RecruitingPhase 4NCT07473310

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

Low-intensity Shockwave Therapy Versus Solifenacin for the Treatment of Overactive Bladder in Women: A Randomized Controlled Trial

Sponsor

Mansoura University

Enrollment

70 participants

Start Date

Nov 11, 2025

Study Type

INTERVENTIONAL

Conditions

Overactive Bladder (OAB)

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria3

OAB symptoms persisting for ≥3 months.
OAB Symptom Score (OABSS) ≥7.
Ability and willingness to provide informed consent

Exclusion Criteria11

Active urinary tract infection.
Stress urinary incontinence as primary diagnosis.
Pelvic organ prolapse stage ≥II.
History of pelvic radiation or surgery within 6 months.
Use of anticholinergics or β3-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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Interventions

OTHERLow 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).

DRUGOral Solifenacin succinate 5 mg

Participants will receive solifenacin succinate 5 orally once daily for 12 months