Study Results
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Basic Information
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COMPLETED
11 participants
OBSERVATIONAL
2019-06-04
2022-07-31
Brief Summary
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Detailed Description
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Group 1: Patients with BPH and significant improvement in the storage symptoms following BOO procedures.
Group 2: Patients with BPH who have persistent storage symptoms following BOO procedures.
Group 3 (CONTROL GROUP): Men without LUTS who are planning to undergo radical prostatectomy.
Each participant will provide a detailed history, undergo a complete physical examination and will have the following assessments: IPSS, IPSS Quality of life, Incontinence Severity Index (ISI), Patient Global impression of severity (PGI-S) and improvement (PGI-I)19, 20, International Index of Erectile Function (IIEF-5), MRI Safety Screening Questionnaire. A post void residual volume will be measured and a urine sample will be obtained for urinalysis (patients and controls). A two-day bladder diary will also be obtained from the participants. Participants in group 1 and 2 will undergo a clinical urodynamic study within a year prior to the neuroimaging scan. All participants will be followed up at one, three and six months after the BOO procedures (Transurethral resection/ablation of prostate and simple prostatectomy) and radical prostatectomy in the control group. On each visit, the investigators will gather the following data: Uroflow and PVR assessment, bladder diary, and all questionnaires will be repeated in all patients at one, three, and six months. Participants with persistent storage LUTS at six months will have a repeat UDS to ensure BOO is resolved. Group 1 and 2 will undergo simultaneous fMRI/UDS scanning twice during this study: First before BOO procedures and at the second one at six months. The control group will undergo baseline fMRI/UDS.
Investigators' established platform for simultaneous urodynamic study and functional MRI scanning will allow investigators to detect structural changes during the micturition cycle. Providing 3D structural images and functional images to have a better understanding of the brain effect on LUTS. By correlating the bold signal changes, structural markers and participant's clinical data, investigators will provide scientific rationale for subsequent studies in the field of neurourology.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group 1
Patients with BPH and significant improvement in storage symptoms after BOO procedures
Simultaneous functional MRI and urodynamic studies
Double lumen 7 Fr MRI-compatible catheters will be placed in the bladder and rectum. A Phillips Ingenia 3.0T full body MRI scanner with standard 12 channel head coil will be used. Instructions to communicate using right hand signals representing "full urge" and "voiding or attempt of voiding" will be given. Signs will be shown to the patient when filling of the bladder is begun and when filling is stopped. Also, in order to keep our noise-to-signal ratio low, all stimulators including any extra visual stimuli and the UDS machine will be removed from the MRI scanner room. The filling and voiding cycle will be repeated up to 4 times in each patient. Bladder will be aspirated after each voiding. This algorithm will be performed before, and, 3 and 6 months following BOO procedure.
Questionnaires
Each patient will provide a detailed history and undergo a complete physical examination. Each patient will have the following assessments: IPSS and Incontinence Severity Index (ISI), Patient Global impression of severity (PGI-S) and improvement (PGI-I), International Index of Erectile Function (IIEF-5), MRI Safety Screening Questionnaire.
Post Void Residual (PVR), Uroflow and Bladder Diary
Follow-up assessments: Uroflow and PVR assessment, bladder diary, and all questionnaires will be repeated in all patients at one, three, and six months.
Urinalysis
Urine sample
Group 2
Patients with BPH who have persistent storage symptoms after BOO procedures
Simultaneous functional MRI and urodynamic studies
Double lumen 7 Fr MRI-compatible catheters will be placed in the bladder and rectum. A Phillips Ingenia 3.0T full body MRI scanner with standard 12 channel head coil will be used. Instructions to communicate using right hand signals representing "full urge" and "voiding or attempt of voiding" will be given. Signs will be shown to the patient when filling of the bladder is begun and when filling is stopped. Also, in order to keep our noise-to-signal ratio low, all stimulators including any extra visual stimuli and the UDS machine will be removed from the MRI scanner room. The filling and voiding cycle will be repeated up to 4 times in each patient. Bladder will be aspirated after each voiding. This algorithm will be performed before, and, 3 and 6 months following BOO procedure.
Questionnaires
Each patient will provide a detailed history and undergo a complete physical examination. Each patient will have the following assessments: IPSS and Incontinence Severity Index (ISI), Patient Global impression of severity (PGI-S) and improvement (PGI-I), International Index of Erectile Function (IIEF-5), MRI Safety Screening Questionnaire.
