Skip to main content
OpenTrials
Completed

NCT Number: NCT05954234

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stress Urinary Incontinence Back Pain Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Low Back Pain Lower Urinary Tract Symptoms Male Urogenital Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Marco Tramontano

Roma, Rm, 00179, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Pain Visual Analogue Scale (VAS)

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

    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.

  2. Modified Oxford Scale (MOS)

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

    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

Sponsors and collaborators

Lead sponsor

I.R.C.C.S. Fondazione Santa Lucia

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Jul 20, 2023
Registry last updated
Jul 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.