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Combining Pelvic Floor Rehabilitation With Postural Re-education in Women With Stress Urinary Incontinence and Chronic Low Back Pain: a Preliminary Study.

Primary Purpose

Stress Urinary Incontinence, Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Postural re-education
Spinal mobilization
Perineal Exercises
Sponsored by
I.R.C.C.S. Fondazione Santa Lucia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: woman aged from 18 to 75 years; diagnosis of Stress Urinary Incontinence associated with non-specific chronic Low Back Pain Exclusion Criteria: 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; vaginal infections; associated pathologies involving the Central Nervous System (CNS); psychotic disorders

Sites / Locations

  • Marco Tramontano

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

pelvic floor rehabilitation and postural re-education

pelvic floor rehabilitation and spinal mobilization

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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

Full Information

First Posted
April 7, 2023
Last Updated
July 12, 2023
Sponsor
I.R.C.C.S. Fondazione Santa Lucia
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1. Study Identification

Unique Protocol Identification Number
NCT05954234
Brief Title
Combining Pelvic Floor Rehabilitation With Postural Re-education in Women With Stress Urinary Incontinence and Chronic Low Back Pain: a Preliminary Study.
Official Title
Combining Pelvic Floor Rehabilitation With Postural Re-education in Women With Stress Urinary Incontinence and Chronic Low Back Pain: a Preliminary Study.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
April 20, 2021 (Actual)
Primary Completion Date
June 10, 2021 (Actual)
Study Completion Date
August 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
I.R.C.C.S. Fondazione Santa Lucia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence, Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pelvic floor rehabilitation and postural re-education
Arm Type
Active Comparator
Arm Title
pelvic floor rehabilitation and spinal mobilization
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Postural re-education
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Spinal mobilization
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Perineal Exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
International Consultation on Incontinence Questionnaire-Urinary Short Form (ICIQ-UI SF)
Description
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.
Time Frame
Baseline, after after 5 weeks of treatment , and 1 month after the end of training
Secondary Outcome Measure Information:
Title
Pain Visual Analogue Scale (VAS)
Description
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.
Time Frame
Baseline, after 5 weeks of treatment , and 1 month after the end of training
Title
Modified Oxford Scale (MOS)
Description
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
Time Frame
Baseline, after 5 weeks of treatment , and 1 month after the end of training

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: woman aged from 18 to 75 years; diagnosis of Stress Urinary Incontinence associated with non-specific chronic Low Back Pain Exclusion Criteria: 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; vaginal infections; associated pathologies involving the Central Nervous System (CNS); psychotic disorders
Facility Information:
Facility Name
Marco Tramontano
City
Roma
State/Province
Rm
ZIP/Postal Code
00179
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

Combining Pelvic Floor Rehabilitation With Postural Re-education in Women With Stress Urinary Incontinence and Chronic Low Back Pain: a Preliminary Study.

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