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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Low intensity shockwave therapy
Other interventionParticipants 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).
Oral Solifenacin succinate 5 mg
DrugParticipants will receive solifenacin succinate 5 orally once daily for 12 months
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: LiSWT groupExperimental treatment 1 intervention
Group B: Solifenacin GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Changes 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 monthsSecondary outcomes
1
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 months2
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 months3
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 months4
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 monthsSponsors and contacts
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Source ClinicalTrials.gov