status
Active
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Self management
Sponsored by
Amna A. Desouky, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Benign Prostatic Hyperplasia

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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, ,

Sites / Locations

  • Faculty of Nursing

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

single group

Arm Description

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
September 18, 2023
Last Updated
September 21, 2023
Sponsor
Amna A. Desouky, MD
search

1. Study Identification

Unique Protocol Identification Number
NCT06051383
Brief Title
Outcome of Conducting Self-management Intervention on Clinical Progression of Benign Prostatic Hyperplasia
Official Title
Outcome of Conducting Self-Management Intervention on Clinical Progression of Benign Prostatic Hyperplasia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
November 15, 2023 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Amna A. Desouky, MD

4. Oversight

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

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
single group
Arm Type
Experimental
Arm Description
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 Type
Other
Intervention Name(s)
Self management
Intervention Description
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
Primary Outcome Measure Information:
Title
Severity of lower urinary tract symptoms of benign prostate hyperplasia.
Description
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).
Time Frame
Three months

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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, ,
Facility Information:
Facility Name
Faculty of Nursing
City
Assiut
ZIP/Postal Code
71111
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs