Urinary IncontinenceNCT04037280
Preoperative Exercise Training for Pelvic Floor in Urinary Incontinence Post RALP
A study testing Exercise in people with Urinary Incontinence, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2019to 1 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Urinary Incontinence
- Being tested
- Exercise
- Keywords
- Urinary, Exercise, Posology
- Medical subject headings
- Urinary Incontinence, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Four type of exercises will be delivered to patients. These exercises differ for posology and typology.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: 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. Receives: 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). Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pad test 48h
Change in weighing of pad during 48 hours at 45 days
Measured: 45 days after surgery
Secondary outcomes (2)
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.
Measured: 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.
Measured: Between before surgery (T0) and at 45 days after surgery (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study start1 Sep 2019
- Primary completion1 Sep 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Tedeschi, Istituto Clinico Humanitas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04037280
- Sponsor's protocol ID
- CLF19/02
- Status last verified
- Sep 2021
- First submitted
- 24 Jul 2019
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Typology and Posology of Exercise for the Preoperative Strengthening Training of Pelvic Floor in Urinary Incontinence Post RALP
- ClinicalTrials.gov ID
- NCT04037280
- Acronym / sponsor ID
- CLF19/02
- Conditions
- Urinary Incontinence
- Keywords
- Urinary, Exercise, Posology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 30 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Isometric strenghtening 1 | Experimental | Other: Exerciseonce 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. |
| Isometric strenghtening 2 | Experimental | Other: Exercisetwice 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). |
| Functional strenghtening 1 | Experimental | Other: Exerciseonce 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. |
| Functional strenghtening 2 | Experimental | Other: Exercisetwice 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). |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseFour type of exercises will be delivered to patients. These exercises differ for posology and typology. | Other | Functional strenghtening 1, Functional strenghtening 2, Isometric strenghtening 1, Isometric strenghtening 2 |
Primary outcome
Pad test 48h
Time frame: 45 days after surgery
Change in weighing of pad during 48 hours at 45 days
2 secondary outcomes
Change in International Prostatic Symptoms Score (IPSS)
Time frame: Between before surgery (T0) and at 45 days after surgery (T1)
International Consultation Incontinence Questionnaire - Short Form (ICIQ-SF)
Time frame: Between before surgery (T0) and at 45 days after surgery (T1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Individual participant dataSharing planned: No. There is no plan
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Urinary Incontinence, run by Istituto Clinico Humanitas at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pad test 48h (time frame: 45 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2021; AzTrials last refreshed its copy on 3 Nov 2026.