Preoperative Exercise Training for Pelvic Floor in Urinary Incontinence Post RALP

The Influence of Typology and Posology of Exercise for the Preoperative Strengthening Training of Pelvic Floor in Urinary Incontinence Post RALP

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.

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence
• Intervention / Treatment: Other: Exercise

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milan
    • Rozzano, Milan, Italy, 20089
      • Roberto Gatti

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Isometric strenghtening 1; once a day (1RI): patients in this group will have to play 20 tonic contractions of Pelvic Floor Muscle with a duration of 5 seconds each, performed in supine position), in sitting position and in standing position.	Other: Exercise; Four type of exercises will be delivered to patients. These exercises differ for posology and typology.
EXPERIMENTAL: Isometric strenghtening 2; twice a day (2RI): patients in this group will have to play the same typology of exercises in the same way just described (see above), but twice a day (in the morning and in the evening).	Other: Exercise; Four type of exercises will be delivered to patients. These exercises differ for posology and typology.
EXPERIMENTAL: Functional strenghtening 1; once a day (1RF): patients in this group will have to play 10 times the postural passage from supine position to sitting position on a bed and 10 times the postural passage from sitting position to erect position (STS), maintaining the contraction of Pelvic Floor Muscle during the execution of each functional act. In sequence, starting from erect position, they will have to play 10 trunk flexion bending their knees (as to pick up an object on the ground), maintaining the contraction of Pelvic Floor Muscle during the execution of each functional movement.	Other: Exercise; Four type of exercises will be delivered to patients. These exercises differ for posology and typology.
EXPERIMENTAL: Functional strenghtening 2; twice a day (2RF): patients in this group will have to play the same typology of exercises in the same way just described (see above), but twice a day (in the morning and in the evening).	Other: Exercise; Four type of exercises will be delivered to patients. These exercises differ for posology and typology.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pad test 48h	Change in weighing of pad during 48 hours at 45 days	45 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in International Prostatic Symptoms Score (IPSS)	IPSS evaluates the entity of urinary symptoms. It ranges from 0 (no symptoms) to 35 (severe symptoms). A higher value represents a worse outcome. The results is obtained summing the items of the scale.	Between before surgery (T0) and at 45 days after surgery (T1)
International Consultation Incontinence Questionnaire - Short Form (ICIQ-SF)	ICIQ-SF evaluates the severity of urinary incontinence during the last week. The score ranges from 0 to 21, where higher score indicates higher severity. The results is obtained summing the items of the questionnaire.	Between before surgery (T0) and at 45 days after surgery (T1)

Collaborators and Investigators

• Sponsor: Istituto Clinico Humanitas

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2019
• Primary Completion (ACTUAL): September 1, 2020
• Study Completion (ACTUAL): December 1, 2020

Study Registration Dates

• First Submitted: July 24, 2019
• First Submitted That Met QC Criteria: July 29, 2019
• First Posted (ACTUAL): July 30, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 16, 2021
• Last Update Submitted That Met QC Criteria: September 8, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Exercise; Urinary; Posology
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis
• Other Study ID Numbers: CLF19/02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No