NCT07337278

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 20, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 1, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 13, 2026

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

January 13, 2026

Status Verified

January 1, 2026

Enrollment Period

2 months

First QC Date

January 1, 2026

Last Update Submit

January 1, 2026

Conditions

Keywords

Urinary incontinence, Pelvic floor, Lumbopelvic static, Posturography

Outcome Measures

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.

    6 weeks and 12 weeks from start of intervention

Secondary Outcomes (4)

  • Patient Global Impression of Improvement (PGI-I)

    6 weeks and 12 weeks from start of intervention

  • Urinary Symptom Profile (USP) scores

    6 weeks and 12 weeks from start of intervention

  • Pelvic Floor Muscle Strength (Modified Oxford Scale)

    6 weeks and 12 weeks from start of intervention

  • Incontinence Impact Questionnaire - Short Form (IIQ-7)

    6 weeks and 12 weeks from start of intervention

Study Arms (2)

Combined Pelvic Floor Muscle Training and Posturography Rehabilitation

EXPERIMENTAL

Participants receive pelvic floor muscle training combined with lumbopelvic rehabilitation using posturography for a total duration of 12 weeks.

Behavioral: Pelvic Floor Muscle TrainingBehavioral: Posturography Rehabilitation

Pelvic Floor Muscle Training Alone

ACTIVE COMPARATOR

Participants receive pelvic floor muscle training alone for a total duration of 12 weeks.

Behavioral: Pelvic Floor Muscle Training

Interventions

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.

Combined Pelvic Floor Muscle Training and Posturography RehabilitationPelvic Floor Muscle Training Alone

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.

Combined Pelvic Floor Muscle Training and Posturography Rehabilitation

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al Ayachi Hospital, CHU Ibn Sina

Rabat, Rabat-Salé-Kénitra, 10000, Morocco

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident in Physical and Rehabilitation Medicine

Study Record Dates

First Submitted

January 1, 2026

First Posted

January 13, 2026

Study Start

November 20, 2025

Primary Completion

February 1, 2026

Study Completion

March 1, 2026

Last Updated

January 13, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations