Low-Intensity Shock Wave Therapy for Refractory Overactive Bladder in Women

Starting soon · Not applicable · Has a placebo group

Conditions studied: Urinary Bladder, Overactive

In brief

Overactive bladder is a condition characterized by a sudden and difficult-to-control need to urinate, which may occur with frequent urination, nighttime urination, and urine leakage. Some women continue to experience these symptoms despite lifestyle changes, behavioral therapy, and medication, or they cannot tolerate or decline medical treatment. This study will evaluate whether low-intensity extracorporeal shock wave therapy (Li-ESWT), a non-surgical treatment delivered externally over the lower abdomen, can safely improve refractory overactive bladder symptoms in women. A total of 40 women will be randomly assigned in equal numbers to receive either active Li-ESWT or a sham treatment. Both groups will attend one treatment session each week for six weeks. The sham procedure will be similar to the active treatment in positioning, session duration, and device sound but will not deliver shock wave energy. Symptoms will be assessed using the validated Arabic version of the 8-item Overactive Bladder Questionnaire (OAB-V8) before treatment and during follow-up. The main purpose of the study is to compare the change in OAB-V8 symptom score between the two groups after one month. Additional assessments at three months will include post-void residual urine volume, information from a 3-day voiding diary, the participant's overall impression of improvement, and any treatment-related adverse events. The study hypothesis is that Li-ESWT will improve overactive bladder symptoms and quality of life compared with sham treatment.

Key facts

Study ID

NCT07739550

Run by

Al-Azhar University

People needed

40

Starts

2026-08-01

Expected to finish

2027-02-01

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older, up to 70. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female participants aged 18 to 70 years.
• Symptoms of overactive bladder with an Overactive Bladder Questionnaire 8-Item total score greater than 8.
• Failure of behavioral therapy and medical treatment for overactive bladder.
• Refusal of medical treatment for overactive bladder. Ability to understand the study procedures and provide written informed consent.

You may not qualify if…

• Current use of medical treatment for overactive bladder.
• Cardiac pacemaker or metallic implant in the treatment area.
• Coagulation disorder or use of anticoagulants that cannot be temporarily discontinued.
• Active urinary tract infection; participants may be reconsidered after successful treatment and recovery.
• Urinary bladder stones.
• Post-void residual urine volume greater than 100 mL.
• Lower urinary tract surgery within the previous 6 months.
• Previous pelvic radiation therapy.
• History of neuropathic disease.
• Pregnancy or planning to become pregnant.
• Hepatic, renal, or cardiac impairment.

Where it is running

• Ain Shams University Hospital — Cairo, Cairo Governorate, Egypt

Full record on ClinicalTrials.gov

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