Urethral StrictureNCT06064968
Effectiveness of Intermittent Bladder Catheterization (IBC) in Reducing Recurrence of Urethral Stricture
A study testing Intermittent bladder catheterization in people with Urethral Stricture, run by University of Health Sciences Lahore at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 35 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urethral Stricture
- What is being tested?
- Intermittent bladder catheterization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Jun 2024to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Urethral Stricture
- Being tested
- Intermittent bladder catheterization
- Medical subject headings
- Urethral Stricture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent bladder catheterizationOther
Intermittent bladder catheterization will be taught and performed by intervention group twice daily.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: Intermittent bladder catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
uretheral stricture recurrence
will be measured by AUA scoring system and visual analogue pain scale
Measured: Total 8 week (every 15 day follow up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study start20 Jun 2024
- Primary completion1 Sep 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urethral StrictureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention and control group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Health Sciences Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Farah Naz, University of Health Sciences Lahore
- Investigators
- Dr.sabhee UbaidUllah, Study director, Fauji foundation Lahore cantt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06064968
- Sponsor's protocol ID
- US RCT 001
- Status last verified
- May 2024
- First submitted
- 26 Sep 2023
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Naz F, Kausar S, Rahim J, Taj S. Effect of Nurse-Led Intermittent Bladder Catheterization on Recurrence of Female Urethral Stricture following Urethral Dilatation: A Randomized Controlled Trial. Pak J Med Sci. 2026 May;42(5):1087-1091. doi: 10.12669/pjms.42.5.12309.
PubMed 42305123
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06064968
- Acronym / sponsor ID
- US RCT 001
- Conditions
- Urethral Stricture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of Health Sciences LahoreUniversity, hospital or other
- Study start
- 20 Jun 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 3 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention and control group
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: Intermittent bladder catheterizationIn 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 |
| Control group | Active comparator | Other: Intermittent bladder catheterizationIn 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. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent bladder catheterizationIntermittent bladder catheterization will be taught and performed by intervention group twice daily. | Other | Control group, intervention group |
Primary outcome
uretheral stricture recurrence
Time frame: Total 8 week (every 15 day follow up)
will be measured by AUA scoring system and visual analogue pain scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Derived from this study: PubMed 42305123Naz F, Kausar S, Rahim J, Taj S. Effect of Nurse-Led Intermittent Bladder Catheterization on Recurrence of Female Urethral Stricture following Urethral Dilatation: A Randomized Controlled Trial. Pak J Med Sci. 2026 May;42(5):1087-1091. doi: 10.12669/pjms.42.5.12309.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr.sabhee UbaidUllah study director
Fauji foundation Lahore cantt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent bladder catheterization in people with Urethral Stricture, run by University of Health Sciences Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
uretheral stricture recurrence (time frame: Total 8 week (every 15 day follow up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06064968, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.