Bacteriuria in Symptomatic Benign Prostate HyperplasiaBPHNCT06520267
Prevalence of Bacteriuria, Antibiotic Susceptibility, and Treatment Response in Symptomatic Benign Prostatic Hyperplasia
An observational study of Bacteriuria in Symptomatic Benign Prostate Hyperplasia and Antibiotic Susceptibility in Symptomatic Benign Prostate Hyperplasia, run by Tribhuvan University Teaching Hospital, Institute Of Medicine. at 1 site in Nepal.
Trial summary
The goal of this prospective observational study is to identify the common pathogens and antibiotic sensitivity pattern in urine samples of men with symptomatic BPH and to assess severity of LUTS in patients with symptomatic BPH using IPSS score before and after antibiotic therapy. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Bacteriuria in Symptomatic Benign Prostate Hyperplasia, Antibiotic Susceptibility in Symptomatic Benign Prostate Hyperplasia, Treatment Response to Antibiotics in Symptomatic Benign Prostate Hyperplasia
- What is being tested?
- Antibiotic therapy
- How many people
- 131 participants
- Where
- 1 siteNepal
- Study dates
- 1 Sep 2020to 15 Aug 2021
- How long will I take part?
- 4 Weeks
- Phase
- Observational
- 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 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: All patients with symptomatic BPH attending the Urology Out-Patient Department (OPD) of the study site were enrolled. Informed and written consent was obtained from all participants. Demographic data were recorded, and detailed histories were taken. IPSS scoring was conducted. A thorough clinical examination, including general physical, systemic, and digital rectal examination, was performed. During the rectal examination, the prostate was checked for nodules, softness, induration, or tenderness. Urine culture and antibiotic sensitivity tests were conducted to assess the bacteriological profile. The patients was started on antibiotic therapy for a week based on antibiotic susceptibility testing.
Who may be able to join
- Patients with symptomatic BPH.
Who cannot join
- Patients with indwelling catheters
- Recent antibiotic use
- Immunocompromised states (e.g., HIV, HCV)
- Uncontrolled diabetes mellitus (Hemoglobin A1c > 7%)
- Steroid therapy
- Those who declined to provide consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Bacteriuria, Antibiotic Susceptibility, and Treatment Response in Patients With Symptomatic Benign Prostatic Hyperplasia: a Prospective Observational Study
The goal of this prospective observational study is to identify the common pathogens and antibiotic sensitivity pattern in urine samples of men with symptomatic BPH and to assess severity of LUTS in patients with symptomatic BPH using IPSS score before and after antibiotic therapy.
Read the detailed description
This was a hospital-based prospective observational study.
All patients with symptomatic BPH attending the Urology Out-Patient Department (OPD) of the study site were enrolled. Informed and written consent was obtained from all participants. Demographic data were recorded, and detailed histories were taken regarding the duration and symptoms of BPH, including incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining, nocturia, and relevant past history. IPSS scoring was conducted. A thorough clinical examination, including general physical, systemic, and digital rectal examination, was performed. During the rectal examination, the prostate was checked for nodules, softness, induration, or tenderness. Urine culture and antibiotic sensitivity tests were conducted to assess the bacteriological profile.
- Conditions
- Bacteriuria in Symptomatic Benign Prostate Hyperplasia, Antibiotic Susceptibility in Symptomatic Benign Prostate Hyperplasia, Treatment Response to Antibiotics in Symptomatic Benign Prostate Hyperplasia
- Being tested
- Antibiotic therapy
- Keywords
- Bacteriuria, Benign Prostate Hyperplasia, Urinary Tract Infection
- Medical subject headings
- Bacteriuria, Prostatic Hyperplasia, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antibiotic therapyDrug
Also called Antibiotics
Urine culture and antibiotic sensitivity tests were conducted to assess the bacteriological profile. The patients were then prescribed antibiotics based on susceptibility testing for a duration of 1 week.
| Study group | Role | What they receive |
|---|---|---|
| symptomatic BPH | All patients with symptomatic BPH attending the Urology Out-Patient Department (OPD) of the study site were enrolled. Informed and written consent was obtained from all participants. Demographic data were recorded, and detailed histories were taken regarding the duration and symptoms of BPH and relevant past history. IPSS scoring was conducted. A thorough clinical examination, including general physical, systemic, and digital rectal examination, was performed. During the rectal examination, the prostate was checked for nodules, softness, induration, or tenderness. Urine culture and antibiotic sensitivity tests were conducted to assess the bacteriological profile. Receives: Drug: Antibiotic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of common pathogens and Antibiotic susceptibility testing
Urine culture and antibiotic sensitivity tests were conducted to assess the bacteriological profile among symptomatic patients with BPH.
