Predictors of persistent lower urinary tract symptoms post TURP: a prospective study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Following clinical and urodynamic variables will be compared between the patients of two groups – Persistent LUTS or No LUTS, to preoperatively predict persistence of LUTS.
研究概览
简要总结
· The present study will include 114 patients presenting to Kasturba Hospital, Manipal with Bothersome LUTS and undergoing TURP after meeting the inclusion and exclusion criteria. Informed consent will be obtained for collection of data in patient’s own vernacular language. Detailed history and clinical examination will be done.
· Patient’s predominant symptom, age, BMI, any comorbidity, DRE findings will be noted. Further preoperative workup will be done – including IPSS (including sub score IPSS-S, IPSS-V) and QoL, USG KUB to look for prostate size and IVPP, Uroflowmetry with PVR, UDS (if indicated).
· Patient will undergo TURP. Intraoperative findings and HPE will be noted.
· Patient will be followed up at 3rd month.
· At follow up patient will be divided into two groups – Patients with persistent bothersome LUTS or patient with No LUTS
· Patients having persistent bothersome LUTS post TURP will be evaluated with thorough history and physical examination including IPSS (including sub score IPSS-S, IPSS-V), QoL, Urine culture. Noninvasive uroflowmetry with post-void residual, and subsequent urodynamic study or cystoscopy will be utilized as needed.
· Patients having persistent LUTS related to TURP complications will be excluded from study.
· Statistical analysis will be done between the two groups to find the predictors of persistence LUTS post TURP.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- Male
入选标准
- •Patients undergoing TURP 1.Severe LUTS with failed medical management 2.AUR which is refractory or recurrent 3.CUR which is either LPCR, HPCR 4.Vesical calculi, recurrent UTIs, recurrent hematuria which are BPE related complications.
排除标准
- •1.Previous prostate surgery 2.Urethral stricture 3.Prostate cancer 4.TCC Bladder 5.Persistent LUTS due to TURP complications like bladder neck contracture, urethral stricture, inadequate resection.
结局指标
主要结局
Following clinical and urodynamic variables will be compared between the patients of two groups – Persistent LUTS or No LUTS, to preoperatively predict persistence of LUTS.
时间窗: Baseline and 3 months
1.Mean age and comorbidity
时间窗: Baseline and 3 months
2.Pre and post-operative IPSS (including sub score IPSS-S, IPSS-V), QoL
时间窗: Baseline and 3 months
3.Prostatic volume and IVPP
时间窗: Baseline and 3 months
4.Uroflowmetry – Qmax, PVR
时间窗: Baseline and 3 months
5.UDS (wherever indicated)
时间窗: Baseline and 3 months
次要结局
- To look what modality of treatment is offered to the patients which presented with persistent LUTS post TURP(3 months)
研究者
Dr. Ankit Agarwal
Kasturba Medical college, Manipal