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

Mansoura University

Status and phase: Enrolling; Phase 4

Conditions: Overactive Bladder (OAB); Urge Incontinence

Treatments: Other: Low intensity shockwave therapy; Drug: Oral Solifenacin succinate 5 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT07473310

MD.25.08.1022

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

LiSWT group

Experimental group

Description:

Allocated to receive LiSWT

Treatment:

Other: Low intensity shockwave therapy

Solifenacin Group

Active Comparator group

Description:

Allocated to receive oral Solifenacin succinate 5 mg

Treatment:

Drug: Oral Solifenacin succinate 5 mg