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 : September 22, 2023
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).
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|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|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|
Experimental: single group
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.
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 :
Session 2 :
• Booster session All sessions are supported with a self-management booklet given in session. All patients will be reassessed after three months
- 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.
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).
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
|Faculty of Nursing|
|Assiut, Egypt, 71111|