跳至主要内容
临床试验/CTRI/2024/10/074802
CTRI/2024/10/074802尚未招募不适用

Comprehensive Prospective Assessment Of Patient Reported Outcome Measures PROMs And Patient Reported Experience Measures PREMs For Non traumatic Bulbar Urethral Stricture Patients Undergoing Urethroplasty and Visual Internal Urethrotomy In Indian Population A Tertiary Health Care Centre Study.

Kasturba Medical College Manipal Department of Urology and Renal transplant1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年10月7日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Correlation of modified PROM(Jackson et al; ) and modified PREM questionnaire (Jenkinson et al;) with clinical outcomes using quality of health via visual analogue quality of life health scale following urethroplasty and VIU in non traumatic bulbar urethral stricture patients

研究概览

简要总结

Non traumatic Bulbar Urethral stricture disease can have a significant negative impact on patient quality of life. Treatment is tailored for each individual patient and depends on the aetiology, stricture location, length, and degree of associated spongiofibrosis ,choice of surgical technique based on the location and length of the stricture, as well as on surgeon preference.

This study highlights the importance of PROMs and PREMs in urethral reconstructive surgery, emphasizing that success should not be defined only by stricture-free survival, but also there exists clear impetus to align and implement international PROM and PREM programs collectively together to enable global health system performance measurement and to collectively drive patient-centred, value based healthcare thus improving the health outcomes following Urethroplasty and Visual Internal Urethrotomy

The study will be only conducted only after obtaining permission from the institutional ethical committee. Confidentiality of data of patients will be maintained. The investigations done will be a part of routine procedure under standard protocol for the management of urethral stricture. Patients with urethral stricture disease will be initially assessed using the inclusion and exclusion criteria mentioned in the above protocol and non traumatic bulbar urethral stricture patients will be selected and recruited in the study after taking written informed consent. Patients will undergo surgical intervention(Urethroplasty/VIU) based on surgeon’choice. Assessment of health outcomes using Assessment of health outcome using Modified PROM(Jackson et al;) and modified PREM questionnaire(Jenkinson et al;) for patients undergoing Urethroplasty and Visual internal Urethrotomy will be done preoperatively as well as postoperatively at POD-1,3,6 and 12 months followup period will be done, accordingly loss to followup and drop up rate will be assessed. Statistical Analysis will be calculated using STATA/SPSS Software version 21. Correlation of modified PROM (Jackson et al; ) modified PREM questionnaire(Jenkinson et al;) with patient -based health outcomes and quality of life via visual analogue quality of lifehealth scale will be done . Stricture free outcome rates will be assessed on followups. Recurrence rate will be assessed accordingly in patients reporting worst health outcomes(quality of life) by means of cystourethroscopy and uroflowmetry.

Type of study:Prospective -Longitudinal study .As study is being conducted for a period of one year ,the desired sample size may not be able to achieve(85 subjects in each group), hence the study is made time bound.

Potential benefits : There will be an benefit in improving overall quality of life in patients undergoing urethroplasty and Visual internal urethrotomy for non-traumatic bulbar urethral strictures by integrating the PREM and PROM questionnaire in the Indian health system thus improvising the existing standard existing system for a better outcome. Risks: Anxiety related issues while filling the questionnaire. No additional risks apart from the standard risks associated with the procedure (Urethroplasty or Visual internal urethrotomy.

Tools used :Modified PROM (Jackson et al; ) ,Modified PREM questionnaires (Jenkinson et al;) and visual analogue quality of life health scale for non-traumatic bulbar urethral stricture willing to undergo Urethroplasty and Visual Internal Urethrotomy. Radiological investigations: Ascending urethrogram, Micturating Cystourethrogram. Functional urological investigations: Uroflowmetry. Other diagnostic investigations :Cystourethroscopy .

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
Male

入选标准

  • All non-traumatic bulbar urethral stricture male patients aged more than 18 years and above with no previous history of urethroplasty admitted in Department of Urology in Kasturba Medical college Manipal willing to undergo Urethroplasty and Visual Internal Urethrotomy .

排除标准

  • Patients who undergo staged urethroplasty .
  • Recurrent non traumatic bulbar urethral stricture urethral patients following urethroplasty in the past.

结局指标

主要结局

Correlation of modified PROM(Jackson et al; ) and modified PREM questionnaire (Jenkinson et al;) with clinical outcomes using quality of health via visual analogue quality of life health scale following urethroplasty and VIU in non traumatic bulbar urethral stricture patients

时间窗: Baseline data -preoperatively | Postoperatively on Day 1, 3monthS, 6months ,12 months respectively.

次要结局

  • Stricture free outcome for Urethroplasty & Visual internal urethrotomy will be assessed by(uroflowmetry & cystourethroscopy in patients reporting worst health outcomes .)

研究者

发起方
Kasturba Medical College Manipal Department of Urology and Renal transplant
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Sanjith Kamath N

Kasturba Medical College Manipal

研究点 (1)

Loading locations...

相似试验