- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Abdelrhman Alshawadfy, Professor
- Telefonnummer: 002 +201091091620
- E-mail: abdelrhmanalshawadfy@gmail.com
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: 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.
|
|
Aktiv komparator: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in frequency and severity of stress urinary incontinence episodes
Tidsramme: 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.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in quality of life
Tidsramme: 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.
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Abdelrhman Alshawadfy, Faculty of Medicine, Suez Canal University Ismailia, , Egypt
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- extracorporeal shock
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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