Urinary IncontinenceNCT05247775
Urethral Functional Profile Length Before Radical Prostatectomy as an Early Postoperative Continence Predictor
A study testing Profilometry in people with Urinary Incontinence, run by Clinical Hospital Centre Zagreb at 1 site in Croatia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Profilometry
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteCroatia
- Study dates
- 15 Jul 2019to 7 May 2021
- Phase
- Interventional
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with localized prostate cancer
- Open Retropubic Radical Prostatectomy (ORRP) is planned as a treatment
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Urinary Incontinence
- Being tested
- Profilometry
- Keywords
- Urinary Incontinence, Radical Prostatectomy, Urethral Pressure Profile, ICIQ-UI SF, Pads
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProfilometryProcedure or surgery
Also called Urethral pressure profile measurement
Profilometry was performed in 43 patients before open retropubic radical prostatectomy.
| Study group | Role | What they receive |
|---|---|---|
| Patients with prostate cancer | Experimental | 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. Receives: Procedure: Profilometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Urethral Length as a predictor of Urinary Incontinence
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.
Measured: 24 weeks
Maximum Urethral Closure Pressure as a predictor of Urinary Incontinence
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.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start15 Jul 2019
- Primary completion1 Nov 2020
- Study completion7 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary IncontinenceStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Hospital Centre Zagreb
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mirko Bakula, Clinical Hospital Centre Zagreb
- Investigators
- Mirko Bakula, Principal investigator, Clinical Hospital Centre Zagreb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05247775
- Sponsor's protocol ID
- 25062009
- Status last verified
- Feb 2022
- First submitted
- 4 Feb 2022
- Last updated
- 21 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD that underlie results in a publication (Urethral Pressure Profilometry results, ICIQ-UI SF scoring charts and urinary pads usage) will be available upon the request to Principal Investigator
Publications
Bakula M, Hudolin T, Kolar Mitrovic H, Kastelan Z. Urethral pressure profile before radical prostatectomy as a predictor of early postoperative continence. Neurourol Urodyn. 2022 Aug;41(6):1431-1439. doi: 10.1002/nau.24978. Epub 2022 Jun 7.
PubMed 35670263
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urethral Functional Profile Length Before Radical Prostatectomy as an Early Postoperative Continence Predictor
- ClinicalTrials.gov ID
- NCT05247775
- Acronym / sponsor ID
- 25062009
- Conditions
- Urinary Incontinence
- Keywords
- Urinary Incontinence, Radical Prostatectomy, Urethral Pressure Profile, ICIQ-UI SF, Pads
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Clinical Hospital Centre ZagrebUniversity, hospital or other
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 7 May 2021 (actual)
- First posted
- 21 Feb 2022 (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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with prostate cancer | Experimental | Procedure: ProfilometryWe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients diagnosed with localized prostate cancer
- Open Retropubic Radical Prostatectomy (ORRP) is planned as a treatment
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| ProfilometryAlso: Urethral pressure profile measurementProfilometry was performed in 43 patients before open retropubic radical prostatectomy. | Procedure or surgery | Patients with prostate cancer |
Primary outcome
Functional Urethral Length as a predictor of Urinary Incontinence
Time frame: 24 weeks
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.
Maximum Urethral Closure Pressure as a predictor of Urinary Incontinence
Time frame: 24 weeks
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.
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 21 Feb 2022.
- Derived from this study: PubMed 35670263Bakula M, Hudolin T, Kolar Mitrovic H, Kastelan Z. Urethral pressure profile before radical prostatectomy as a predictor of early postoperative continence. Neurourol Urodyn. 2022 Aug;41(6):1431-1439. doi: 10.1002/nau.24978. Epub 2022 Jun 7.
- Individual participant dataSharing planned: No. IPD that underlie results in a publication (Urethral Pressure Profilometry results, ICIQ-UI SF scoring charts and urinary pads usage) will be available upon the request to Principal Investigator
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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.
Mirko Bakula principal investigator
Clinical Hospital Centre Zagreb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Profilometry in people with Urinary Incontinence, run by Clinical Hospital Centre Zagreb at 1 site in Croatia.
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 2 inclusion and 5 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 21 Feb 2022. 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 Croatia. 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?
Functional Urethral Length as a predictor of Urinary Incontinence (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05247775, which also lists 1 linked publication.
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 21 Feb 2022.