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

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.

Study Overview

• Status: Recruiting
• Conditions: Urge Incontinence; Overactive Bladder (OAB)
• Intervention / Treatment: Other: Low intensity shockwave therapy; Drug: Oral Solifenacin succinate 5 mg

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Yahya H Elmorsy; Phone Number: 00201100311999; Email: Hossam.Yahya@yahoo.com

Study Locations

• Egypt
  • Dakahlia Governorate
    • Al Mansurah, Dakahlia Governorate, Egypt, 35111
      • Recruiting
      • Mansoura Faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LiSWT group; Allocated to receive LiSWT	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).
Active Comparator: Solifenacin Group; Allocated to receive oral Solifenacin succinate 5 mg	Drug: Oral Solifenacin succinate 5 mg; Participants will receive solifenacin succinate 5 orally once daily for 12 months

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in frequency on three-day urinary diary	Changes in the mean number of voiding episodes per days as measure by a self administered three-day urinary diary	from baseline to 1, 3, 6,9 and 12 months
Changes in number of urgency episodes on three-day urinary diary	Changes in the mean number of urgency episodes per day (strong desire to void that cannot be postponed or withheld) as measured by a self administered three-day voiding diary	baseline to 1, 2, 3,6,9 and 12 months
Changes in number of nocturia episodes on three-day urinary diary	changes in the mean number of nocturia episodes per night(waking up in the middle of the night to void) as measured by a self-administered three-day voiding diary	baseline to 1, 2, 3,6,9 and 12 months
Changes in number of incontinence episodes on three-day urinary diary	Changes in number of incontinence episodes per day (involuntary leakage of urine) as measured by a self administered three-day urinary diary	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	self administered questionnaire with minimum score of 0 and maximum score of 21, the higher score, the worse the symptoms	form baseline to 1,2,3,6,9 and 12 months
changes in Overactive bladder quality of life questionnaire (ICIQ-OABqol)	self administered questionnaire with minimum score of 25 and maximum score of 160 , higher score indicated worse effect on the quality of life	from baseline to 1,2,3,6,9 and 12 months

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: December 27, 2025
• First Submitted That Met QC Criteria: March 10, 2026
• First Posted (Actual): March 16, 2026

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: overactive bladder; OAB; solifenacin; low intensity shockwave
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder Diseases; Urinary Incontinence; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Urinary Bladder, Overactive; Urinary Incontinence, Urge; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, Bridged-Ring; Tetrahydroisoquinolines; Isoquinolines; Quinuclidines; Solifenacin Succinate
• Other Study ID Numbers: MD.25.08.1022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No