Low-intensity Shockwave Therapy Versus Solifenacin for the Treatment of Overactive Bladder in Women
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMansoura University
About this trial
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
Qualifiers
OAB symptoms persisting for ≥3 months.
OAB Symptom Score (OABSS) ≥7.
Ability and willingness to provide informed consent
Disqualifiers
Active urinary tract infection.
Stress urinary incontinence as primary diagnosis.
Pelvic organ prolapse stage ≥II.
History of pelvic radiation or surgery within 6 months.
Trial design
Treatments tested in this trial
- Low intensity shockwave therapy
- Oral Solifenacin succinate 5 mg
Treatment groups
70 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov