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Effectiveness of Intermittent Bladder Catheterization (IBC) in Reducing Recurrence of Urethral Stricture Among Female Patients

Primary Purpose

Urethral Stricture

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intermittent bladder catherization
Sponsored by
University of Health Sciences Lahore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Urethral Stricture

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Female patients with diagnosis of urethral stricture. Age between 35 - 65 years. Females with Body mass index (BMI) < 30. Female without any psychiatric illness whose Abbreviated Mental Test Score [AMTS] lies between 7-10. Females with moderate to severe urinary symptoms score which lies between 8-35, on American Urological Association (AUA) symptom score. Underwent urethral dilation at least once by urologist with subsequent advice of Intermittent Bladder Catheterization (IBC) by trained nurse. At presentation >14Fr nelton catheter could passed per urethra for Intermittent Bladder Catheterization (IBC). Female who can read Urdu or English will be included. Exclusion Criteria: Any patient with concomitant bladder or urethral pathology other than urethral stricture. Patients unable to perform Intermittent Bladder Catheterization (IBC) due to any physical disability.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    intervention group

    Control group

    Arm Description

    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

    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.

    Outcomes

    Primary Outcome Measures

    uretheral stricture recurrence

    Secondary Outcome Measures

    Full Information

    First Posted
    September 26, 2023
    Last Updated
    October 2, 2023
    Sponsor
    University of Health Sciences Lahore
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06064968
    Brief Title
    Effectiveness of Intermittent Bladder Catheterization (IBC) in Reducing Recurrence of Urethral Stricture Among Female Patients
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    December 1, 2023 (Anticipated)
    Study Completion Date
    February 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Health Sciences Lahore

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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 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.
    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 (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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Urethral Stricture

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Intervention and control group
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    54 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    intervention group
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Control group
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Intermittent bladder catherization
    Intervention Description
    Intermittent bladder catherization will be taught and performed by intervention group twice daily.
    Primary Outcome Measure Information:
    Title
    uretheral stricture recurrence
    Time Frame
    Total 8 week (every 15 day follow up)

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Minimum Age & Unit of Time
    35 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Female patients with diagnosis of urethral stricture. Age between 35 - 65 years. Females with Body mass index (BMI) < 30. Female without any psychiatric illness whose Abbreviated Mental Test Score [AMTS] lies between 7-10. Females with moderate to severe urinary symptoms score which lies between 8-35, on American Urological Association (AUA) symptom score. Underwent urethral dilation at least once by urologist with subsequent advice of Intermittent Bladder Catheterization (IBC) by trained nurse. At presentation >14Fr nelton catheter could passed per urethra for Intermittent Bladder Catheterization (IBC). Female who can read Urdu or English will be included. Exclusion Criteria: Any patient with concomitant bladder or urethral pathology other than urethral stricture. Patients unable to perform Intermittent Bladder Catheterization (IBC) due to any physical disability.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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