Status:
UNKNOWN
The Effect of Low Intensity Extracorporeal Low Energy Shock Wave Therapy on Stress Urinary Incontinence and Overactivity Bladder
Lead Sponsor:
Kaohsiung Medical University Chung-Ho Memorial Hospital
Conditions:
Stress Urinary Incontinence
Overactive Bladder
Eligibility:
FEMALE
20-75 years
Phase:
NA
Brief Summary
The hypothesis of the present study is low intensity extracorporeal low energy shock wave therapy (LiESWT) can decrease inflammatory disorders, increase pelvic floor blood supply, enhanced bladder ste...
Detailed Description
Clinical application of low intensity extracorporeal low energy shock wave therapy (LiESWT) (2000 to 3000 impulses in 0.20-0.25 millijoule/mm2 (mJ/mm2)) initiated wound healing, promoted angiogenesis,...
Eligibility Criteria
Inclusion
- Women patients within 20\~75 years old;
- OAB symptoms for ≥ 3 months;
- Frequency of micturition ≥ 8 times daytime as well as 2 times nighttime, and ≥ 2 episodes of urgency per week;
- Patients have a ≥ 3 month history of experiencing Stress Urinary Incontinence (SUI) per week (self reported);
- Patients with OAB symptoms including urgency or/and urgency incontinence, urinary frequency and nocturia in the previous 3 months without medical treatments: antimuscarinic or ß3 agonist therapy;
- Patients can understand, obey order and finish the questionnaires;
- Patients would like to sign the informed consent;
- Signature of informed consent form.
Exclusion
- Urinary tract infection (UTI) at screening and recurrent UTI defined as ≥ 3 UTIs in the previous 12 months;
- Patients who have other disease: diabetes mellitus, spinal cord injury, stoke history, brain disease and neurogenic disease which can cause OAB;
- Chronic urologic inflammatory condition (Interstitial cystitis, urethral syndrome, painful bladder syndrome);
- Bladder stone;
- History of carcinoma of the urinary tract;
- Lower urinary tract surgery in the last 6 months;
- Patients who have operation, wound or infection around perineum;
- Patients who have catheterization due to poor voiding function of urine;
- Patients who have severe cardiovascular disease;
- Patients who have severe coagulopathy or liver failure or renal failure;
- Patients who have underlying urologic cancer;
- Subjects with gross hematuria;
- Significant bladder outflow obstruction;
- Previous pelvic radiation therapy or previous, current malignant disease of the pelvic organs or having received intravesical injection or electrostimulation in the past 12 months;
- Drug or nondrug treatments of OAB (in the previous 14 days), Concomitant medications that affect detrusor activity;
- Subjects with history of kidneys stones;
- Treatable condition that could cause urinary incontinence or urgency;
- Neurological impairment or psychiatric disorder preventing appropriate understanding of consent and ability to comply with site personnel instructions;
- History of drug or alcohol abuse within the last 12 months;
- Within 1 month before entering the test and receive low-energy in vitro shock wave treatment process using antibiotics or phosphodiesterase inhibitors type 5 (PDE5i);
- There are chronic pelvic pains caused by the merger of other diseases or injuries;
- Urinary incontinence need to install the catheter;
- Severe cardiopulmonary disease or diabetes is obviously poor control;
- Obvious coagulation dysfunction or liver and kidney dysfunction.
Key Trial Info
Start Date :
February 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2020
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT04059133
Start Date
February 27 2018
End Date
July 31 2020
Last Update
August 20 2019
Active Locations (1)
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1
Kaohsiung Medical University Hospital
Kaohsiung City, Taiwan, 807