About this trial
The goal of this clinical trial is to evaluate whether lumbopelvic postural rehabilitation combined with pelvic floor muscle training (PFMT) is more effective than PFMT alone in women with urinary incontinence. The main questions it aims to answer are:
* Does the addition of lumbopelvic postural rehabilitation improve the severity of urinary incontinence as measured by the ICIQ-UI-SF questionnaire? * Does it improve urinary symptom profile, pelvic floor muscle strength, patient-reported overall improvement, and quality of life compared to PFMT alone?
Participants will be randomly assigned to one of two groups:
* Experimental group (Group A): PFMT (3 sessions/week) plus lumbopelvic postural rehabilitation (2 sessions/week) for 12 weeks. * Control group (Group B): PFMT alone (3 sessions/week) for 12 weeks. Participants will perform pelvic floor exercises in supine and seated positions, with supervised sessions at the hospital and home exercises. Postural rehabilitation includes stability and mobility exercises for the lumbopelvic region using Posturography. Outcomes will be assessed at baseline, at 6 weeks, and at 12 weeks.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female participants aged between 18 and 65 years
Presence of clinical signs of urinary incontinence (stress urinary incontinence and/or urge urinary incontinence and/or mixed urinary incontinence) diagnosed according to the International Continence Society (ICS) terminology
USP (urinary symptom profile) scores for stress urinary incontinence and/or overactive bladder ≥ 1
Normal neuro-perineal examination
Disqualifiers
Known detrusor overactivity or reduced bladder compliance of neurological origin
Associated voiding dysfunction, defined as a Urinary Symptom Profile (USP) dysuria subscale score ≥ 1
Known organic or morphological pathology of the lower urinary tract
Pelvic organ prolapse grade II or higher according to the Pelvic Organ Prolapse Quantification system (POP-Q)
Trial design
Parallel
Treatments tested in this trial
Pelvic Floor Muscle Training
BehavioralPelvic floor training consists of voluntary contractions of the pelvic floor muscles, using short, rapid contractions combined with slow, sustained contractions, aimed at improving strength and endurance. Training is performed in supine and seated positions, with one supervised session per week at the hospital and three home sessions per week, over a total duration of 12 weeks.
Posturography Rehabilitation
BehavioralPostural rehabilitation consists of seated exercises focusing on stability and mobility of the lumbopelvic region, using posturography. Sessions last 30 minutes, conducted twice weekly, over a total duration of 12 weeks.
Treatment groups
Trial outcomes
Primary outcomes
International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF)
The primary outcome is the severity of urinary incontinence measured by the ICIQ-UI-SF. This validated questionnaire assesses frequency, quantity, and impact of leaks on quality of life. The overall score is obtained by adding up the 3 questions, ranging from 0 to 21, with a higher score indicating more severe symptoms.
Secondary outcomes
Patient Global Impression of Improvement (PGI-I)
PGI-I is a patient-reported questionnaire assessing overall improvement in urinary symptoms compared to baseline. Scores range from "considerably improved" to "considerably worsened".
Urinary Symptom Profile (USP) scores
questionnaire enabling qualitative and quantitative analysis of urinary symptoms of stress urinary incontinence, overactive bladder, and dysuria. We used the subscores for stress urinary incontinence and overactive bladder.
Pelvic Floor Muscle Strength (Modified Oxford Scale)
The modified Oxford scale assesses pelvic floor muscle strength through vaginal palpation and visual observation during maximum voluntary contraction. The classification ranges from 0 (no contraction) to 5 (strong contraction)
Incontinence Impact Questionnaire - Short Form (IIQ-7)
IIQ-7 measures the impact of urinary incontinence on daily activities, social relationships, mobility, and emotional health. Each item is scored from 0 (not at all) to 3 (greatly), with higher total scores indicating greater impact.
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