Preoperative Exercise Training for Pelvic Floor in Urinary Incontinence Post RALP

NCT04037280 | Completed

• 1 other identifier: CLF19/02
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence

Keywords

Urinary; Exercise; Posology

Outcome Measures

Primary Outcomes (1)

• Pad test 48h

  Change in weighing of pad during 48 hours at 45 days

  45 days after surgery

Secondary Outcomes (2)

• Change in International Prostatic Symptoms Score (IPSS)

  Between before surgery (T0) and at 45 days after surgery (T1)

• International Consultation Incontinence Questionnaire - Short Form (ICIQ-SF)

  Between before surgery (T0) and at 45 days after surgery (T1)

Study Arms (4)

Isometric strenghtening 1

EXPERIMENTAL

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

Isometric strenghtening 2

EXPERIMENTAL

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

Functional strenghtening 1

EXPERIMENTAL

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

Functional strenghtening 2

EXPERIMENTAL

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

Interventions

Exercise OTHER

Four type of exercises will be delivered to patients. These exercises differ for posology and typology.

Functional strenghtening 1; Functional strenghtening 2; Isometric strenghtening 1; Isometric strenghtening 2

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Sites (1)

Roberto Gatti

Rozzano, Milan, 20089, Italy

Location

MeSH Terms

Conditions

Urinary Incontinence; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: After the randomization participants will be assigned to the 4 groups. The investigator will be blinded to group allocation. Moreover, the assessor will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Physiotherapy Unit

Model Details: 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.

Study Record Dates

• First Submitted: July 24, 2019
• First Posted: July 30, 2019
• Study Start: September 1, 2019
• Primary Completion: September 1, 2020
• Study Completion: December 1, 2020
• Last Updated: September 16, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)