Stress Urinary IncontinenceNCT05954234
Combining Pelvic Floor Rehabilitation With Postural Re-education in Women With Stress Urinary Incontinence and Chronic Low Back Pain: a Preliminary Study.
A study testing Postural re-education, Spinal mobilization and Perineal Exercises in people with Stress Urinary Incontinence and Low Back Pain, run by I.R.C.C.S. Fondazione Santa Lucia at 1 site in Italy.
Trial summary
Stress Urinary incontinence (SUI) is a common health condition in female population. Although its prevalence increases with the age, women of all ages could be affected. Several epidemiological studies have shown an association of SUI with Low Back Pain (LBP) demonstrating, moreover, that the presence of one condition… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Stress Urinary Incontinence, Low Back Pain
- What is being tested?
- Postural re-education, Spinal mobilization and Perineal Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 20 Apr 2021to 8 Aug 2022
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- woman aged from 18 to 75 years;
- diagnosis of Stress Urinary Incontinence associated with non-specific chronic Low Back Pain
Who cannot join
- severe pelvic organs prolapse (>second stage following the International Continence Society (ICS) classification);
- pregnancy;
- perineal denervation;
- inverted perineal command;
- presence of pelvic pain;
- fecal incontinence;
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- vaginal infections;
- associated pathologies involving the Central Nervous System (CNS);
- psychotic disorders
Trial locations and contacts
1 site in 1 country.
About this study
Stress Urinary incontinence (SUI) is a common health condition in female population. Although its prevalence increases with the age, women of all ages could be affected. Several epidemiological studies have shown an association of SUI with Low Back Pain (LBP) demonstrating, moreover, that the presence of one condition may predispose the patient to the onset of the other. Concerning the LBP, the clinical practice guidelines provided recommendations for physical rehabilitative treatment. Different techniques and physical exercises have been developed and it is difficult at the date to affirm the superiority of one approach as compared to another. Moreover, the crucial role plays by the pelvic floor muscles (PFM) both as an integral part of trunk and lumbo-pelvic stability and in maintenance of urinary continence, lead the pelvic floor muscles disfunction to be associated both with SUI and LBP, making the PFM rehabilitation a useful approach in both the conditions. In this rehabilitative context the present study aims to verify the effectiveness of a global physical approach based on postural re-education combined to the pelvic floor rehabilitation in women with diagnosis of stress urinary incontinence associated with non-specific chronic low back pain.
- Conditions
- Stress Urinary Incontinence, Low Back Pain
- Being tested
- Postural re-education, Spinal mobilization, Perineal Exercises
- Medical subject headings
- Urinary Incontinence, Stress, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postural re-educationOther
Each session of the experimental approach will be composed of 40 minutes of postural exercise. Participants will be asked to maintain two different postures to stretch both the anterior and posterior muscle chains. The first posture will consist of lying on the back maintaining the extension of the legs to release the respiratory diaphragm and stretch the anterior muscle chain. For the second posture, participants wiil be asked to lie on their back with their legs flexed to stretch the posterior chai. For each posture, the physical therapist will use verbal commands and manual contact to maintain alignment and make the necessary postural corrections to optimize the stretching and discourage compensatory movements.
10 sessions of the allocated intervention will be performed and organized in 2 times a week for 5 weeks.
Spinal mobilizationOther
This approach will consist of 40 minutes of thoracolumbar spine mobilization. Two different mobilizations will be carried out. In the first one the patient will be in sitting position with both legs out of the bed and a mobilization in antero-posterior direction will be provide by the physiotherapist; the second one will consist in rotational mobilisation provide with the patient in lateral decubitus position.
10 sessions of the allocated intervention will be performed and organized in 2 times a week for 5 weeks.
Perineal ExercisesOther
Perineal Exercises will be performed in both the allocated approach. The protocol will consist in 10 minutes of perineal contraction and relaxation and 10 minutes of stretch-reflex for a total of 20 minutes of perineal exercises.10 sessions of the allocated intervention will be performed and organized in 2 times a week for 5 weeks.
| Study group | Role | What they receive |
|---|---|---|
| pelvic floor rehabilitation and postural re-education | Active comparator | Not described Receives: Other: Postural re-education; Other: Perineal Exercises |
| pelvic floor rehabilitation and spinal mobilization | Active comparator | Not described Receives: Other: Spinal mobilization; Other: Perineal Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Consultation on Incontinence Questionnaire-Urinary Short Form (ICIQ-UI SF)
Change of International Consultation on Incontinence Questionnaire-Urinary Short Form (ICIQ-UI SF) from baseline, at 10 sessions of treatment, and at 30 days after the end of the training. The ICIQ-UI SF evaluate the frequency, severity and impact on quality of life (QoL) of urinary incontinence. It is ranging from 0 to 21 where 0 is the minimum and 21 the maximum. An higer score indicates greater impairment from incontinence.
Measured: Baseline, after after 5 weeks of treatment , and 1 month after the end of training
Secondary outcomes (2)
Pain Visual Analogue Scale (VAS)
Change of Pain Visual Analogue Scale (VAS) from baseline, at 10 sessions of treatment, and at 30 days after the end of the training. The VAS consisted in a straight horizontal line of fixed length (100 mm).
Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
Measured: Baseline, after 5 weeks of treatment , and 1 month after the end of training
Modified Oxford Scale (MOS)
Change of Modified Oxford Scale (MOS) from baseline, at 10 sessions of treatment, and at 30 days after the end of the training. The MOS grading the patient's pelvic floot muscles' strength on a 0 to 5 scale, accordingly:
0=No contraction
- =Flicker of movement
- =Through full range actively with gravity counterbalanced 3=Through full range actively against gravity 4=Through full range actively against some resistance 5=Through full range actively against strong resistance
Measured: Baseline, after 5 weeks of treatment , and 1 month after the end of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start20 Apr 2021
- Primary completion10 Jun 2021
- Study completion8 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S. Fondazione Santa Lucia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Tramontano, I.R.C.C.S. Fondazione Santa Lucia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05954234
- Sponsor's protocol ID
- CE/PROG.593
- Status last verified
- Jul 2023
- First submitted
- 7 Apr 2023
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Pelvic Floor Rehabilitation With Postural Re-education in Women With Stress Urinary Incontinence and Chronic Low Back Pain: a Preliminary Study.
- ClinicalTrials.gov ID
- NCT05954234
- Acronym / sponsor ID
- CE/PROG.593
- Conditions
- Stress Urinary Incontinence, Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- I.R.C.C.S. Fondazione Santa LuciaUniversity, hospital or other
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 10 Jun 2021 (actual)
- Study completion
- 8 Aug 2022 (actual)
- First posted
- 20 Jul 2023 (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.
Stress Urinary incontinence (SUI) is a common health condition in female population. Although its prevalence increases with the age, women of all ages could be affected. Several epidemiological studies have shown an association of SUI with Low Back Pain (LBP) demonstrating, moreover, that the presence of one condition may predispose the patient to the onset of the other. Concerning the LBP, the clinical practice guidelines provided recommendations for physical rehabilitative treatment. Different techniques and physical exercises have been developed and it is difficult at the date to affirm the superiority of one approach as compared to another. Moreover, the crucial role plays by the pelvic floor muscles (PFM) both as an integral part of trunk and lumbo-pelvic stability and in maintenance of urinary continence, lead the pelvic floor muscles disfunction to be associated both with SUI and LBP, making the PFM rehabilitation a useful approach in both the conditions. In this rehabilitative context the present study aims to verify the effectiveness of a global physical approach based on postural re-education combined to the pelvic floor rehabilitation in women with diagnosis of stress urinary incontinence associated with non-specific chronic low back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pelvic floor rehabilitation and postural re-education | Active comparator | Other: Postural re-education, Other: Perineal Exercises |
| pelvic floor rehabilitation and spinal mobilization | Active comparator | Other: Spinal mobilization, Other: Perineal Exercises |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- woman aged from 18 to 75 years;
- diagnosis of Stress Urinary Incontinence associated with non-specific chronic Low Back Pain
Key exclusion criteria (9 listed)
- severe pelvic organs prolapse (>second stage following the International Continence Society (ICS) classification);
- pregnancy;
- perineal denervation;
- inverted perineal command;
- presence of pelvic pain;
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 |
|---|---|---|
| Postural re-educationEach session of the experimental approach will be composed of 40 minutes of postural exercise. Participants will be asked to maintain two different postures to stretch both the anterior and posterior muscle chains. The first posture will consist of lying on the back maintaining the extension of the legs to release the respiratory diaphragm and stretch the anterior muscle chain. For the second posture, participants wiil be asked to lie on their back with their legs flexed to stretch the posterior chai. For each posture, the physical therapist will use verbal commands and manual contact to maintain alignment and make the necessary postural corrections to optimize the stretching and discourage compensatory movements. 10 sessions of the allocated intervention will be performed and organized in 2 times a week for 5 weeks. | Other | pelvic floor rehabilitation and postural re-education |
| Spinal mobilizationThis approach will consist of 40 minutes of thoracolumbar spine mobilization. Two different mobilizations will be carried out. In the first one the patient will be in sitting position with both legs out of the bed and a mobilization in antero-posterior direction will be provide by the physiotherapist; the second one will consist in rotational mobilisation provide with the patient in lateral decubitus position. 10 sessions of the allocated intervention will be performed and organized in 2 times a week for 5 weeks. | Other | pelvic floor rehabilitation and spinal mobilization |
| Perineal ExercisesPerineal Exercises will be performed in both the allocated approach. The protocol will consist in 10 minutes of perineal contraction and relaxation and 10 minutes of stretch-reflex for a total of 20 minutes of perineal exercises.10 sessions of the allocated intervention will be performed and organized in 2 times a week for 5 weeks. | Other | pelvic floor rehabilitation and postural re-education, pelvic floor rehabilitation and spinal mobilization |
Primary outcome
International Consultation on Incontinence Questionnaire-Urinary Short Form (ICIQ-UI SF)
Time frame: Baseline, after after 5 weeks of treatment , and 1 month after the end of training
Change of International Consultation on Incontinence Questionnaire-Urinary Short Form (ICIQ-UI SF) from baseline, at 10 sessions of treatment, and at 30 days after the end of the training. The ICIQ-UI SF evaluate the frequency, severity and impact on quality of life (QoL) of urinary incontinence. It is ranging from 0 to 21 where 0 is the minimum and 21 the maximum. An higer score indicates greater impairment from incontinence.
2 secondary outcomes
Pain Visual Analogue Scale (VAS)
Time frame: Baseline, after 5 weeks of treatment , and 1 month after the end of training
Modified Oxford Scale (MOS)
Time frame: Baseline, after 5 weeks of treatment , and 1 month after the end of training
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 20 Jul 2023.
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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 Postural re-education, Spinal mobilization and Perineal Exercises in people with Stress Urinary Incontinence and Low Back Pain, run by I.R.C.C.S. Fondazione Santa Lucia 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 9 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 20 Jul 2023. 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?
International Consultation on Incontinence Questionnaire-Urinary Short Form (ICIQ-UI SF) (time frame: Baseline, after after 5 weeks of treatment , and 1 month after the end of training). 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 20 Jul 2023.