Measured: 4 weeks
Secondary outcomes (1)
Severity of LUTS in patients with symptomatic BPH
The study assess severity of LUTS in patients with symptomatic BPH using IPSS score before and after antibiotic therapy.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start1 Sep 2020
- Primary completion12 Jun 2021
- Study completion15 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacteriuria in Symptomatic Benign Prostate HyperplasiaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 131 participants (actual)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Tribhuvan University Teaching Hospital, Institute Of Medicine.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ishwor Thapaliya, Tribhuvan University Teaching Hospital, Institute Of Medicine.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06520267
- Sponsor's protocol ID
- IRC/1694/019
- Acronym
- BPH
- Status last verified
- Jul 2024
- First submitted
- 21 Jul 2024
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Individual Participant Data (IPD) to be shared from this study will encompass demographic details (age, sex), clinical characteristics (severity and duration of lower urinary tract symptoms, baseline IPSS scores), microbiological findings (bacterial species isolated from urine cultures, antibiotic sensitivity patterns), treatment information (antibiotic regimen and duration), and clinical outcomes (post-treatment IPSS scores, follow-up urine culture results). This comprehensive dataset will facilitate in-depth analysis of the impact of antibiotic therapy on symptom relief and bacteriuria in patients with symptomatic Benign Prostatic Hyperplasia (BPH), thereby supporting future research and enhancing clinical management strategies.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Bacteriuria, Antibiotic Susceptibility, and Treatment Response in Patients With Symptomatic Benign Prostatic Hyperplasia: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06520267
- Acronym / sponsor ID
- BPH / IRC/1694/019
- Conditions
- Bacteriuria in Symptomatic Benign Prostate Hyperplasia, Antibiotic Susceptibility in Symptomatic Benign Prostate Hyperplasia, Treatment Response to Antibiotics in Symptomatic Benign Prostate Hyperplasia
- Keywords
- Bacteriuria, Benign Prostate Hyperplasia, Urinary Tract Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Tribhuvan University Teaching Hospital, Institute Of Medicine.University, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 12 Jun 2021 (actual)
- Study completion
- 15 Aug 2021 (actual)
- First posted
- 25 Jul 2024 (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 prospective observational study is to identify the common pathogens and antibiotic sensitivity pattern in urine samples of men with symptomatic BPH and to assess severity of LUTS in patients with symptomatic BPH using IPSS score before and after antibiotic therapy.
Detailed description
This was a hospital-based prospective observational study.
All patients with symptomatic BPH attending the Urology Out-Patient Department (OPD) of the study site were enrolled. Informed and written consent was obtained from all participants. Demographic data were recorded, and detailed histories were taken regarding the duration and symptoms of BPH, including incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining, nocturia, and relevant past history. IPSS scoring was conducted. A thorough clinical examination, including general physical, systemic, and digital rectal examination, was performed. During the rectal examination, the prostate was checked for nodules, softness, induration, or tenderness. Urine culture and antibiotic sensitivity tests were conducted to assess the bacteriological profile.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| symptomatic BPH | – | Drug: Antibiotic therapyAll patients with symptomatic BPH attending the Urology Out-Patient Department (OPD) of the study site were enrolled. Informed and written consent was obtained from all participants. Demographic data were recorded, and detailed histories were taken regarding the duration and symptoms of BPH and relevant past history. IPSS scoring was conducted. A thorough clinical examination, including general physical, systemic, and digital rectal examination, was performed. During the rectal examination, the prostate was checked for nodules, softness, induration, or tenderness. Urine culture and antibiotic sensitivity tests were conducted to assess the bacteriological profile. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with symptomatic BPH attending the Urology Out-Patient Department (OPD) of the study site were enrolled. Informed and written consent was obtained from all participants. Demographic data were recorded, and detailed histories were taken. IPSS scoring was conducted. A thorough clinical examination, including general physical, systemic, and digital rectal examination, was performed. During the rectal examination, the prostate was checked for nodules, softness, induration, or tenderness. Urine culture and antibiotic sensitivity tests were conducted to assess the bacteriological profile. The patients was started on antibiotic therapy for a week based on antibiotic susceptibility testing.
Key inclusion criteria (1 listed)
- Patients with symptomatic BPH.
Key exclusion criteria (6 listed)
- Patients with indwelling catheters
- Recent antibiotic use
- Immunocompromised states (e.g., HIV, HCV)
- Uncontrolled diabetes mellitus (Hemoglobin A1c > 7%)
- Steroid therapy
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 |
|---|---|---|
| Antibiotic therapyAlso: AntibioticsUrine culture and antibiotic sensitivity tests were conducted to assess the bacteriological profile. The patients were then prescribed antibiotics based on susceptibility testing for a duration of 1 week. | Drug | symptomatic BPH |
Primary outcome
Identification of common pathogens and Antibiotic susceptibility testing
Time frame: 4 weeks
Urine culture and antibiotic sensitivity tests were conducted to assess the bacteriological profile among symptomatic patients with BPH.
1 secondary outcome
Severity of LUTS in patients with symptomatic BPH
Time frame: 4 weeks
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 25 Jul 2024.
- Individual participant dataSharing planned: Yes. The Individual Participant Data (IPD) to be shared from this study will encompass demographic details (age, sex), clinical characteristics (severity and duration of lower urinary tract symptoms, baseline IPSS scores), microbiological findings (bacterial species isolated from urine cultures, antibiotic sensitivity patterns), treatment information (antibiotic regimen and duration), and clinical outcomes (post-treatment IPSS scores, follow-up urine culture results). This comprehensive dataset will facilitate in-depth analysis of the impact of antibiotic therapy on symptom relief and bacteriuria in patients with symptomatic Benign Prostatic Hyperplasia (BPH), thereby supporting future research and enhancing clinical management strategies.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bacteriuria in Symptomatic Benign Prostate Hyperplasia and Antibiotic Susceptibility in Symptomatic Benign Prostate Hyperplasia, run by Tribhuvan University Teaching Hospital, Institute Of Medicine. at 1 site in Nepal.
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 1 inclusion and 6 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 25 Jul 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 Nepal. 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?
Identification of common pathogens and Antibiotic susceptibility testing (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jul 2024.