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Not yet recruiting NCT07663968

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

No phase Interventional Female Stress Urinary Incontinence

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: low-intensity extracorporeal shock (LiESWT), Kegel's exercises (KE).
Who it may be relevant to
Registry conditions: Female Stress Urinary Incontinence. Basic parameters: 25 years — 60 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Additive Role of Low-intensity Extracorporeal Shock Wave Therapy to Kegel's Exercise in Management of Female Stress Urinary Incontinence : A Prospective Randomized Study

Overview

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.

Detailed description

Many women believe that urinary incontinence is an inevitable part of aging or the aftermath of childbirth and do not seek treatment because of embarrassment or a lack of knowledge about available therapies.

The main underlying mechanism of SUI is the weakening of the pelvic floor muscles and connective tissues supporting the bladder and urethra. This structural compromise leads to urethral hypermobility and insufficient urethral closure during physical strain.

Risk factors include vaginal delivery, menopause, obesity, and chronic respiratory conditions.

Effective treatment targets these musculoskeletal deficits to restore continence and reduce leakage episodes.

Kegel's exercise (KE), also known as pelvic floor muscle training, is the first-line conservative treatment for SUI. It involves repetitive contractions and relaxations of pelvic floor muscles to improve their strength, endurance, and coordination.

Pelvic Floor Muscle Training (PFMT) has shown positive outcomes in reducing urinary leakage and improving quality of life. However, patient adherence, correct technique, and the chronicity of symptoms influence its effectiveness. In some cases, KE alone may not provide sufficient relief, especially in moderate to severe SUI.

Low-intensity extracorporeal shock wave therapy (LiESWT) is a non-invasive modality that uses acoustic waves to stimulate tissue regeneration, angiogenesis, and neuromuscular repair. Originally developed for urological and musculoskeletal disorders, its application has expanded to include female pelvic floor dysfunctions. LiESWT has shown promising results in improving urinary control by enhancing blood flow and tissue remodeling in the pelvic region.

Its safety, lack of anesthesia, and outpatient delivery make it an attractive complementary therapy.

The integration of LiESWT with KE is hypothesized to provide synergistic effects.

While Kegel's exercises strengthen muscle tone, LiESWT enhances vascular and cellular repair, potentially accelerating functional improvement. The combination targets both structural and physiological aspects of SUI. This dual approach may be especially beneficial for specific patients who have plateaued with PFMT alone or those seeking non-surgical alternatives with quicker results.

Recent studies have suggested that LiESWT can reduce urinary incontinence severity, but high-quality evidence, especially in combination with PFMT, remains limited. Most available research focuses either on LiESWT or KE separately.

There is a lack of comparative trials directly evaluating the additive benefit of combining both interventions in a structured treatment plan. Therefore, more comprehensive studies are required to determine whether the combination yields superior outcomes in terms of continence, patient satisfaction, and long-term efficacy.

A well-structured clinical comparison between combined LiESWT and KE versus Kegel's alone can fill an essential gap in SUI management. strategies. Such research can provide data on effectiveness, patient compliance, and functional outcomes. It can also guide clinicians on optimizing conservative treatment pathways before progressing to pharmacological or surgical options. Furthermore, evaluating cost-effectiveness and patient-reported outcomes can inform health policy and patient counseling.

The present study aims to assess the additive role of LiESWT to KE for female stress urinary incontinence.

Interventions

  • Radiation low-intensity extracorporeal shock (LiESWT)
    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.
  • Behavioral Kegel's exercises (KE)
    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.

Primary outcome measures

  • Change in frequency and severity of stress urinary incontinence episodes [Time frame: Patients will be assessed at 4 weeks, 8 weeks, 12 weeks, and 3 months from the date of the intervention startup.]
Secondary outcome measures (1)
  • Change in quality of life [Time frame: Patients will be assessed at 4 weeks, 8 weeks, 12 weeks, and 3 months from the date of the intervention startup.]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • Pregnancy or recent childbirth (within 6 months)
  • History of pelvic malignancy affecting urinary continence.
  • History of recent surgical intervention or indicated for surgery for urinary incontinence.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07663968 · extracorporeal shock

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