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Urethral Functional Profile Length Before Radical Prostatectomy as an Early Postoperative Continence Predictor

Urethral Functional Profile Length Before Radical Prostatectomy as an Early Postoperative Continence Predictor

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05247775
Enrollment
43
Registered
2022-02-21
Start date
2019-07-15
Completion date
2021-05-07
Last updated
2022-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Incontinence

Keywords

Urinary Incontinence, Radical Prostatectomy, Urethral Pressure Profile, ICIQ-UI SF, Pads

Brief 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. 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.

Interventions

PROCEDUREProfilometry

Profilometry was performed in 43 patients before open retropubic radical prostatectomy.

Sponsors

Clinical Hospital Centre Zagreb
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Patients diagnosed with localized prostate cancer 2. Open Retropubic Radical Prostatectomy (ORRP) is planned as a treatment

Exclusion criteria

1. Incontinent patients prior to ORRP 2. Previous surgery in the area of the prostatic urethra 3. Previous procedures that can damage the innervation of the pelvis 4. Radiotherapy performed in the pelvic area prior to ORRP 5. Adjuvant radiotherapy in the first postoperative year

Design outcomes

Primary

MeasureTime frameDescription
Functional Urethral Length as a predictor of Urinary Incontinence24 weeksFunctional 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 Incontinence24 weeksMaximum 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.

Countries

Croatia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026