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

C

Clinical Hospital Centre Zagreb

Status

Completed

Conditions

Urinary Incontinence

Treatments

Procedure: Profilometry

Study type

Interventional

Funder types

Other

Identifiers

NCT05247775
25062009

Details and patient eligibility

About

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.

Enrollment

43 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

43 participants in 1 patient group

Patients with prostate cancer
Experimental group
Description:
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.
Treatment:
Procedure: Profilometry

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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