Ultrassonografia IPP para Prever a Resposta à Terapia Médica em LUTS/BPH
Papel da Estimativa por Ultrassom da Protrusão Prostática Intra-Vesical na Previsão da Resposta à Terapia Médica em Pacientes com Sintomas do Trato Urinário Inferior Secundários à Hiperplasia Prostática Benigna
This prospective cohort study evaluated whether transabdominal ultrasound measurement of intravesical prostatic protrusion predicts symptom severity and response to medical therapy in men aged 50 years or older with lower urinary tract symptoms secondary to benign prostatic hyperplasia. At baseline, participants underwent clinical evaluation, laboratory assessment including prostate-specific antigen, symptom scoring using the International Prostate Symptom Score and quality of life index, uroflowmetry, and transabdominal ultrasonography to measure prostate volume, bladder parameters, post-void residual urine, detrusor wall thickness, and intravesical prostatic protrusion. Participants were grouped by intravesical prostatic protrusion grade (less than 5 millimetres, 5 to 10 millimetres, and greater than 10 millimetres) and were followed for six months with reassessments at three and six months to evaluate response to medical therapy and identify patients who required escalation of treatment or surgical intervention.
Visão geral do estudo
Status
Status
Condições
Condições
Intervenção / Tratamento
Intervenção / Tratamento
Tipo de estudo
Tipo de estudo
Inscrição (Real)
Inscrição
Contactos e Locais
Locais de estudo
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-
Cairo Governorate
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Cairo, Cairo Governorate, Egito, 11511
- Ain Shams University Hospitals
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-
Critérios de participação
Critérios de elegibilidade
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Men aged 50 years or older with moderate to severe lower urinary tract symptoms secondary to benign prostatic hyperplasia attending urology outpatient services at Ain Shams University Hospitals.
Descrição
Inclusion Criteria:
- Male participants aged 50 years or older.
- Lower urinary tract symptoms secondary to benign prostatic hyperplasia.
- Moderate to severe symptoms with International Prostate Symptom Score 15 to 35.
- Prostate volume 30 to 100 millilitres.
- Maximum urinary flow rate less than 15 millilitres per second.
- No hydronephrosis due to bladder outlet obstruction.
- Normal prostate-specific antigen or normal free-to-total prostate-specific antigen ratio.
Exclusion Criteria:
- History of prostate, bladder, or lower urinary tract surgery.
- Neurological disease affecting lower urinary tract function.
- Active urinary tract infection and/or symptomatic urinary tract stones.
- Post-void residual urine volume greater than 200 millilitres.
- Urethral stricture.
- Prostate cancer or bladder cancer.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: COHORT
- Perspectivas de Tempo: PROSPECTIVE
Número de grupos/coortes
Coortes e Intervenções
Grupo / CoorteGrupo / Coorte |
Intervenção / TratamentoIntervenção / Tratamento |
|---|---|
|
IPP Grade I (<5 mm)
Participants with lower urinary tract symptoms secondary to benign prostatic hyperplasia and intravesical prostatic protrusion less than 5 millimetres measured by transabdominal ultrasonography at bladder volume 100-200 millilitres. Participants received medical therapy as prescribed by the treating urologist and were followed for 6 months with assessments at baseline, 3 months, and 6 months including International Prostate Symptom Score/quality of life, uroflowmetry, and ultrasound parameters. |