Post Void Residual (PVR), Uroflow and Bladder Diary
Follow-up assessments: Uroflow and PVR assessment, bladder diary, and all questionnaires will be repeated in all patients at one, three, and six months.
Urinalysis
Urine sample
Group 3 (Control group)
Men without LUTS who are planning to undergo radical prostatectomy
Simultaneous functional MRI and urodynamic studies
Double lumen 7 Fr MRI-compatible catheters will be placed in the bladder and rectum. A Phillips Ingenia 3.0T full body MRI scanner with standard 12 channel head coil will be used. Instructions to communicate using right hand signals representing "full urge" and "voiding or attempt of voiding" will be given. Signs will be shown to the patient when filling of the bladder is begun and when filling is stopped. Also, in order to keep our noise-to-signal ratio low, all stimulators including any extra visual stimuli and the UDS machine will be removed from the MRI scanner room. The filling and voiding cycle will be repeated up to 4 times in each patient. Bladder will be aspirated after each voiding. This algorithm will be performed before, and, 3 and 6 months following BOO procedure.
Questionnaires
Each patient will provide a detailed history and undergo a complete physical examination. Each patient will have the following assessments: IPSS and Incontinence Severity Index (ISI), Patient Global impression of severity (PGI-S) and improvement (PGI-I), International Index of Erectile Function (IIEF-5), MRI Safety Screening Questionnaire.
Post Void Residual (PVR), Uroflow and Bladder Diary
Follow-up assessments: Uroflow and PVR assessment, bladder diary, and all questionnaires will be repeated in all patients at one, three, and six months.
Urinalysis
Urine sample
Interventions
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Simultaneous functional MRI and urodynamic studies
Double lumen 7 Fr MRI-compatible catheters will be placed in the bladder and rectum. A Phillips Ingenia 3.0T full body MRI scanner with standard 12 channel head coil will be used. Instructions to communicate using right hand signals representing "full urge" and "voiding or attempt of voiding" will be given. Signs will be shown to the patient when filling of the bladder is begun and when filling is stopped. Also, in order to keep our noise-to-signal ratio low, all stimulators including any extra visual stimuli and the UDS machine will be removed from the MRI scanner room. The filling and voiding cycle will be repeated up to 4 times in each patient. Bladder will be aspirated after each voiding. This algorithm will be performed before, and, 3 and 6 months following BOO procedure.
Questionnaires
Each patient will provide a detailed history and undergo a complete physical examination. Each patient will have the following assessments: IPSS and Incontinence Severity Index (ISI), Patient Global impression of severity (PGI-S) and improvement (PGI-I), International Index of Erectile Function (IIEF-5), MRI Safety Screening Questionnaire.
Post Void Residual (PVR), Uroflow and Bladder Diary
Follow-up assessments: Uroflow and PVR assessment, bladder diary, and all questionnaires will be repeated in all patients at one, three, and six months.
Urinalysis
Urine sample
Eligibility Criteria
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Inclusion Criteria
* IPSS (International prostate symptom score lower than 12)
* Nocturia equal or less than 2 on a two day bladder diary
* Group 1 (n=18) Men older than 45 with improved LUTS after 6 months of a BOO procedure and IPSS less than 12
* Improvement in IPSS in at least 3 points for storage symptoms
* Nocturia equal or less than 2 on a two day bladder diary
* Group 2 (n=9) Men older than 45 with persistent LUTS at six months post BOO procedure
* IPSS higher than 8
* Nocturia more than 2
* Delta change in IPSS score less than negative 3 points
Exclusion Criteria
* Neurogenic bladder
* Urethral stricture
* Prior BOO procedures
* History of bladder cancer within 5 years
* History of treatment for prostate cancer other than active surveillance
* Intradetrusor injection of BTX-A within 9 months prior to screening for any urological condition
45 Years
90 Years
MALE
No
Sponsors
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The Methodist Hospital Research Institute
OTHER
Responsible Party
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Rose Khavari, M.D.
Principal Investigator, Houston Methodist Hospital Urologist & Research Director
Principal Investigators
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Rose Khavari, MD
Role: PRINCIPAL_INVESTIGATOR
The Methodist Hospital Research Institute
Locations
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Houston Methodist Hospital
Houston, Texas, United States
Countries
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Other Identifiers
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Pro00020695
Identifier Type: -
Identifier Source: org_study_id
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