Detrusor, UnderactiveNCT04161183
Extracoporeal Shock Wave Therapy (ESWT) for the Treatment of Detrusor Underactivity/ Underactive Bladder (DU/UAB)
A study testing Extracoporeal shock wave therapy in people with Detrusor, Underactive and Detrusor Underactivity, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
To evaluate the efficacy and safety of ESWT for the treatment of patients with DU/UAB Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Detrusor, Underactive, Detrusor Underactivity
- What is being tested?
- Extracoporeal shock wave therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Oct 2019to 10 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male or female, at least 20 years of age.
- History of UAB (defined as bothersome chronic incomplete bladder emptying) for at least 3 months documented in the medical record with recurring UAB symptoms.
- No UAB symptom relief (unresponsiveness) with previous used medications and/or other treatments.
- Voiding difficulty (complains of difficulty emptying the bladder).
- UAB consistent with diabetes, MS, Parkinson's disease, or aging idiopathic.
- Post void residual ≥ 100 mL.
Show all 15Show fewer
- Bladder capacity > 200 mL and < 800 mL.
- Pressure flow Urodynamic testing demonstrating impaired detrusor contractility or areflexia without evidence of BOO, with maximum detrusor pressure Pdet at Qmax (Pdet@Qmax) of < 20 cmH2O and Maximum flow rate (Qmax) < 15 mL/sec for female, and BCI < 100 and BOOI < 40 for male.
- Total UAB Questionnaire Score ≥ 3.
- Females of child-bearing potential agree to use reliable birth control for the entire study duration.
- Willing and capable of understanding and complying with all requirements of the protocol, including proper completion of the voiding diaries and self-administered questionnaires.
- Free of active urinary tract infection.
- Free of bladder outlet obstruction on enrollment.
- Patient or his/her legally acceptable representative has signed the written informed consent form.
- Subject on clean intermittent catheterization (CIC) should have been on CIC for at least 1 month and should be able to void spontaneously and not be completely dependent on CIC.
Who cannot join
- Female patients who is pregnant, lactating, plans to become pregnant, or with child-bearing potential without contraception.
- Simultaneously participating in another investigational drug or device study or use of any investigational drug(s) or therapeutic device(s) within 3 months preceding enrollment
- Has been treated with an investigational device, drug, or procedure for UAB within the last 3 months.
- History of cancer in pelvic organs, ureters, or kidneys or any cancer that has undergone treatment within the past 12 months.
- Medical condition or disorder that may limit life expectancy or that may cause protocol deviations (e.g. unable to perform self-evaluations/accurately report medical history, and/or urinary symptoms).
- History of spinal cord injury affecting urinary function.
Show all 18Show fewer
- Patients with uncontrolled acute urinary tract infection. An active urinary tract infection as evidenced by positive urine culture at the time of baseline assessment. If a UTI is confirmed in the baseline sample (e.g., positive urine culture containing > 100,000 cfu/mL in midstream urine), the run-in period should be stopped. After successful treatment of the UTI, the patient can be rescreened and if eligible enroll in the study. If the patient has asymptomatic bacteriuria (i.e., a positive urine culture without clinical signs and symptoms of a UTI), the patient should not be excluded.
- Currently taking medication(s) that may affect urination, including prescription drugs (i.e. anticholinergics, tricyclic antidepressants, bethanechol), over the counter drugs, dietary and/or herbal supplements, adrenergic antagonists. Alpha adrenergic blockers are allowed to use in a stable condition (longer than 1 month and keeping use during the study period).
- Pelvic organ prolapses beyond the introitus (e.g., cystocele, rectocele).
- Prior mesh surgery for stress urinary incontinence or pelvic prolapse.
- Any other condition which per investigators' judgement, may affect the patient's safety (e.g. significant cardiovascular disease, asthma or other breathing disorders).
- Patients with bladder outlet obstruction on enrollment.
- Patients with any contraindication to be urethral catheterization during diagnostic test or treatment or follow-up period.
- Patients have laboratory abnormalities at screening including:
- ALT > 3 x upper limit of normal range AST > 3 x upper limit of normal range Serum creatinine level > 2 x upper limit of normal range.
- Patients with any other serious disease considered by the investigator not in the condition to enter the trial.
- Patients with cortisone treatment 6 week before first LESW therapy.