Transabdominal ultrasonography; TAUS; Ultrasound IPP measurement Intervention Description: Intravesical prostatic protrusion was measured using transabdominal ultrasonography in the midsagittal plane at a bladder volume of approximately 100-200 millilitres. The measurement was defined as the distance (millimetres) from the bladder neck to the tip of the protruding prostatic tissue, and participants were categorized into Grade I (<5 millimetres), Grade II (5-10 millimetres), or Grade III (>10 millimetres). Ultrasound assessment was performed at baseline and during follow-up per protocol. Participants received an alpha-adrenergic blocker as part of standard medical therapy for benign prostatic hyperplasia-related lower urinary tract symptoms. The specific agent, dose, dosing frequency, and duration were prescribed by the treating urologist and recorded throughout follow-up. Participants received a 5-alpha reductase inhibitor as part of standard medical therapy for benign prostatic hyperplasia-related lower urinary tract symptoms. The specific agent, dose, dosing frequency, and duration were prescribed by the treating urologist and recorded throughout follow-up. |
|
IPP Grade II (5-10 mm)
Participants with lower urinary tract symptoms secondary to benign prostatic hyperplasia and intravesical prostatic protrusion 5 to 10 millimetres measured by transabdominal ultrasonography at bladder volume 100-200 millilitres. Participants received medical therapy as prescribed by the treating urologist and were followed for 6 months with assessments at baseline, 3 months, and 6 months including International Prostate Symptom Score/quality of life, uroflowmetry, and ultrasound parameters. |
Transabdominal ultrasonography; TAUS; Ultrasound IPP measurement Intervention Description: Intravesical prostatic protrusion was measured using transabdominal ultrasonography in the midsagittal plane at a bladder volume of approximately 100-200 millilitres. The measurement was defined as the distance (millimetres) from the bladder neck to the tip of the protruding prostatic tissue, and participants were categorized into Grade I (<5 millimetres), Grade II (5-10 millimetres), or Grade III (>10 millimetres). Ultrasound assessment was performed at baseline and during follow-up per protocol. Participants received an alpha-adrenergic blocker as part of standard medical therapy for benign prostatic hyperplasia-related lower urinary tract symptoms. The specific agent, dose, dosing frequency, and duration were prescribed by the treating urologist and recorded throughout follow-up. Participants received a 5-alpha reductase inhibitor as part of standard medical therapy for benign prostatic hyperplasia-related lower urinary tract symptoms. The specific agent, dose, dosing frequency, and duration were prescribed by the treating urologist and recorded throughout follow-up. |
|
IPP Grade III (>10 mm)
Participants with lower urinary tract symptoms secondary to benign prostatic hyperplasia and intravesical prostatic protrusion greater than 10 millimetres measured by transabdominal ultrasonography at bladder volume 100-200 millilitres. Participants received medical therapy as prescribed by the treating urologist and were followed for 6 months with assessments at baseline, 3 months, and 6 months including International Prostate Symptom Score/quality of life, uroflowmetry, and ultrasound parameters. |
Transabdominal ultrasonography; TAUS; Ultrasound IPP measurement Intervention Description: Intravesical prostatic protrusion was measured using transabdominal ultrasonography in the midsagittal plane at a bladder volume of approximately 100-200 millilitres. The measurement was defined as the distance (millimetres) from the bladder neck to the tip of the protruding prostatic tissue, and participants were categorized into Grade I (<5 millimetres), Grade II (5-10 millimetres), or Grade III (>10 millimetres). Ultrasound assessment was performed at baseline and during follow-up per protocol. Participants received an alpha-adrenergic blocker as part of standard medical therapy for benign prostatic hyperplasia-related lower urinary tract symptoms. The specific agent, dose, dosing frequency, and duration were prescribed by the treating urologist and recorded throughout follow-up. Participants received a 5-alpha reductase inhibitor as part of standard medical therapy for benign prostatic hyperplasia-related lower urinary tract symptoms. The specific agent, dose, dosing frequency, and duration were prescribed by the treating urologist and recorded throughout follow-up. |
O que o estudo está medindo?
