About this trial
Stress urinary incontinence (SUI) is a common pelvic floor disorder among women, especially those with a history of childbirth, aging, or pelvic surgery. Stress urinary incontinence is defined as the complaint of involuntary leakage on effort or exertion, or on sneezing or coughing.
The condition significantly affects quality of life, emotional well-being, and daily functioning.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Married Females
Diagnosed with stress urinary incontinence, confirmed by clinical evaluation.
Ability and willingness to perform KE and attend follow-up visits.
Accepting informed consent.
Disqualifiers
Mixed urinary incontinence.
Active urinary tract infection (symptomatic or laboratory) confirmed).
Known coagulopathy or ongoing anticoagulant therapy.
Neurological disorders (e.g., multiple sclerosis, stroke, spinal cord injury) or use of medications affecting bladder control.
Trial design
Parallel
Treatments tested in this trial
low-intensity extracorporeal shock (LiESWT)
Radiationreceives low-intensity extracorporeal shock (LiESWT) once weekly. Frequency: 3 Hz, 3000 shocks/session; Duration: 15-20 minutes/session placed on the perineal region, the left side, and the right side of the labia minora.
Kegel's exercises (KE)
BehavioralDaily Kegel's exercise (KE) Frequency: 3 sessions/day each A session is 10 repetitive pelvic floor muscle contractions. Each contraction will be held for 5 seconds, followed by 5 seconds of relaxation for 8 weeks.
Treatment groups
Trial outcomes
Primary outcomes
Change in frequency and severity of stress urinary incontinence episodes
Change in frequency and severity of stress urinary incontinence episodes, evaluated by the validated International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) The ICIQ-SF consists of three main questions that contribute to the overall score. Each question is scored as follows: 1. Frequency of leakage: 0 (Never) to 5 (All the time) 2. Volume of leakage: 0 (None) to 6 (A large amount) 3. Impact on daily life: 0 (Not at all) to 10 (A very great deal) Total Score Range: Minimum Value: 0 (indicating no urinary incontinence, no leakage, and no impact on quality of life) Maximum Value: 21 (indicating severe urinary incontinence, with frequent leakage and a significant impact on daily life) The total score allows healthcare providers to evaluate the severity of a patient's urinary incontinence and track changes over time.
Secondary outcomes
Change in quality of life
Change in quality of life, assessed by the Incontinence Quality of Life Questionnaire (I-QOL). The Incontinence Quality of Life Questionnaire (I-QOL) is a specific tool designed to assess the impact of urinary incontinence on an individual's quality of life. It consists of various items that evaluate how incontinence affects aspects such as emotional well-being, social interactions, and everyday activities. The Incontinence Quality of Life Questionnaire (I-QOL) scoring system generally ranges in total scores from 0 to 100. Minimum Value: 0 (indicating the lowest quality of life due to urinary incontinence) Maximum Value: 100 (indicating the highest quality of life with no impact from urinary incontinence)
Locations
Sponsors and contacts
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