Clinical trial NCT03714984: The Efficacy of Pre-operative Educational Pelvic Floor Intervention on Urinary Continence
Official title: The Efficacy of Pre-operative Educational Pelvic Floor Intervention on Urinary Continence in Patients Underwent Robotic Prostatectomy. A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostatectomy
Pelvic Floor Disorders
Keywords: Prostatectomy
Pelvic Floor Disorders
Robotic Surgical Procedures
rehabilitation
Lead sponsor: European Institute of Oncology
Sponsor class: OTHER
First posted: 2018-10-22
Enrollment: 120
Sex: MALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Superiority trial with 1:1 allocation ratio, randomized with two-arm parallel group
Primary purpose: SUPPORTIVE_CARE

Brief summary: Prostate cancer is the most common type of cancer between male population and urinary incontinence (UI) is the most common of long-term sequelae. Nowadays, robotic prostatectomy became the surgery standard but there is still discrepant results regards the incidence of UI and there is a lack of studies about the use of pelvic floor rehabilitation in this population. Our study aims to assesses the efficacy of preoperative educational method in urinary incontinence after robotic prostatectomy.

Detailed description: Prostate cancer is the most common type of cancer between male population, with 161,300 new cases a year in the USA and an incidence of 10% in Italy. Since many years surgery is the treatment of choice, both at an early stage and in advanced cases, but involves side effects. From the post-operative problem presents in literature, urinary incontinence (UI) is the most common of long-term sequelae and significantly affects the quality of life and the psychological aspect in the post-surgical period. The incidence of UI after prostatectomy surgery varies between 0.8% and 87% in the first 3 and 6 months and between 5% and 44.5% after 1 year. This variability depends on the UI definition and the type of measurement used, which are not homogeneous among the various studies in the literature. Evaluations that are not objective make it difficult to compare the results obtained, thus creating discrepancies.

To date, robotic prostatectomy is becoming the gold standard for its recognized greater accuracy when compared with the open surgery and laparoscopic procedure, with a reduced learning curve for operators and giving better post-surgical results. Progress technological aspects, such as the three-dimensional vision of the operative field, the macroscopic magnification and better image resolution, have made the robotic procedure a less invasive surgery with better functional outcomes. Despite these factors, UI is still present and in the majority of cases management is not completely evidence based. Moreover there is not yet a definite consensus regarding the predictive factors (age, disease stage, body weight, prostate volume and other comorbidities) in the incidence of the UI.

When patients presents UI diagnoses, the conservative intervention through the pelvic floor rehabilitation is recommended in an attempt to reduce the impact of this complication. Muscle strengthening and pelvic floor awareness after surgery are used for years in clinical practice with results widely documented in the literature, but their effectiveness in the pre-operative period, especially if after robotic surgery, has not yet been sufficiently studied. Currently, there are discrepant results mainly due to the type of rehabilitative methodology applied and the time of beginning the preoperative treatment. Our study tries to evaluate, through an objective and reproducible measurement, the efficacy of a preoperative educational method in urinary incontinence after robotic prostatectomy.

Eligibility criteria: Inclusion Criteria:

* Signed informed consent form
* Age \>= 40 \<= 70 years old
* Body mass Index \<= 27
* Indication of robotic prostate surgery
* Tumor with clinical stage T1 and T2.
* Extracapsular Extension Score \<= 3, measured with magnetic resonance before surgery.

Exclusion Criteria:

* Pathologic T3 tumor with radiotherapy indication
* Previous prostate surgery
* Previous urinary incontinence.
* Metabolic disorder
* Central or peripheral neurologic disorders
* Inability to understand informed consent or to carry out the rehabilitation protocol autonomously.

Primary outcomes:
measure: Change in self-reported urinary continence
timeFrame: 1,3,6 months and 1 year after surgery
Secondary outcomes:
measure: The degree of urinary incontinence.
timeFrame: 1,3,6 months and 1 year after surgery
measure: Quality of life instrument
timeFrame: 1,3,6 months and 1 year after surgery
measure: Assesment of the post traumatic distress using the Impact of event Scale (IES).
timeFrame: 1,3,6 months and 1 year after surgery
measure: Assesment of the individual resilience with the resilience scale for adults (RSA).
timeFrame: 1,3,6 months and 1 year after surgery
measure: Assesment of the urinary status with the International Consultation on Incontinence (ICIQ) Questionnaire.
timeFrame: 1,3,6 months and 1 year after surgery
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia
state: Lombardia
Study officials:
affiliation: European Institute of Oncology
name: Luiz Felipe Nevola Teixeira, PT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fossati N, Di Trapani E, Gandaglia G, Dell'Oglio P, Umari P, Buffi NM, Guazzoni G, Mottrie A, Gaboardi F, Montorsi F, Briganti A, Suardi N. Assessing the Impact of Surgeon Experience on Urinary Continence Recovery After Robot-Assisted Radical Prostatectomy: Results of Four High-Volume Surgeons. J Endourol. 2017 Sep;31(9):872-877. doi: 10.1089/end.2017.0085. Epub 2017 Jul 21.
citation: Centemero A, Rigatti L, Giraudo D, Lazzeri M, Lughezzani G, Zugna D, Montorsi F, Rigatti P, Guazzoni G. Preoperative pelvic floor muscle exercise for early continence after radical prostatectomy: a randomised controlled study. Eur Urol. 2010 Jun;57(6):1039-43. doi: 10.1016/j.eururo.2010.02.028. Epub 2010 Mar 1.
citation: Moore KN, Valiquette L, Chetner MP, Byrniak S, Herbison GP. Return to continence after radical retropubic prostatectomy: a randomized trial of verbal and written instructions versus therapist-directed pelvic floor muscle therapy. Urology. 2008 Dec;72(6):1280-6. doi: 10.1016/j.urology.2007.12.034. Epub 2008 Apr 2.
citation: Burgio KL, Goode PS, Urban DA, Umlauf MG, Locher JL, Bueschen A, Redden DT. Preoperative biofeedback assisted behavioral training to decrease post-prostatectomy incontinence: a randomized, controlled trial. J Urol. 2006 Jan;175(1):196-201; discussion 201. doi: 10.1016/S0022-5347(05)00047-9.