Medidas de resultados primários
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in International Prostate Symptom Score
Prazo: Baseline and 6 months
|
The International Prostate Symptom Score was used to quantify lower urinary tract symptom severity. The outcome was the change in total score between baseline (pre-treatment) and the 6-month follow-up visit. The International Prostate Symptom Score (IPSS) is a seven-item questionnaire assessing lower urinary tract symptom severity. Each item is scored from 0 to 5, giving a total score ranging from 0 to 35, with higher scores indicating more severe symptoms. The outcome was the change in total IPSS from baseline to the 6-month follow-up visit. |
Baseline and 6 months
|
Medidas de resultados secundários
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in quality of life score
Prazo: Baseline and 6 months
|
Change in the quality of life index associated with the Intenational Prostate Symptom Score between baseline and 6 months. The International Prostate Symptom Score quality-of-life (IPSS-QoL) question is a single item scored from 0 to 6, where 0 indicates the best quality of life and 6 indicates the worst quality of life related to urinary symptoms. Higher scores indicate worse quality of life. The outcome was the change in IPSS-QoL score from baseline to the 6-month follow-up visit. |
Baseline and 6 months
|
|
Change in maximum urinary flow rate
Prazo: Baseline and 6 months
|
Change in maximum urinary flow rate measured by uroflowmetry between baseline and 6 months. |
Baseline and 6 months
|
|
Change in post-void residual urine volume
Prazo: Baseline and 6 months
|
Change in post-void residual urine volume measured by transabdominal ultrasonography between baseline and 6 months. |
Baseline and 6 months
|
|
Change in detrusor wall thickness
Prazo: Baseline and 6 months
|
Change in detrusor wall thickness measured by transabdominal ultrasonography between baseline and 6 months. |
Baseline and 6 months
|
|
Need for escalation of management during follow-up
Prazo: Up to 6 months
|
Proportion of participants who required escalation of management during follow-up (for example, change or intensification of medical therapy or referral for surgical management) due to persistent symptoms or poor objective improvement. |
Up to 6 months
|
Colaboradores e Investigadores
Patrocinador
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Início do estudo
Conclusão Primária (Real)
Conclusão Primária
Conclusão do estudo (Real)
Conclusão do estudo
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Primeira postagem
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última Atualização Postada
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças urogenitais
- Doenças Genitais
- Doenças Genitais, Masculino
- Doenças prostáticas
- Doenças Urogenitais Masculinas
- Doenças Urológicas
- Doenças Urogenitais Femininas
- Doenças urogenitais femininas e complicações na gravidez
- Manifestações Urológicas
- Doenças da Bexiga Urinária
- Doenças uretrais
- Obstrução Uretral
- Condições Patológicas, Sinais e Sintomas
- Sinais e sintomas
- Hiperplasia prostática
- Sintomas do Trato Urinário Inferior
- Obstrução do Pescoço da Bexiga Urinária
- Efeitos fisiológicos das drogas
- Mecanismos Moleculares de Ação Farmacológica
- Hormônios, substitutos hormonais e antagonistas hormonais
- Inibidores Enzimáticos
- Agentes Neurotransmissores
- Inibidores da síntese de esteróides
- Antagonistas hormonais
- Agentes Adrenérgicos
- Antagonistas Adrenérgicos
- Ações farmacológicas
- Ações e usos químicos
- Alfa-antagonistas adrenérgicos
- Inibidores da 5-alfa Redutase
Outros números de identificação do estudo
Outros números de identificação do estudo
- FMASU MS 848/2025
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
De-identified individual participant data collected during the study will be shared, including baseline and follow-up measurements (International Prostate Symptom Score and quality of life index, uroflowmetry parameters, transabdominal ultrasound parameters including intravesical prostatic protrusion, prostate volume, post-void residual urine, and detrusor wall thickness), along with a data dictionary. Direct identifiers will be removed and data will be coded prior to sharing.
Prazo de Compartilhamento de IPD
De-identified data will be available beginning 6 months after study completion and will remain available for 5 years.
Critérios de acesso de compartilhamento IPD
Data will be shared with qualified researchers upon reasonable request and after review and approval by the study investigators and the institutional administration. Requesters must submit a proposal outlining objectives and planned analyses and must sign a data use agreement that prohibits re-identification and limits use to the approved purpose.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CIF
- ANALYTIC_CODE
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