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

July 28, 2026 updated by: Abdelrahman Farid Adam Senosy, Al-Azhar University

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.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Cairo Governorate
      • Cairo, Cairo Governorate, Egypt, 11511

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active Low-Intensity Extracorporeal Shock Wave Therapy
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
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 Comparator: Sham 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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overactive Bladder Questionnaire 8-Item Total Score
Time Frame: 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.
Baseline and 1 month after completion of the 6-week treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-Void Residual Urine Volume at 3 Months
Time Frame: 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.
Baseline and 3 months after completion of treatment
Urinary Frequency Recorded in a 3-Day Voiding Diary
Time Frame: 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.
Baseline and 3 months after completion of treatment
Mean Voided Urine Volume Recorded in a 3-Day Voiding Diary
Time Frame: 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.
Baseline and 3 months after completion of treatment
Urgency Level Recorded in a 3-Day Voiding Diary
Time Frame: 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.
Baseline and 3 months after completion of treatment
Urinary Leakage Episodes Recorded in a 3-Day Voiding Diary
Time Frame: 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.
Baseline and 3 months after completion of treatment
Functional Bladder Capacity
Time Frame: 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.
Baseline and 3 months after completion of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Azhar University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

July 28, 2026

First Submitted That Met QC Criteria

July 28, 2026

First Posted (Actual)

July 31, 2026

Study Record Updates

Last Update Posted (Actual)

July 31, 2026

Last Update Submitted That Met QC Criteria

July 28, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU MS 434/2026

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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