- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07663968
Extracorporeal Shock Wave Therapy to Kegel's Exercise in Management of Female Stress Urinary
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
Stato
Condizioni
Intervento / Trattamento
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
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Abdelrhman Alshawadfy, Professor
- Numero di telefono: 002 +201091091620
- Email: abdelrhmanalshawadfy@gmail.com
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
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
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:
|
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
Sponsor
Investigatori
- Direttore dello studio: Abdelrhman Alshawadfy, Faculty of Medicine, Suez Canal University Ismailia, , Egypt
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
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)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
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)
-
Beijing Jishuitan HospitalSconosciuto
-
Gymna UniphyFRAME Jessa Ziekenhuis, BelgiumCompletatoSpasticità dovuta a paralisi cerebrale | Spasticità Lesione cerebrale post-traumaticaBelgio
-
Northeast College of Health SciencesRitiratoMal di schiena acutaStati Uniti
-
Assiut UniversityNon ancora reclutamento
-
ZHANG PENGZhongda HospitalNon ancora reclutamentoEpicondilite laterale (gomito del tennista)Cina
-
University of Sao Paulo General HospitalNon ancora reclutamento
-
Sungjin ParkNon ancora reclutamento
-
MTI UniversityCompletato