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

Not Applicable

Completed

• Conditions: Stress Urinary Incontinence; Low Back Pain
• Interventions: Other: Spinal mobilization; Other: Postural re-education; Other: Perineal Exercises

• Registration Number: NCT05954234
• Lead Sponsor: I.R.C.C.S. Fondazione Santa Lucia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-20
• Primary Completion: 2021-06-10
• Study Completion: 2022-08-08
• Study First Submitted: 2023-04-07
• Status Verified: 2023-07
• Study First Submitted QC: 2023-07-12
• Last Update Submitted: 2023-07-12
• Study First Posted: 2023-07-20
• Last Update Posted: 2023-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pelvic floor rehabilitation and postural re-education	Perineal Exercises	-
pelvic floor rehabilitation and spinal mobilization	Spinal mobilization	-
pelvic floor rehabilitation and postural re-education	Postural re-education	-
pelvic floor rehabilitation and spinal mobilization	Perineal Exercises	-

Primary Outcome Measures

Name	Time	Method
International Consultation on Incontinence Questionnaire-Urinary Short Form (ICIQ-UI SF)	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 Outcome Measures

Name	Time	Method
Pain Visual Analogue Scale (VAS)	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.
Modified Oxford Scale (MOS)	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; 1. =Flicker of movement; 2. =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

Trial Locations

Locations (1)

Marco Tramontano; 🇮🇹 Roma, Rm, Italy