Urinary Bladder, OveractiveNCT07739550
Low-Intensity Shock Wave Therapy for Refractory Overactive Bladder in Women
A study testing Low-Intensity Extracorporeal Shock Wave Therapy in people with Urinary Bladder, Overactive, run by Al-Azhar University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Urinary Bladder, Overactive
- What is being tested?
- Low-Intensity Extracorporeal Shock Wave Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2026to 1 Feb 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Ain Shams University Hospital
Cairo, Cairo Governorate, 11511
Abdelrahman F Senosy, MBBCh, 010 95324741 ext. +2, Abdelrahmanadam96@gmail.com
About this study
Official title: Therapeutic Effects of Low-Intensity Extracorporeal Shock Wave Therapy on Refractory Overactive Bladder Symptoms in Females
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.
Read more
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.
- Conditions
- Urinary Bladder, Overactive
- Being tested
- Low-Intensity Extracorporeal Shock Wave Therapy, Sham Low-Intensity Extracorporeal Shock Wave Therapy
- Keywords
- Refractory Overactive Bladder, Low-Intensity Extracorporeal Shock Wave Therapy, Female Lower Urinary Tract Symptoms, Urinary Urgency, Urinary Frequency, Nocturia, Urgency Urinary Incontinence, Functional Bladder Capacity, Post-Void Residual Urine, Sham-Controlled Clinical Trial, Overactive Bladder Questionnaire, 8-Item
- Medical subject headings
- Urinary Bladder, Overactive, Nocturia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Intensity Extracorporeal Shock Wave TherapyDevice
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 TherapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Active Low-Intensity Extracorporeal Shock Wave Therapy | Experimental | 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. Receives: Device: Low-Intensity Extracorporeal Shock Wave Therapy |
| Sham Low-Intensity Extracorporeal Shock Wave Therapy | Sham comparator | 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. Receives: Device: Sham Low-Intensity Extracorporeal Shock Wave Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 1 month after completion of the 6-week treatment
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 3 months after completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Bladder, OveractiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1 ratio to one of two parallel study arms. The experimental arm will receive active low-intensity extracorporeal shock wave therapy, and the comparator arm will receive sham treatment. Both groups will receive one session weekly for 6 weeks and will remain in their assigned arms throughout the study. Outcomes will be evaluated at baseline, 1 month, and 3 months.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrahman Farid Adam Senosy, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07739550
- Sponsor's protocol ID
- FMASU MS 434/2026
- Status last verified
- Jul 2026
- First submitted
- 28 Jul 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No