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

NCT05954234 | Completed DMC

• 1 other identifier: CE/PROG.593
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Urinary Incontinence; Low Back Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, after after 5 weeks of treatment , and 1 month after the end of training

Secondary Outcomes (2)

• Pain Visual Analogue Scale (VAS)

  Baseline, after 5 weeks of treatment , and 1 month after the end of training

• Modified Oxford Scale (MOS)

  Baseline, after 5 weeks of treatment , and 1 month after the end of training

Study Arms (2)

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

Interventions

Postural re-education OTHER

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.

pelvic floor rehabilitation and postural re-education

Spinal mobilization OTHER

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.

pelvic floor rehabilitation and spinal mobilization

Perineal Exercises OTHER

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.

pelvic floor rehabilitation and postural re-education; pelvic floor rehabilitation and spinal mobilization

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• woman aged from 18 to 75 years;
• diagnosis of Stress Urinary Incontinence associated with non-specific chronic Low Back Pain

You may not qualify if:

• 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

Sponsors & Collaborators

• I.R.C.C.S. Fondazione Santa Lucia: lead

Study Sites (1)

Marco Tramontano

Roma, Rm, 00179, Italy

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress; Low Back Pain

Condition Hierarchy (Ancestors)

Urinary Incontinence; 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; Back Pain; Pain; Neurologic Manifestations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Rehabilitation Services

Study Record Dates

• First Submitted: April 7, 2023
• First Posted: July 20, 2023
• Study Start: April 20, 2021
• Primary Completion: June 10, 2021
• Study Completion: August 8, 2022
• Last Updated: July 20, 2023

Record last verified: 2023-07

Locations

IT (1)