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

Official title

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

Overview

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.

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 reg
• Drug Oral Solifenacin succinate 5 mg
  Participants will receive solifenacin succinate 5 orally once daily for 12 months

Primary outcome measures

• Changes in Overactive Bladder Symptom Score (OABSS) from baseline to different points of follow up [Time frame: Baseline and 3 months]

Secondary outcome measures (6)

• Changes in frequency on three-day urinary diary [Time frame: from baseline to 1, 3, 6,9 and 12 months]
• Changes in number of urgency episodes on three-day urinary diary [Time frame: baseline to 1, 2, 3,6,9 and 12 months]
• Changes in number of nocturia episodes on three-day urinary diary [Time frame: baseline to 1, 2, 3,6,9 and 12 months]
• Changes in number of incontinence episodes on three-day urinary diary [Time frame: form baseline to 1,2,3,6,9 and 12 months]
• changes in International Consultation on Incontinence Questionnaire- Urinary Incontinence-Short Form (ICIQ-UI-SF) score [Time frame: form baseline to 1,2,3,6,9 and 12 months]
• changes in Overactive bladder quality of life questionnaire (ICIQ-OABqol) [Time frame: from baseline to 1,2,3,6,9 and 12 months]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Egypt · 1 center

• Mansoura Faculty of medicine — Al Mansurah

Identifiers

NCT: NCT07473310 · MD.25.08.1022

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