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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06051383
Recruitment Status : Active, not recruiting
First Posted : September 22, 2023
Last Update Posted : January 5, 2024
Sponsor:
Information provided by (Responsible Party):
Amna A. Desouky, MD, Assiut University

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).

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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 : February 1, 2024
Estimated Study Completion Date : June 1, 2024

Resource links provided by the National Library of Medicine


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





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).




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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Male patients diagnosed with benign prostatic hyperplasia
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion:

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

Exclusion:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06051383


Locations
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Egypt
Faculty of Nursing
Assiut, Egypt, 71111
Sponsors and Collaborators
Amna A. Desouky, MD
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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    Key Record Dates
Last Update Posted: January 5, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Hyperplasia
Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Male Urogenital Diseases