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Clinical Trials/NCT05954234
NCT05954234
Completed
Not Applicable

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

I.R.C.C.S. Fondazione Santa Lucia1 site in 1 country30 target enrollmentApril 20, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stress Urinary Incontinence
Sponsor
I.R.C.C.S. Fondazione Santa Lucia
Enrollment
30
Locations
1
Primary Endpoint
International Consultation on Incontinence Questionnaire-Urinary Short Form (ICIQ-UI SF)
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 20, 2021
End Date
August 8, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
I.R.C.C.S. Fondazione Santa Lucia
Responsible Party
Principal Investigator
Principal Investigator

Marco Tramontano

Head of Rehabilitation Services

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

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

Outcomes

Primary Outcomes

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

  • 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 Sites (1)

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