Extracorporeal Shock Wave Therapy to Kegel's Exercise in Management of Female Stress Urinary

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age25-60
SponsorSuez Canal University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • low-intensity extracorporeal shock (LiESWT)

    Radiation

    receives 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)

    Behavioral

    Daily 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

84 Participants
are divided into 2 treatment groups
Group A: Low-intensity extracorporeal shock (LiESWT) + Kegel's exercise (KE)Active comparator 2 interventions
Group B: Kegel's exercise (KE) onlyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Patients will be assessed at 4 weeks, 8 weeks, 12 weeks, and 3 months from the date of the intervention startup.

Secondary outcomes

1

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)

Time frame
Patients will be assessed at 4 weeks, 8 weeks, 12 weeks, and 3 months from the date of the intervention startup.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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