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

Effectiveness of Intermittent Bladder Catheterization (IBC) in Reducing Recurrence of Urethral Stricture Among Female Patients in Tertiary Care Hospital, Lahore: A Nurse Led Intervention

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Urethral Stricture
• Intervention / Treatment: Other: Intermittent bladder catheterization

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.

• Study Type: Interventional
• Enrollment (Estimated): 54
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Other: Intermittent bladder catheterization; Intermittent bladder catheterization will be taught and performed by intervention group twice daily.
Active Comparator: 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.	Other: Intermittent bladder catheterization; Intermittent bladder catheterization will be taught and performed by intervention group twice daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
uretheral stricture recurrence	will be measured by AUA scoring system and visual analogue pain scale	Total 8 week (every 15 day follow up)

Collaborators and Investigators

• Sponsor: University of Health Sciences Lahore

Study record dates

Study Major Dates

• Study Start (Estimated): March 20, 2024
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: September 26, 2023
• First Submitted That Met QC Criteria: October 2, 2023
• First Posted (Actual): October 3, 2023

Study Record Updates

• Last Update Posted (Actual): December 22, 2023
• Last Update Submitted That Met QC Criteria: December 21, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Pathological Conditions, Anatomical; Urethral Diseases; Urethral Obstruction; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Recurrence; Constriction, Pathologic; Urethral Stricture
• Other Study ID Numbers: US RCT 001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No