NCT06051383

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 18, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 22, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

January 29, 2025

Status Verified

January 1, 2025

Enrollment Period

9 months

First QC Date

September 18, 2023

Last Update Submit

January 27, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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).

    Three months

Study Arms (1)

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.

Other: Self management

Interventions

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

single group

Eligibility Criteria

Age40 Years - 65 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale patients diagnosed with benign prostatic hyperplasia
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Nursing

Asyut, 71111, Egypt

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Self-Management

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

RehabilitationHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor of Medical Surgical Nursing

Study Record Dates

First Submitted

September 18, 2023

First Posted

September 22, 2023

Study Start

June 1, 2023

Primary Completion

March 1, 2024

Study Completion

July 1, 2024

Last Updated

January 29, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations