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

NCT06064968 | Completed

• 1 other identifier: US RCT 001
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Urethral Stricture

Outcome Measures

Primary Outcomes (1)

• uretheral stricture recurrence

  will be measured by AUA scoring system and visual analogue pain scale

  Total 8 week (every 15 day follow up)

Study Arms (2)

intervention group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Interventions

Intermittent bladder catheterization OTHER

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

Control group; intervention group

Eligibility Criteria

• Age: 35 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Health Sciences Lahore: lead

Study Sites (1)

UHS

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Urethral Stricture

Condition Hierarchy (Ancestors)

Urethral Obstruction; Urethral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Dr.sabhee UbaidUllah

  Fauji foundation Lahore cantt

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Intervention and control group

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: October 3, 2023
• Study Start: June 20, 2024
• Primary Completion: September 1, 2024
• Study Completion: October 1, 2024
• Last Updated: December 11, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)