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NCT Number: NCT07473310

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

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.

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Key information

Conditions

Overactive Bladder (OAB) Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urge Incontinence Urinary Bladder Diseases Urinary Bladder, Overactive Urinary Incontinence Urinary Incontinence, Urge Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Mansoura Faculty of medicine

Al Mansurah, Dakahlia Governorate, 35111, Egypt

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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).

Oral Solifenacin succinate 5 mg

Drug

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

Primary outcomes

  1. Changes in Overactive Bladder Symptom Score (OABSS) from baseline to different points of follow up

    Time frame: Baseline and 3 months

    self administered questionnaire with minimum score of 0 and maximum score of 15, higher score means worse symptoms

Secondary outcomes

  1. Changes in frequency on three-day urinary diary

    Time frame: from baseline to 1, 3, 6,9 and 12 months

    Changes in the mean number of voiding episodes per days as measure by a self administered three-day urinary diary

  2. 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 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

  3. 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 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

  4. 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 number of incontinence episodes per day (involuntary leakage of urine) as measured by a self administered three-day urinary diary

  5. 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

    self administered questionnaire with minimum score of 0 and maximum score of 21, the higher score, the worse the symptoms

  6. changes in Overactive bladder quality of life questionnaire (ICIQ-OABqol)

    Time frame: from baseline to 1,2,3,6,9 and 12 months

    self administered questionnaire with minimum score of 25 and maximum score of 160 , higher score indicated worse effect on the quality of life

Study contacts

Contact information is provided by the study sponsor or research team.

Yahya H Elmorsy

CONTACT

[email protected]

00201100311999

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 16, 2026
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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