Ignite Creation Date:
2024-05-06 @ 7:34 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06064968
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-29
First Post:
2023-09-26
Brief Title:
Effectiveness of Intermittent Bladder Catheterization IBC in Reducing Recurrence of Urethral Stricture
Sponsor:
University of Health Sciences Lahore
Organization:
University of Health Sciences Lahore
Study Overview
Official Title:
Effectiveness of Intermittent Bladder Catheterization IBC in Reducing Recurrence of Urethral Stricture Among Female Patients in Tertiary Care Hospital Lahore A Nurse Led Intervention
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this randomized controlled trial is to To assess the effectiveness of intermittent bladder catheterization IBC in reducing the recurrence of urethral stricture among females in tertiary care hospital Lahore
All the patient who have undergone urethral dilation by urologist will be divided into two groups ie intervention group and control group
In control group already diagnosed cases of urethral stenosis who have undergone urethral dilatation will be followed fortnightly for AUA symptoms scoring for urinary complaints and urethral catheterization with nelton 14 Fr to exclude urethral stricture recurrence
In intervention group researcher will explain the patient about the intermittent catheterization technique and give the practical demonstration for better patient understanding and make correction in patients technique of intermittent bladder catheterization
Patient will be followed from the day of recruitment in the study after every 02 weeks by the researcher for 2 successive months
In every follow up session assessment of the urinary complaints via AUA scoring review of patients technique of urethral catheterization in intervention group and each patients adherence to the intermittent bladder catheterization IBC will be noted
All the patient who have undergone urethral dilation by urologist will be divided into two groups ie intervention group and control group
In control group already diagnosed cases of urethral stenosis who have undergone urethral dilatation will be followed fortnightly for AUA symptoms scoring for urinary complaints and urethral catheterization with nelton 14 Fr to exclude urethral stricture recurrence
In intervention group researcher will explain the patient about the intermittent catheterization technique and give the practical demonstration for better patient understanding and make correction in patients technique of intermittent bladder catheterization
Patient will be followed from the day of recruitment in the study after every 02 weeks by the researcher for 2 successive months
In every follow up session assessment of the urinary complaints via AUA scoring review of patients technique of urethral catheterization in intervention group and each patients adherence to the intermittent bladder catheterization IBC will be noted
Detailed Description:
Urethral stricture is a known pathology with significant health related issues ranging from mild lower urinary tract symptoms to severe urinary retention or even renal failure Female urethral stricture FUS is under reported in literature This low prevalence 4-18 is due to lack of standard definition of the said disease well-established diagnostic criteria and single effective treatment Internationally variety of literature is available on treatment of urethral stricture with urethral dilation with or without intermittent catheterization with wide range of disparity in recurrence rates ie 43 with urethral dilation with IBC to 94 with urethral dilatation without IBC On national level urethral stricture disease is frequently seen in clinical practice however there is lack of any published data on disease management and follow up Intermittent bladder catheterization is an acceptable mean to prevent recurrence and easy-to-perform by the patients themselves this study is therefore designed to assess whether intermittent bladder catheterization is effective or not in lowering the disease recurrence in patients with urethral stricture following urethral dilation Aim of this study is to assess the effectiveness intermittent bladder catheterization IBC led by urology care nurse in reducing the rate of recurrence of urethral stricture in females following urethral dilation A randomized controlled trial will be conducted and patients meeting inclusion criteria will be allocated in two groups by block randomization ie a control group and the intervention group Duration of study will be 6 months after approval of synopsis Females already diagnosed with urethral stricture disease who have undergone urethral dilatation at least once by urologist age between 35- 65 years BMI 30 Abbreviated Mental Test Score AMTS between 7-10 and American Urological Association AUA symptom score between 8 -35 will be included in this study Data will be analyzed by SPSS version 23 Descriptive statistics frequencies percentages etc will be used to describe the socio-demographic characteristics of study population Independent t-test will be used to compare the mean difference between the groups for AUA score AMTS score and pain VAS score Repeated measure ANOVA will be used to compare the mean score within the group for weekly follow up Significance level p value of the test will be 005 Findings of this study will help in establishing incidence of FUS disease and help in estimation of its actual recurrence This will also help in incorporating IBC in general nursing care for the patients who need it It will also be helpful in reducing number of OPD visits length of hospital stay and overall financial burden on health care system
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None