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Recruiting Phase 4 NCT07473310

Low-intensity Shockwave Therapy Versus Solifenacin for the Treatment of Overactive Bladder in Women

Trial Parameters

Condition Overactive Bladder (OAB)
Sponsor Mansoura University
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 70
Sex FEMALE
Min Age 18 Years
Max Age N/A
Start Date 2025-11-11
Completion 2027-06
Interventions
Low intensity shockwave therapyOral Solifenacin succinate 5 mg

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)

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