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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Participants will receive Li-SWT which will be applied once weekly for 8 weeks, with a focused shockwave. The bladder will be scanned by US to ensure that t is filled with approximately 50% of the maximum cytometric capacity as measure by baseline cystometry. The patients will be asked to lie flat in a supine position. The device will be operated by a well-trained urologist. A commercially used gel for sonography will be applied to suprapubic region. The applicator will be applied to the S.P region in 3 horizontal sites. 2 cm from each other and 2 fingerbreadths above the pubic bone with 45° tilt. Li-SWT will be applied with energy density of 0.12 mJ/mm² and frequency of 4 pulses/second for a total of 3000 pulses per session (1000 pulses per bladder dome and each lateral wall at 45° tilt).
Participants will receive solifenacin succinate 5 orally once daily for 12 months
Mansoura Faculty of medicine
Al Mansurah, Dakahlia Governorate, Egypt
RECRUITINGChanges in Overactive Bladder Symptom Score (OABSS) from baseline to different points of follow up
self administered questionnaire with minimum score of 0 and maximum score of 15, higher score means worse symptoms
Time frame: Baseline and 3 months
Changes in frequency on three-day urinary diary
Changes in the mean number of voiding episodes per days as measure by a self administered three-day urinary diary
Time frame: from baseline to 1, 3, 6,9 and 12 months
Changes in number of urgency episodes on three-day urinary diary
Changes in the mean number of urgency episodes per day (strong desire to void that cannot be postponed or withheld) as measured by a self administered three-day voiding diary
Time frame: baseline to 1, 2, 3,6,9 and 12 months
Changes in number of nocturia episodes on three-day urinary diary
changes in the mean number of nocturia episodes per night(waking up in the middle of the night to void) as measured by a self-administered three-day voiding diary
Time frame: baseline to 1, 2, 3,6,9 and 12 months
Changes in number of incontinence episodes on three-day urinary diary
Changes in number of incontinence episodes per day (involuntary leakage of urine) as measured by a self administered three-day urinary diary
Time frame: form baseline to 1,2,3,6,9 and 12 months
changes in International Consultation on Incontinence Questionnaire- Urinary Incontinence-Short Form (ICIQ-UI-SF) score
self administered questionnaire with minimum score of 0 and maximum score of 21, the higher score, the worse the symptoms
Time frame: form baseline to 1,2,3,6,9 and 12 months
changes in Overactive bladder quality of life questionnaire (ICIQ-OABqol)
self administered questionnaire with minimum score of 25 and maximum score of 160 , higher score indicated worse effect on the quality of life
Time frame: from baseline to 1,2,3,6,9 and 12 months
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