Clinical trial NCT05954234: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence
Low Back Pain
Lead sponsor: I.R.C.C.S. Fondazione Santa Lucia
Sponsor class: OTHER
First posted: 2023-07-20
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: International Consultation on Incontinence Questionnaire-Urinary Short Form (ICIQ-UI SF)
timeFrame: Baseline, after after 5 weeks of treatment , and 1 month after the end of training
Secondary outcomes:
measure: Pain Visual Analogue Scale (VAS)
timeFrame: Baseline, after 5 weeks of treatment , and 1 month after the end of training
measure: Modified Oxford Scale (MOS)
timeFrame: Baseline, after 5 weeks of treatment , and 1 month after the end of training
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Marco Tramontano
state: Rm
Study officials:
References: