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

NCT ID: NCT06064968

Last Updated: 2024-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-20

Study Completion Date

2024-10-01

Brief Summary

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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

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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.

Conditions

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Urethral Stricture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Intervention and control group
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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intervention group

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

Group Type EXPERIMENTAL

Intermittent bladder catheterization

Intervention Type OTHER

Intermittent bladder catheterization will be taught and performed by intervention group twice daily.

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.

Group Type ACTIVE_COMPARATOR

Intermittent bladder catheterization

Intervention Type OTHER

Intermittent bladder catheterization will be taught and performed by intervention group twice daily.

Interventions

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Intermittent bladder catheterization

Intermittent bladder catheterization will be taught and performed by intervention group twice daily.

Intervention Type OTHER

Eligibility Criteria

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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 nelaton 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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Health Sciences Lahore

OTHER

Sponsor Role lead

Responsible Party

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Farah Naz

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dr.sabhee UbaidUllah

Role: STUDY_DIRECTOR

Fauji foundation Lahore cantt

Locations

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UHS

Lahore, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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US RCT 001

Identifier Type: -

Identifier Source: org_study_id