Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06064968 |
| Other study ID # |
US RCT 001 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 20, 2024 |
| Est. completion date |
October 1, 2024 |
Study information
| Verified date |
May 2024 |
| Source |
University of Health Sciences Lahore |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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 i.e. 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 patient's 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
patient's technique of urethral catheterization in intervention group, and each patient's
adherence to the intermittent bladder catheterization (IBC) will be noted.
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 (i.e. 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 i.e. 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 0.05.
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.
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