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

RecruitingPhase 4Ages 18 Years - anyFemaleMansoura University
NCT07473310 on ClinicalTrials.gov โ†—
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * OAB symptoms persisting for โ‰ฅ3 months. * OAB Symptom Score (OABSS) โ‰ฅ7. * Ability and willingness to provide informed consent Exclusion Criteria: * Active urinary tract infection. * Stress urinary incontinence as primary diagnosis. * Pelvic organ prolapse stage โ‰ฅII. * History of pelvic radiation or surgery within 6 months. * Use of anticholinergics or ฮฒ3-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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What it tests

  • Low intensity shockwave therapy
  • Oral Solifenacin succinate 5 mg
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Where

1 site
Mansoura Faculty of medicine
Al Mansurah, Egypt
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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