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

NCT07739550 | Not Yet Recruiting

• 1 other identifier: FMASU MS 434/2026
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Bladder, Overactive

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 1 month after completion of the 6-week treatment

Secondary Outcomes (6)

• Post-Void Residual Urine Volume at 3 Months

  Baseline and 3 months after completion of treatment

• Urinary Frequency Recorded in a 3-Day Voiding Diary

  Baseline and 3 months after completion of treatment

• Mean Voided Urine Volume Recorded in a 3-Day Voiding Diary

  Baseline and 3 months after completion of treatment

• Urgency Level Recorded in a 3-Day Voiding Diary

  Baseline and 3 months after completion of treatment

• Urinary Leakage Episodes Recorded in a 3-Day Voiding Diary

  Baseline and 3 months after completion of treatment

Study Arms (2)

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.

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.

Device: Sham Low-Intensity Extracorporeal Shock Wave Therapy

Interventions

Low-Intensity Extracorporeal Shock Wave Therapy DEVICE

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.

Active Low-Intensity Extracorporeal Shock Wave Therapy

Sham Low-Intensity Extracorporeal Shock Wave Therapy DEVICE

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.

Sham Low-Intensity Extracorporeal Shock Wave Therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Ain Shams University Hospital

Cairo, Cairo Governorate, 11511, Egypt

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive; Nocturia

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Abdelrahman F Senosy, MBBCh

CONTACT

010 95324741; Abdelrahmanadam96@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Urology

Model Details: 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.

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: July 31, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: July 31, 2026

Record last verified: 2026-07

Locations

EG (1)