Effect of urinary muscle exercises on urinary leakage in women with stroke

Effect of Pelvic Floor Rehabilitation in Stroke (PFloRiS) on Urinary Incontinence in Community Dwelling Women Stroke Survivors - PFloRiS Trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/01/061825

Enrollment

Registered

2024-01-24

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I635- Cerebral infarction due to unspecified occlusion or stenosis of cerebral arteries Health Condition 2: G819- Hemiplegia, unspecified Health Condition 3: I62- Other and unspecified nontraumaticintracranial hemorrhage

Interventions

Intervention1: Pelvic Floor Rehabilitation in Stroke (PFloRiS): The PFloRiS model will be designed for pelvic floor rehabilitation in stroke survivors. It will be available for use by trained professi

Eligibility

Inclusion criteria

Inclusion criteria: 1. Women with onset of stroke = 1 month 2. Who have a complaint of involuntary loss of urine while coughing, sneezing 3. Women who have symptoms of urge urinary incontinence 4. Functional comprehension and communication 5. Medically stable

Exclusion criteria

Exclusion criteria: 1. Presence of pelvic floor dysfunctions before stroke 2. Lower urinary tract infections 3. Cystopathies 4. Medications that affect bladder function 5. Pelvic and hip fractures 6. Pelvic surgeries that affect bladder function 7. Other neurological disorders 8. Severe diabetes mellitus affecting bladder function 9. Cognitive impairment (Montreal Cognitive Assessment = 26) 10. NIH Stroke Scale = 25 11. Severe comorbidities such as renal failure, dementia, Alzheimer’s disease 12. Severe perceptual, visual or auditory disturbances

Design outcomes

Primary

Measure	Time frame
International Consultation on Incontinence Questionnaire for Urinary Incontinence Short form (ICIQ-UI-SF)Timepoint: Baseline, 6 weeks, 12 weeks	—

Secondary

Measure	Time frame
Electromyographic (EMG) AnalysisTimepoint: Baseline, 6 weeks, 12 weeks;ICIQ-Bladder diaryTimepoint: Baseline, 6 weeks, 12 weeks;Incontinence Quality of Life (I-QOL) questionnaireTimepoint: Baseline, 6 weeks, 12 weeks;International Consultation on Incontinence Questionnaire for Female Lower Urinary Tract Symptoms Long Form Module (ICIQ-FLUTS-LF)Timepoint: Baseline, 6 weeks, 12 weeks;Modified Oxford ScaleTimepoint: Baseline, 6 weeks, 12 weeks;Stroke Pelvic Floor and Perineal Health Questionnaire (SPFPH)Timepoint: Baseline, 6 weeks, 12 weeks	—

Measure

Time frame

Electromyographic (EMG) AnalysisTimepoint: Baseline, 6 weeks, 12 weeks;ICIQ-Bladder diaryTimepoint: Baseline, 6 weeks, 12 weeks;Incontinence Quality of Life (I-QOL) questionnaireTimepoint: Baseline, 6 weeks, 12 weeks;International Consultation on Incontinence Questionnaire for Female Lower Urinary Tract Symptoms Long Form Module (ICIQ-FLUTS-LF)Timepoint: Baseline, 6 weeks, 12 weeks;Modified Oxford ScaleTimepoint: Baseline, 6 weeks, 12 weeks;Stroke Pelvic Floor and Perineal Health Questionnaire (SPFPH)Timepoint: Baseline, 6 weeks, 12 weeks

—

Countries

India

Contacts

Public ContactDr John Solomon M

Manipal College of Health Professions

preetha.r@manipal.edu9945670669

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026