Clinical trial NCT04059133: The Effect of Low Intensity Extracorporeal Low Energy Shock Wave Therapy on Stress Urinary Incontinence and Overactivity Bladder
Official title: The Effect of Low Intensity Extracorporeal Low Energy Shock Wave Therapy on Stress Urinary Incontinence and Overactivity Bladder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress Urinary Incontinence
Overactive Bladder
Keywords: low intensity extracorporeal low energy shock wave therapy
stress urinary incontinence
overactive bladder
urine leakage
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2019-08-16
Enrollment: 180
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 stem cell activation, Using LiESWT can decrease bladder overactivity, eliminate urinary incontinence and improve stress urinary incontinence (SUI) and overactive bladder (OAB) symptoms. Therefore improve quality of life and improve social activity.

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, reduced the level of oxidative stress, induced the releasing of VEGF, stimulated proliferation and differentiation of stem cells, and resulted in the effect of anti-inflammatory and tissue regeneration. Generally, LiESWT was used clinically to improve tissue regeneration at tendon-bone junctions, ischemic cardiovascular disorders, skin wound healing, chronic injuries of soft tissues and erectile dysfunction.

LiESWT has also been shown to increase vascular endothelial growth factor (VEGF) expression in ischemic tissues in vivo and to promote angiogenesis and functional recovery in models of chronic myocardial ischemia, myocardial infarction, and peripheral artery disease. Importantly, the advantages of LiESWT include therapies without medication or surgery, outpatient therapies, short treatment sessions, no anesthesia required, and non-invasive therapy.

The hypothesis of the present study is LiESWT can decrease inflammatory disorders, increase pelvic floor blood supply, enhanced bladder stem cell activation, Using LiESWT can decrease bladder overactivity, eliminate urinary incontinence and improve stress urinary incontinence (SUI) and overactive bladder (OAB) symptoms. Therefore improve quality of life and improve social activity.

Eligibility criteria: Inclusion Criteria:

1. Women patients within 20\~75 years old;
2. OAB symptoms for ≥ 3 months;
3. Frequency of micturition ≥ 8 times daytime as well as 2 times nighttime, and ≥ 2 episodes of urgency per week;
4. Patients have a ≥ 3 month history of experiencing Stress Urinary Incontinence (SUI) per week (self reported);
5. 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;
6. Patients can understand, obey order and finish the questionnaires;
7. Patients would like to sign the informed consent;
8. Signature of informed consent form.

Exclusion Criteria:

1. Urinary tract infection (UTI) at screening and recurrent UTI defined as ≥ 3 UTIs in the previous 12 months;
2. Patients who have other disease: diabetes mellitus, spinal cord injury, stoke history, brain disease and neurogenic disease which can cause OAB;
3. Chronic urologic inflammatory condition (Interstitial cystitis, urethral syndrome, painful bladder syndrome);
4. Bladder stone;
5. History of carcinoma of the urinary tract;
6. Lower urinary tract surgery in the last 6 months;
7. Patients who have operation, wound or infection around perineum;
8. Patients who have catheterization due to poor voiding function of urine;
9. Patients who have severe cardiovascular disease;
10. Patients who have severe coagulopathy or liver failure or renal failure;
11. Patients who have underlying urologic cancer;
12. Subjects with gross hematuria;
13. Significant bladder outflow obstruction;
14. 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;
15. Drug or nondrug treatments of OAB (in the previous 14 days), Concomitant medications that affect detrusor activity;
16. Subjects with history of kidneys stones;
17. Treatable condition that could cause urinary incontinence or urgency;
18. Neurological impairment or psychiatric disorder preventing appropriate understanding of consent and ability to comply with site personnel instructions;
19. History of drug or alcohol abuse within the last 12 months;
20. 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);
21. There are chronic pelvic pains caused by the merger of other diseases or injuries;
22. Urinary incontinence need to install the catheter;
23. Severe cardiopulmonary disease or diabetes is obviously poor control;
24. Obvious coagulation dysfunction or liver and kidney dysfunction.

Primary outcomes:
measure: Pad Weight Difference
timeFrame: Data will be analyzed at study completion at approximately 3 years.
measure: Overactive bladder symptoms scores (OABSS)
timeFrame: Data will be analyzed at study completion at approximately 3 years.
measure: International Consultation on Incontinence Questionnaire -- Short Form (ICIQ-SF)
timeFrame: Data will be analyzed at study completion at approximately 3 years.
measure: Urogenital distress inventory (UDI-6)
timeFrame: Data will be analyzed at study completion at approximately 3 years.
measure: Incontinence impact questionnaire -7 (IIQ-7)
timeFrame: Data will be analyzed at study completion at approximately 3 years.
Secondary outcomes:
measure: maximum flow rate(Qmax=cc/s)
timeFrame: Data will be analyzed at study completion at approximately 3 years.
measure: Uroflow
timeFrame: Data will be analyzed at study completion at approximately 3 years.
measure: postvoid residual urine volume (PVR)
timeFrame: Data will be analyzed at study completion at approximately 3 years.
measure: 3-day micturition diary
timeFrame: Data will be analyzed at study completion at approximately 3 years.
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Hospital
Study officials:
References:
citation: Long CY, Lin KL, Lee YC, Chuang SM, Lu JH, Wu BN, Chueh KS, Ker CR, Shen MC, Juan YS. Therapeutic effects of Low intensity extracorporeal low energy shock wave therapy (LiESWT) on stress urinary incontinence. Sci Rep. 2020 Apr 2;10(1):5818. doi: 10.1038/s41598-020-62471-4.