A prospective, observational study to compare the effectiveness of self-administered patient questionnaires, the International Prostate Symptom Score (IPSS) and the Visual Prostate Symptom Score (VPSS), in evaluating lower urinary tract symptoms in patients with benign prostatic enlargement.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Validation of VPSS as a simplified alternative to IPSS, focusing on its reduced number of questions and use of pictorial aids.
研究概览
简要总结
Benign Prostatic Hyperplasia (BPH) is a common condition in aging men, with a global prevalence of 20–62% in men over 50 years. It leads to lower urinary tract symptoms (LUTS) such as reduced urinary frequency, urgency, nocturia, hesitancy, and incomplete bladder emptying, impacting quality of life. The primary objectives of this study are to compare the diagnostic effectiveness of the International Prostate Symptom Score (IPSS) and Visual Prostate Symptom Score (VPSS) in evaluating LUTS, correlate these scores with uroflowmetry results, assess the impact of education and age on their completion, and analyze the time taken for completion. The secondary objectives include validating VPSS as a simplified alternative to IPSS by introducing a new severity grading system, assessing patient preferences and ease of use, and improving clinician efficiency. The eligibility criteria include male patients over 45 years with LUTS, while excluding those with prior BPH treatment, neurological conditions, or other confounding urological issues. The intervention involves non-pharmacological assessments using IPSS and VPSS questionnaires. The rationale of the study is to evaluate VPSS as a reliable and simpler tool, particularly for populations with low literacy, compared to IPSS. The data collected will include education level, time taken to complete the forms, assistance required, uroflowmetry results, and patient feedback. The study duration is six months, with a sample size of 100 patients. The endpoints include validation of VPSS as a simplified alternative, development of a new severity grading system, and improved clinician efficiency in routine practice
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 45.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- Male
入选标准
- •Male patients older than 45 years of age.
- •Male patients who presented to the Urology OPD with chief complaint of Lower Urinary Tract Symptoms (LUTS).
- •Patients giving consent for taking part in the study.
排除标准
- •Patients who had undergone surgical treatment due to a diagnosis of Benign Prostatic Hyperplasia.
- •Patients who had been receiving medical treatment with a diagnosis of Benign Prostatic Hyperplasia.
- •Patients with urethral stricture.
- •Patients with a prostate-specific antigen (PSA) level above 4 ng/dl.
- •Patients with systemic neurological disease.
- •Patients with history of pelvic radiotherapy.
- •Patients who had been diagnosed with Neurogenic Bladder.
- •Patients with Vesical calculi, Cystitis/Urinary Tract Infection, Carcinoma Bladder.
- •Patients who are Blind/Visually impaired.
- •Patients with indwelling Per urethral or Suprapubic catheters.
- •Patients on Diuretic therapy.
结局指标
主要结局
Validation of VPSS as a simplified alternative to IPSS, focusing on its reduced number of questions and use of pictorial aids.
时间窗: on week 24.
Development and validation of a new severity grading system for VPSS to improve its diagnostic capability in the Indian context.
时间窗: on week 24.
Patient preference and ease of use of VPSS compared to IPSS, evaluated through feedback and completion rates.
时间窗: on week 24.
Overall clinician efficiency improvement by utilizing VPSS in routine practice.
时间窗: on week 24.
次要结局
未报告次要终点
研究者
Dr Sivaprasad Gourabathini
Bhaktivedanta Hospital and Research Institute