Posturography Rehabilitation and Pelvic Floor Training on Urinary Incontinence in Women

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorMohammed V University in Rabat

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Pelvic Floor Muscle Training

    Behavioral

    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.

  • Posturography Rehabilitation

    Behavioral

    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.

Treatment groups

78 Participants
are divided into 2 treatment groups
Group A: Combined Pelvic Floor Muscle Training and Posturography RehabilitationExperimental treatment 2 interventions
Group B: Pelvic Floor Muscle Training AloneActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
6 weeks and 12 weeks from start of intervention

Secondary outcomes

1

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".

Time frame
6 weeks and 12 weeks from start of intervention
2

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.

Time frame
6 weeks and 12 weeks from start of intervention
3

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)

Time frame
6 weeks and 12 weeks from start of intervention
4

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.

Time frame
6 weeks and 12 weeks from start of intervention

Other outcomes

Sponsors and contacts

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