Clinical trial NCT04037280: Preoperative Exercise Training for Pelvic Floor in Urinary Incontinence Post RALP
Official title: The Influence of Typology and Posology of Exercise for the Preoperative Strengthening Training of Pelvic Floor in Urinary Incontinence Post RALP
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Keywords: Urinary
Exercise
Posology
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2019-07-30
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 120 subjects on the list for RALP surgery will be recruited and randomized into 4 groups. Subjects will be evaluated during the preoperative session (T0) and about 45-55 days before the surgery (T1). The initial assessment shall provide for the compilation of two self-assessment questionnaires concerning urinary symptoms: IPSS (International Prostatic Symptoms Score) and ICIQ-SF (International Consultation on Incontinence Questionnaire- Short Form). Furthermore, the impact of quality of life of patient (index of quality of life 0-6) will be evaluated, in order to give a numerical indicator to the patient's perception about its condition.

The same questionnaires will be given by a physiotherapist during follow-up session (T1) before 45-55 days post-surgery, when the amount of urinary incontinence through PAD test 48h will be evaluated, that provides for the weighing of used pad by patient during 48 hours before the session.
Primary purpose: TREATMENT

Brief summary: The aim of the study is to investigate how posology and typology of preoperative strengthening training of Pelvic Floor Muscle before RALP surgery can affect the postoperative urinary incontinence. 120 subjects undergoing RALP (Robotic-assisted laparoscopic prostatectomy) will be recruited. The amount of urinary leakage for 48h after 45-55 days post-surgery (Pad Test 48h) will be assessed. Urinary symptoms (IPSS and ICIQ-SF) and their impact on quality of life (index of quality of life 0-6) will be also evaluated. Data will be collected preoperatively (about 30-40 days before surgery) and at 45-55- days after surgery.

Detailed description: The male urinary incontinence is one of the possible complications following radical prostatectomy surgery. It represents one of the main problems with great impact on quality of life, physical activity or social well being.

Previous studies define strengthening exercises for the pelvic floor as the most effective conservative approach for postoperative continence recovery. However, the effect of a preoperative exercises training is still controversial.

To date, studies evaluating the influence of a preoperative rehabilitation program in postoperative urinary incontinence to varying of exercises posology (number of daily repetitions) and of the exercises typology (isometric exercises VS functional exercises) have still not been published.

The aim of this clinical study is to investigate possible changes concerning the urinary incontinence in subjects undergoing a robotic-assisted laparoscopic prostatectomy, to varying of posology and typology of preoperative exercises.

120 subjects undergoing a RALP (Robotic-assisted laparoscopic prostatectomy) will be recruited. The inclusion criteria will be: RALP surgery planned after approximately 30-40 days from the preoperative session, objectivity of Pelvic Floor Muscle recruitment and contraction at manual perineal testing during preoperative session. Subjects with urinary incontinence before surgery, patients receiving radiotherapy treatment before surgery or patients who have had previous urogenital surgery shall be excluded from the study. Moreover, subjects with cognitive and/or psychiatric deficits and subjects with concurrent neurological conditions, internal conditions or disorders of the musculoskeletal system, which may affect the functional or motor recovery, will be excluded from the study.

The recruited patient will be randomized and stratified by age in 4 groups according to exercise posology and typology and 4 different exercise protocols will be administered according Group of intervention.

The primary outcome is to quantify the amount of the urinary leakage for 48h after 45-55 days post-surgery (Pad Test 48h). The secondary outcome is to evaluate urinary symptoms (IPSS and ICIQ-SF) and their impact on quality of life (index of quality of life 0-6), through self-assessment questionnaires compiled during preoperative session (about 30-40 days before surgery) and after 45-55- days (follow-up). At the end of the data collection, a verification of normality and homogeneity of demographic variables and of outcome measures will be proceeded. Any differences between groups will be investigated through ANOVA test for mixed models with possible post-hoc analysis.

Eligibility criteria: Inclusion Criteria:

* On the list for RALP (Robotic-assisted laparoscopic prostatectomy) surgery expected 30-40 days before preoperative session
* Objectivity of Pelvic Floor Muscle recruitment and contraction at manual perineal testing during pre-operative session

Exclusion Criteria:

* Incontinence before surgery
* Radiotherapy treatment before surgery
* Previous urogenital surgery
* Simultaneous presence of neurological disorders, internal conditions or disorders of the musculoskeletal system that may affect the functional or motor recovery.

Primary outcomes:
measure: Pad test 48h
timeFrame: 45 days after surgery
Secondary outcomes:
measure: Change in International Prostatic Symptoms Score (IPSS)
timeFrame: Between before surgery (T0) and at 45 days after surgery (T1)
measure: International Consultation Incontinence Questionnaire - Short Form (ICIQ-SF)
timeFrame: Between before surgery (T0) and at 45 days after surgery (T1)
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Roberto Gatti
state: Milan
Study officials:
References: