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Low-Intensity Shock Wave Therapy for Refractory Overactive Bladder in Women
Sponsor: Al-Azhar University
Summary
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.
Official title: Therapeutic Effects of Low-Intensity Extracorporeal Shock Wave Therapy on Refractory Overactive Bladder Symptoms in Females
Key Details
Gender
FEMALE
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2026-08-01
Completion Date
2027-02-01
Last Updated
2026-07-31
Healthy Volunteers
No
Conditions
Interventions
Low-Intensity Extracorporeal Shock Wave Therapy
Focused low-intensity extracorporeal shock wave therapy will be delivered using the PiezoWave 2 device. Each session will deliver a total of 3000 impulses at an energy density of 0.25 mJ/mm² and a frequency of 3 pulses per second. Treatment will be administered once weekly for 6 weeks.
Sham Low-Intensity Extracorporeal Shock Wave Therapy
A sham procedure will be administered using the same treatment setup, participant positioning, probe placement, session duration, and device sound as active therapy. A sham probe or zero-energy setting will be used so that no therapeutic shock wave energy is delivered. The procedure will be performed once weekly for 6 weeks.
Locations (1)
Ain Shams University Hospital
Cairo, Cairo Governorate, Egypt