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

Sponsor
Amna A. Desouky, MD (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT06051383
Collaborator
(none)
60
1
1
13
4.6

Study Details

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
  • Other: Self management
N/A

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
Anticipated 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 :
Jun 1, 2023
Anticipated Primary Completion Date :
Nov 15, 2023
Anticipated Study Completion Date :
Jul 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. [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

Criteria

Ages Eligible for Study:
40 Years to 65 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Site City State Country Postal Code
1 Faculty of Nursing Assiut Egypt 71111

Sponsors and Collaborators

  • Amna A. Desouky, MD

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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:
Sep 22, 2023
Last Update Posted:
Sep 22, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
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:

Study Results

No Results Posted as of Sep 22, 2023