Urinary Bladder, Overactive
Conditions
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
Brief 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.
Interventions
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.
DEVICESham 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.
Sponsors
Al-Azhar University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants and outcome assessors will be unaware of treatment allocation. The sham procedure will reproduce the active treatment positioning, session duration, and device sound but will not deliver shock wave energy. The urologist administering the intervention will not be masked because the active and sham procedures require different device settings. Randomization codes will be concealed using sealed opaque envelopes prepared by an independent third party not involved in participant recruitment or outcome assessment.
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overactive Bladder Questionnaire 8-Item Total Score | Baseline and 1 month after completion of the 6-week treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-Void Residual Urine Volume at 3 Months | Baseline and 3 months after completion of treatment | 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. |
| Urinary Frequency Recorded in a 3-Day Voiding Diary | Baseline and 3 months after completion of treatment | 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. |
| Mean Voided Urine Volume Recorded in a 3-Day Voiding Diary | Baseline and 3 months after completion of treatment | 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. |
| Urgency Level Recorded in a 3-Day Voiding Diary | Baseline and 3 months after completion of treatment | 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. |
| Urinary Leakage Episodes Recorded in a 3-Day Voiding Diary | Baseline and 3 months after completion of treatment | 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. |
| Functional Bladder Capacity | Baseline and 3 months after completion of treatment | 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. |
Countries
Egypt
Contacts
CONTACTAbdelrahman F Senosy, MBBCh
Outcome results
None listed