- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Abdelrhman Alshawadfy, Professor
- Telefonní číslo: 002 +201091091620
- E-mail: abdelrhmanalshawadfy@gmail.com
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: 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.
|
|
Aktivní komparátor: 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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in frequency and severity of stress urinary incontinence episodes
Časové okno: 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.
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in quality of life
Časové okno: 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.
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Abdelrhman Alshawadfy, Faculty of Medicine, Suez Canal University Ismailia, , Egypt
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- extracorporeal shock
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na low-intensity extracorporeal shock (LiESWT)
-
Hacettepe UniversityNáborPrst na spoušti | Stenózní tenosynovitidaTurecko (Türkiye)
-
Yuzuncu Yıl UniversityZápis na pozvánkuPatelární tendinitidaKrocan
-
Yuzuncu Yıl UniversityDokončenoOsteoartróza kyčleKrocan
-
Cheng-Hsin General HospitalStaženoPrst na spoušti | Stenózní tenosynovitida
-
Istanbul UniversityIstanbul University - Cerrahpasa (IUC)Zatím nenabírámeCalcinosis Cutis | Sklerodermie
-
University Hospital Schleswig-HolsteinDokončenoNeporušená scaphoidní kost | Intaktní záprstní kost | Zlomenina scaphoidní kosti | Zlomenina záprstní kostiNěmecko
-
Medical University of SilesiaNeznámýSyndrom patelofemorální bolesti | Chronická bolest kolenPolsko
-
Konya Meram State HospitalNáborLaterální epikondylitidaKrocan
-
KTO Karatay UniversityDokončenoBolest | Nemoci nohou | Plantární fasciitidaKrocan
-
Istanbul Medeniyet UniversityDokončenoLaterální epikondylitida | Tenisový loketKrocan