Low-intensity shockwave versus daily solifenacin for women's overactive bladder
Low-intensity Shockwave Therapy Versus Solifenacin for the Treatment of Overactive Bladder in Women: A Randomized Controlled Trial
PHASE4 · Mansoura University · NCT07473310
This test compares once-weekly low-intensity shockwave therapy with daily solifenacin to see which better reduces overactive bladder symptoms in adult women.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Mansoura University (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Al Mansurah, Dakahlia Governorate) |
| Trial ID | NCT07473310 on ClinicalTrials.gov |
What this trial studies
In this randomized Phase 4 trial adult women with overactive bladder are assigned to receive either once-weekly low-intensity shockwave therapy for 8 weeks or oral solifenacin 5 mg daily for 12 months. Participants complete symptom questionnaires and three-day bladder diaries and undergo uroflowmetry, post-void residual measurement, and filling cystometry at scheduled visits. The study follows patients for up to 12 months to see how symptoms and quality of life change and whether any benefits are sustained. Safety and tolerability of Li-SWT are monitored and compared with standard medical therapy.
Who should consider this trial
Good fit: Adult women with OAB symptoms for at least 3 months and an OAB Symptom Score (OABSS) of 7 or higher who can provide informed consent are ideal candidates.
Not a fit: Patients with predominant stress urinary incontinence, stage II or greater pelvic organ prolapse, active urinary tract infection, uncontrolled diabetes, relevant neurologic disease, or contraindications to solifenacin may not benefit from this comparison.
Why it matters
Potential benefit: If successful, Li-SWT could offer a non-drug, office-based option that reduces OAB symptoms and improves quality of life with durable effects.
How similar studies have performed: Small pilot studies and early trials of low-intensity shockwave therapy for bladder dysfunction have shown promising symptom improvements, but larger randomized data are still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * OAB symptoms persisting for ≥3 months. * OAB Symptom Score (OABSS) ≥7. * Ability and willingness to provide informed consent Exclusion Criteria: * Active urinary tract infection. * Stress urinary incontinence as primary diagnosis. * Pelvic organ prolapse stage ≥II. * History of pelvic radiation or surgery within 6 months. * Use of anticholinergics or β3-agonists for the past 4 weeks who are unwilling to undergo washout. * Pregnancy or breast feeding. * Neuropathic diseases or psychological disorders. * History of urogenital malignancy. * Uncontrolled DM (HbA1c \> 6.8) * Uncorrected coagulopathy or severe cardiovascular disease. * Contraindication to solifenacin e.g.: closed angle glaucoma)
Where this trial is running
Al Mansurah, Dakahlia Governorate
- Mansoura Faculty of medicine — Al Mansurah, Dakahlia Governorate, Egypt (RECRUITING)
Study contacts
- Study coordinator: Yahya H Elmorsy
- Email: Hossam.Yahya@yahoo.com
- Phone: 00201100311999
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Overactive Bladder, Urge Incontinence, OAB, overactive bladder, low intensity shockwave, solifenacin