NCT07473310 Low-intensity Shockwave Therapy Versus Solifenacin for the Treatment of Overactive Bladder in Women
| NCT ID | NCT07473310 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Mansoura University |
| Condition | Overactive Bladder (OAB) |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2025-11-11 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 70 participants in total. It began in 2025-11-11 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to evaluate the effectiveness and safety of low-intensity shockwave therapy (Li-SWT) for the treatment of overactive bladder (OAB) in adult women. The main questions this study aims to answer are whether Li-SWT improves overactive bladder symptoms and quality of life, and whether these improvements are sustained over a 12-month follow-up period, compared with standard medical therapy. Researchers will compare Li-SWT with oral solifenacin succinate, a commonly used antimuscarinic medication for OAB. Participants will be randomly assigned to receive either Li-SWT once weekly for 8 weeks or solifenacin 5 mg taken orally once daily for 12 months. All participants will complete symptom questionnaires and three-day voiding diaries and will undergo uroflowmetry, post-void residual measurement, and filling cystometry at specified time points during follow-up.
Eligibility 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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07473310 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Overactive Bladder (OAB). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07473310 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07473310 currently recruiting?
Yes, NCT07473310 is actively recruiting participants. Contact the research team at Hossam.Yahya@yahoo.com for enrollment information.
Where is the NCT07473310 trial being conducted?
This trial is being conducted at Al Mansurah, Egypt.
Who is sponsoring the NCT07473310 clinical trial?
NCT07473310 is sponsored by Mansoura University. The trial plans to enroll 70 participants.