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RECRUITING
NCT07473310
PHASE4

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

Sponsor: Mansoura University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2025-11-11

Completion Date

2027-12

Last Updated

2026-03-16

Healthy Volunteers

No

Interventions

OTHER

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).

DRUG

Oral Solifenacin succinate 5 mg

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

Locations (1)

Mansoura Faculty of medicine

Al Mansurah, Dakahlia Governorate, Egypt