An interventional study of Low-Intensity Extracorporeal Shock Wave Therapy and Sham Low-Intensity Extracorporeal Shock Wave Therapy in Urinary Bladder, Overactive, sponsored by Al-Azhar University. Not yet recruiting at 1 site in Egypt. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-07-31.
Sponsored by Al-Azhar University · Not applicable, Interventional, and Treatment
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.
858 studies on the registry are indexed under Urinary Bladder, Overactive; 127 are open to participants now.
This study's planned enrollment of 40 is below the median of 70 across 649 interventional studies indexed under Urinary Bladder, Overactive.
Browse Urinary Bladder, Overactive studies →Al-Azhar University is the lead sponsor of 531 studies on the registry; 172 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive active low-intensity extracorporeal shock wave therapy using the PiezoWave 2 focused extracorporeal shock wave therapy device. Treatment will be administered once weekly for 6 weeks. Before each session, participants will drink 1000 mL of water, and treatment will begin when the bladder reaches approximately 50% of the participant's functional bladder capacity, confirmed by bladder scan. The probe will be placed over the lower abdomen approximately two fingerbreadths above the pubic symphysis and directed toward the bladder dome and bilateral bladder walls. Each session will deliver 1000 impulses to each target area, for a total of 3000 impulses, at an energy density of 0.25 mJ/mm² and a frequency of 3 pulses per second.
Device: Low-Intensity Extracorporeal Shock Wave Therapy
Participants will receive a sham procedure once weekly for 6 weeks. The procedure will be similar to the active treatment in participant positioning, bladder preparation, probe placement, session duration, and device sound. A sham probe or zero-energy device setting will be used so that no therapeutic shock wave energy is delivered.
Device: Sham 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.
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.
Overactive Bladder Questionnaire 8-Item Total Score
The Arabic-validated Overactive Bladder Questionnaire 8-Item (OAB-V8) will be completed at baseline and 1 month after completion of treatment. The questionnaire contains 8 items scored from 0 to 5, giving a total score ranging from 0 to 40. Higher scores indicate greater symptom-related bother. The outcome will be calculated as the change in total OAB-V8 score from baseline to the 1-month assessment.
Time frame: Baseline and 1 month after completion of the 6-week treatment
Post-Void Residual Urine Volume at 3 Months
Post-void residual urine volume will be measured by ultrasound after urination and recorded in milliliters. The outcome will be calculated as the change from baseline to the 3-month follow-up assessment.
Time frame: Baseline and 3 months after completion of treatment
Urinary Frequency Recorded in a 3-Day Voiding Diary
Participants will record the timing and number of urination episodes in a 3-day voiding diary. The outcome will assess the change in urinary frequency from baseline to the 3-month follow-up assessment.
Time frame: Baseline and 3 months after completion of treatment
Mean Voided Urine Volume Recorded in a 3-Day Voiding Diary
The volume of urine passed during each urination will be recorded in milliliters in a 3-day voiding diary. Mean voided volume will be calculated, and the change from baseline to the 3-month follow-up assessment will be evaluated.
Time frame: Baseline and 3 months after completion of treatment
Urgency Level Recorded in a 3-Day Voiding Diary
Participants will record the level of urinary urgency associated with each urination episode in a 3-day voiding diary. The outcome will assess the change in recorded urgency level from baseline to the 3-month follow-up assessment.
Time frame: Baseline and 3 months after completion of treatment
Urinary Leakage Episodes Recorded in a 3-Day Voiding Diary
The number of involuntary urinary leakage episodes will be recorded over 3 consecutive days. The outcome will be calculated as the change in the number of leakage episodes from baseline to the 3-month follow-up assessment.
Time frame: Baseline and 3 months after completion of treatment
Functional Bladder Capacity
Functional bladder capacity will be derived from measurements recorded in the participant's 3-day voiding diary and expressed in milliliters. The outcome will assess the change from baseline to the 3-month follow-up assessment.
Time frame: Baseline and 3 months after completion of treatment
Start is estimated for Aug 2026; primary completion for Feb 2027, 6 months later.
Of 133 non-industry interventional studies with no phase under Urinary Bladder, Overactive, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 40. This study's planned 6 months is below that.
Counting every sponsor, half of 174 studies reached it within 19 months; a quarter within 10 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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