Preoperative Exercise Training for Pelvic Floor in Urinary Incontinence Post RALP
Condition: Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis
Study type: Interventional

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.
    

Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): Four type of exercises will be delivered to patients. These exercises differ for posology and typology.
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Urinary; Exercise; Posology