Urinary Incontinence
Conditions
Keywords
Urinary incontinence, Pelvic floor, Lumbopelvic static, Posturography
Brief summary
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.
Interventions
BEHAVIORALPelvic Floor Muscle Training
Pelvic 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.
BEHAVIORALPosturography Rehabilitation
Postural 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.
Sponsors
Mohammed V University in Rabat
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Participants are randomly assigned to two parallel groups: a combined pelvic floor muscle training and lumbopelvic postural rehabilitation group, and a pelvic floor muscle training alone group.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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 * Written informed consent provided prior to participation in the study
Exclusion criteria
* 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) * Current urinary tract infection or vaginal infection * Cognitive or visual impairments that may interfere with understanding or performing the exercise program * Pregnant women or women within 10 months postpartum * Anticholinergic medication use or hormone replacement therapy within the last 6 months * Recent pelvic or abdominal surgery within the last 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF) | 6 weeks and 12 weeks from start of intervention | 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
| Measure | Time frame | Description |
|---|---|---|
| Patient Global Impression of Improvement (PGI-I) | 6 weeks and 12 weeks from start of intervention | 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 | 6 weeks and 12 weeks from start of intervention | 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) | 6 weeks and 12 weeks from start of intervention | 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) | 6 weeks and 12 weeks from start of intervention | 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. |
Countries
Morocco
Contacts
Primary ContactKhaoula Mestour
Outcome results
None listed