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

18 giugno 2026 aggiornato da: Abdelrhman Alshawadfy, Suez Canal University

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

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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

84

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Low-intensity extracorporeal shock (LiESWT) + Kegel's exercise (KE)

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.

In addition to daily Kegel's exercise (KE) for 8 weeks.

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.
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.
Comparatore attivo: Kegel's exercise (KE) only
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.
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in frequency and severity of stress urinary incontinence episodes
Lasso di tempo: Patients will be assessed at 4 weeks, 8 weeks, 12 weeks, and 3 months from the date of the intervention startup.

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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in quality of life
Lasso di tempo: Patients will be assessed at 4 weeks, 8 weeks, 12 weeks, and 3 months from the date of the intervention startup.

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)

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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Direttore dello studio: Abdelrhman Alshawadfy, Faculty of Medicine, Suez Canal University Ismailia, , Egypt

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 luglio 2026

Completamento primario (Stimato)

30 luglio 2027

Completamento dello studio (Stimato)

30 ottobre 2027

Date di iscrizione allo studio

Primo inviato

11 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

18 giugno 2026

Primo Inserito (Effettivo)

23 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

23 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

18 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • extracorporeal shock

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su low-intensity extracorporeal shock (LiESWT)

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