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NCT Number: NCT07739550

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

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.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University Hospital

Cairo, Cairo Governorate, 11511, Egypt

Location contact

Abdelrahman F Senosy, MBBCh

CONTACT

[email protected]

010 95324741 ext. +2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Abdelrahman F Senosy, MBBCh

CONTACT

[email protected]

010 95324741 ext. +02

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

Therapeutic Effects of Low-Intensity Extracorporeal Shock Wave Therapy on Refractory Overactive Bladder Symptoms in Females

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 31, 2026
Registry last updated
Jul 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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