An observational study in Bacteriuria in Symptomatic Benign Prostate Hyperplasia, Antibiotic Susceptibility in Symptomatic Benign Prostate Hyperplasia and Treatment Response to Antibiotics in Symptomatic Benign Prostate Hyperplasia, sponsored by Tribhuvan University Teaching Hospital, Institute Of Medicine.. Completed at 1 site in Nepal. Open to male participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2024-07-25.
Sponsored by Tribhuvan University Teaching Hospital, Institute Of Medicine. · Observational
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.
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.
51 studies on the registry are indexed under Bacteriuria; 3 are open to participants now.
Browse Bacteriuria studies →Tribhuvan University Teaching Hospital, Institute Of Medicine. is the lead sponsor of 41 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Antibiotic therapy
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.
Also known as: Antibiotics
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.
Time frame: 4 weeks
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.
Time frame: 4 weeks
Plan to share: 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.
Supporting information: Study protocol
Time frame: Data will be made available after publication of manuscript in the journal.
Access criteria: Researchers must provide a clear scientific rationale for requesting the data. Data will be shared upon reasonable request to the corresponding author. Requests must detail the intended use of the data and ensure it aligns with the ethical guidelines, ensuring patient confidentiality.
No publications or documents are linked to this record.
Ran from Sep 2020 to primary completion in Jun 2021, 9 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Tribhuvan University Teaching Hospital, Institute Of Medicine.