The Effect of Low Intensity Extracorporeal Low Energy Shock Wave Therapy on Stress Urinary Incontinence and Overactivity Bladder

NCT04059133 | Unknown

• 1 other identifier: KMUHIRB-F(II)-20180010
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Urinary Incontinence; Overactive Bladder

Keywords

low intensity extracorporeal low energy shock wave therapy; stress urinary incontinence; overactive bladder; urine leakage

Outcome Measures

Primary Outcomes (5)

• Pad Weight Difference

  The pad test quantifies in grams urinary loss through the absorbent weighing as a measure of stress urinary incontinence.

  Data will be analyzed at study completion at approximately 3 years.

• Overactive bladder symptoms scores (OABSS)

  Change in OABSS scores during LiESWT treatment and follow-up period.

  Data will be analyzed at study completion at approximately 3 years.

• International Consultation on Incontinence Questionnaire -- Short Form (ICIQ-SF)

  Change in ICIQ-SF scores during LiESWT treatment and follow-up period.

  Data will be analyzed at study completion at approximately 3 years.

• Urogenital distress inventory (UDI-6)

  Change in UDI-6 scores during LiESWT treatment and follow-up period.

  Data will be analyzed at study completion at approximately 3 years.

• Incontinence impact questionnaire -7 (IIQ-7)

  Change in IIQ-7 scores during LiESWT treatment and follow-up period.

  Data will be analyzed at study completion at approximately 3 years.

Secondary Outcomes (4)

• maximum flow rate(Qmax=cc/s)

  Data will be analyzed at study completion at approximately 3 years.

• Uroflow

  Data will be analyzed at study completion at approximately 3 years.

• postvoid residual urine volume (PVR)

  Data will be analyzed at study completion at approximately 3 years.

• 3-day micturition diary

  Data will be analyzed at study completion at approximately 3 years.

Study Arms (2)

LiESWT arm

EXPERIMENTAL

1. For SUI: The LiESWT was applied with 0.25 mJ/mm2 intensity, 3000 pulses of shocks, and frequency of 3 pulses/second, once weekly for 4-weeks (W4) and 8-weeks (W8). Probe be transcutaneous applied to the left and right labia minora of the genital area, and the applicator was gently placed on the middle, the left side and the right side of the labia with 0.25 mJ/mm2 intensity and 1000 pulses of shocks individually. 2. For OAB: The LiESWT was applied with 0.25 mJ/mm2 intensity, 3000 pulses of shocks, and frequency of 3 pulses/second, once weekly for 4-weeks (W4) and 8-weeks (W8). Probe be transcutaneous applied to the lower abdomen with two fingers apart from the pubic symphysis, tilting to 45°, and the applicator was gently placed on suprapubic skin area over the bladder dome and bilateral bladder walls with 0.25 mJ/mm2 intensity and 1000 pulses of shocks individually.

Device: DUOLITH SD1-TOP focused shock wave system (STORZ MEDICAL EvoTronTM, GA)-LiESWT arm

Sham arm

SHAM COMPARATOR

1. For SUI: The LiESWT was applied with 3000 pulses of shocks, frequency of 3 pulses/second but no energy, once weekly for 4-weeks (W4) and 8-weeks (W8). Probe be transcutaneous applied to the left and right labia minora of the genital area, and the applicator was gently placed on the middle, the left side and the right side of the labia with 0.25 mJ/mm2 intensity and 1000 pulses of shocks individually. 2. For OAB: The LiESWT was applied with 3000 pulses of shocks, frequency of 3 pulses/second but no energy, once weekly for 4-weeks (W4) and 8-weeks (W8). The applicator was gently placed on the suprapubic skin area over the bladder dome (1000 pulses) and bilateral bladder walls (each side 1000 pulses). The probe was placed on the lower abdomen with two fingers apart from the pubic symphysis, tilting to 45°.

Device: DUOLITH SD1-TOP focused shock wave system (STORZ MEDICAL EvoTronTM, GA)-Sham arm

Interventions

DUOLITH SD1-TOP focused shock wave system (STORZ MEDICAL EvoTronTM, GA)-Sham arm DEVICE

Sham treatment (shock wave probe w/o energy)

Sham arm

DUOLITH SD1-TOP focused shock wave system (STORZ MEDICAL EvoTronTM, GA)-LiESWT arm DEVICE

Low intensity extracorporeal low energy shock wave treatment (shock wave probe w/ energy)

LiESWT arm

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

Study Sites (1)

Kaohsiung Medical University Hospital

Kaohsiung City, 807, Taiwan

RECRUITING

Related Publications (1)

• 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.

  PMID: 32242035 DERIVED

MeSH Terms

Conditions

Urinary Incontinence, Stress; Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; 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; Urinary Bladder Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2019
• First Posted: August 16, 2019
• Study Start: February 27, 2018
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: August 20, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)