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

NCT07473310 | Recruiting Phase 4

• 1 other identifier: MD.25.08.1022
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Overactive Bladder (OAB); Urge Incontinence

Keywords

OAB; overactive bladder; low intensity shockwave; solifenacin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Changes in frequency on 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

  baseline to 1, 2, 3,6,9 and 12 months

• Changes in number of nocturia episodes on three-day urinary diary

  baseline to 1, 2, 3,6,9 and 12 months

• Changes in number of incontinence episodes on 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

  form baseline to 1,2,3,6,9 and 12 months

Study Arms (2)

LiSWT group

EXPERIMENTAL

Allocated to receive LiSWT

Other: Low intensity shockwave therapy

Solifenacin Group

ACTIVE COMPARATOR

Allocated to receive oral Solifenacin succinate 5 mg

Drug: Oral Solifenacin succinate 5 mg

Interventions

Low intensity shockwave therapy OTHER

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).

LiSWT group

Oral Solifenacin succinate 5 mg DRUG

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

Solifenacin Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura Faculty of medicine

Al Mansurah, Dakahlia Governorate, 35111, Egypt

RECRUITING

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence, Urge

Interventions

Solifenacin Succinate

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Incontinence; Urination Disorders

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Yahya H Elmorsy

CONTACT

00201100311999; Hossam.Yahya@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2025
• First Posted: March 16, 2026
• Study Start: November 11, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

EG (1)