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

Condition(s) studied

Investigational drug(s) / intervention(s)

Low intensity shockwave therapy: 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).

Oral Solifenacin succinate 5 mg: Participants will receive solifenacin succinate 5 orally once daily for 12 months

Study 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

Primary outcome measure(s)

• Changes in Overactive Bladder Symptom Score (OABSS) from baseline to different points of follow up — Baseline and 3 months
  self administered questionnaire with minimum score of 0 and maximum score of 15, higher score means worse symptoms

Trial sites (1)

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