- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05247775
Urethral Functional Profile Length Before Radical Prostatectomy as an Early Postoperative Continence Predictor
Urinary incontinence (UI) is one of the most common complications of radical prostatectomy (RP). Impaired urethral sphincter function is generally considered to be the most important contributing factor of UI however, the mechanism of onset and recovery of urinary continence has not been fully elucidated. In this research, the urodynamic method of Urethral Pressure Profile (UPP) was used to evaluate Functional Urethral Length (FUL) and Maximal Urethral Closure Pressure (MUCP) and correlate with the postprostatectomy continence recovery. Objective of this research is to evaluate preoperative FUL and MUCP as an early continence recovery predictors after open retropubic RP (ORRP).
The research was conducted at the Department of Urology of the University Hospital Centre Zagreb on a group of 43 patients in the period from July 15th , 2019 to May 07th , 2021.The severity of UI and bothersome were assessed using fully validated International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF) and number of pads used in 24h. Patients were interviewed about the use of urinary pads and asked to fill out the ICIQ-UI SF before and 2, 8, 16 and 24 weeks after RP.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Zagreb, Croatia, 10000
- UHC Zagreb
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients diagnosed with localized prostate cancer
- Open Retropubic Radical Prostatectomy (ORRP) is planned as a treatment
Exclusion Criteria:
- Incontinent patients prior to ORRP
- Previous surgery in the area of the prostatic urethra
- Previous procedures that can damage the innervation of the pelvis
- Radiotherapy performed in the pelvic area prior to ORRP
- Adjuvant radiotherapy in the first postoperative year
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Patients with prostate cancer
We performed urethral pressure profilometry prior to open retropubic radical prostatectomy (ORRP).
Patients were interviewed about the urinary incontinence by the usage of pads and International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) prior to ORRP and at 2, 8, 16 and 24 weeks after ORRP.
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Profilometry was performed in 43 patients before open retropubic radical prostatectomy.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Functional Urethral Length as a predictor of Urinary Incontinence
Time Frame: 24 weeks
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Functional Urethral Length (FUL) is measured using Urethral Presssure Profilometry and expressed in mm.
The severity of urinary incontinence and bothersome were assessed using fully validated International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF) and number of pads used in 24h.
Patients were interviewed about the use of urinary pads and asked to fill out the ICIQ-UI SF before and 2, 8, 16 and 24 weeks after radical prostatectomy.
ICIQ-UI SF score ranges: min 0, max 21 (higher score indicating greater severity of symptoms).
Cut-off for positive UI, in this research, was 6. Cut-off for positive UI by number of pads used per day was 2.
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24 weeks
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Maximum Urethral Closure Pressure as a predictor of Urinary Incontinence
Time Frame: 24 weeks
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Maximum Urethral Closure Pressure (MUCP) is measured using Urethral Presssure Profilometry and expressed cmH2O.
The severity of urinary incontinence and bothersome were assessed using fully validated International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF) and number of pads used in 24h.
Patients were interviewed about the use of urinary pads and asked to fill out the ICIQ-UI SF before and 2, 8, 16 and 24 weeks after radical prostatectomy.
ICIQ-UI SF score ranges: min 0, max 21 (higher score indicating greater severity of symptoms).
Cut-off for positive UI, in this research, was 6. Cut-off for positive UI by number of pads used per day was 2.
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24 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mirko Bakula, Clinical Hospital Centre Zagreb
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25062009
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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