- Other single item of Lab examination also can be retested per Investigator's discretion if abnormality. Patient will be rescreened and randomized into the study once confirmed eligible.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Chang Gung Memorial Hospital, Chang Gung University College of Medicine
Kaohsiung City, 833
About this study
Official title: Extracoporeal Shock Wave Therapy (ESWT) for the Treatment of Detrusor Underactivity/ Underactive Bladder (DU/UAB) - a Single Center, Randomized, Double-blind, Placebo-controlled, Prospective Study
To evaluate the efficacy and safety of ESWT for the treatment of patients with DU/UAB
Read the detailed description
The prevalence of detrusor underactivity/ underactive bladder (DU/UAB) increased with age, which is 9-28% in young men (<50 years), and is up to 48% in the elderly men (>70 years) with non-neurogenic lower urinary tract symptoms. In women aged >70 years, the prevalence of DU ranged from 12% to 45%. Currently, there is a lack of effective pharmacological or surgical treatment of DU/UAB. Previously we demonstrated that extracoporeal shock wave therapy (ESWT) was able to mediate a partial recovery in the contractility of cryoinjury induced DU/UAB model in rats. Wang et al. reported the therapeutic effect of ESWT in the streptozotocin induced diabetic underactive bladder rat model with significantly improved voiding function, enhanced detrusor contractility, increased muscle actin expression and muscle proportion of the bladder wall, and recovery of neuronal integrity and innervations. Taken together, these findings suggest that a potential clinical benefit of ESWT treatment for patients with DU/UAB.
A total of 60 patients with DU/UAB will be enrolled to receive ESWT once a week for 6 weeks or placebo treatment. Patients with DU/UAB symptoms with post void residual (PVR) ≥ 100 mL and proven of DU/UAB without bladder outlet obstruction (BOO) by urodynamic study. Patients should not have uncontrolled acute urinary tract infection, and should not have treated with an investigational device, drug, or procedure for UAB within the last 3 months. Retreatment with ESWT at 3 months if patient reports ineffective will be allowed.
Primary end-point is the change of PVR volume (mL) from baseline to 1 month after treatment. Secondary endpoints include daily frequency, nocturia and FBC as record in 3-day voiding diary, Qmax, Pdet@Qmax, voided volume, PVR and global response assessment (GRA). One visit is required at baseline screening (before first treatment), treatment 1 (V1), treatment 2 (V2), treatment 3 (V3), treatment 4 (V4), treatment 5 (V5), treatment 6 (V6) and 1 month post V6 treatment (V7, primary end-point), and 3 months post V6 treatment (V8). Urine samples will be collected at each time-point for NGF and cytokines tests. Cystoscopy bladder biopsy will be performed at baseline and at 3 months post treatment, optional.
- Conditions
- Detrusor, Underactive, Detrusor Underactivity
- Being tested
- Extracoporeal shock wave therapy, Placebo
- Keywords
- shock wave, detrusor underactivity, underactive bladder
- Medical subject headings
- Urinary Bladder, Underactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracoporeal shock wave therapyDevice
Probe be transcutaneous applied to the region of bladder dome, right upper lateral wall, right lower lateral wall, left upper lateral wall, and left lower lateral wall with 2500 shocks, frequency of 4 pulses per second and maximum total energy flow density 0.25 millijoule/mm2 once a week for 6 weeks
PlaceboDevice
Probe be transcutaneous applied to the region of bladder dome, right upper lateral wall, right lower lateral wall, left upper lateral wall, and left lower lateral wall with 2500 shocks, frequency of 4 pulses per second but no energy once a week for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo treatment (shock wave probe w/o energy) Receives: Device: Placebo |
| Extracoporeal shock wave therapy | Experimental | Extracoporeal shock wave therapy (shock wave probe w/ energy) Receives: Device: Extracoporeal shock wave therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Net changes of the mean post void residual (PVR) volume (mL) from baseline to 1 month after the last treatment day
Net changes of the PVR from baseline to 1 month after the last treatment day (higher PVR volumes represent a worse outcome)
Measured: Baseline and 1 month
Secondary outcomes (8)
Net changes of the functional bladder capacity (FBC) as assessed by the maximum urine volume (milliliters) as recorded in 3-day voiding diary
Net changes of the functional bladder capacity (FBC) from baseline to 1 month after the last treatment day (higher FBC volumes represent a better outcome)
Measured: Baseline and 1 month
Net changes of the Global response assessment (GRA)
Global response assessment (GRA) of therapeutic result by the patient (categorized from -3 to +3, indicating markedly worse to markedly improved) at 1 month after the last treatment day
Measured: Baseline and 1 month
Net changes of the maximum flow rate
Net changes of the maximum flow rate from baseline to 1 month after the last treatment day (higher maximum flow rate represent a better outcome)
Measured: Baseline and 1 month
Net changes of the voided volume
Net changes of the voided volume from baseline to 1 month after the last treatment day (higher voided volumes represent a better outcome)
Measured: Baseline and 1 month
Net changes of the Pdet@Qmax
Net changes of the Pdet@Qmax from baseline to 1 month after the last treatment day
Measured: Baseline and 1 month
Net changes of the postvoid residual volume
Net changes of the postvoid residual volume from baseline to 1 month after the last treatment day (lower postvoid residual volume represent a better outcome)
Measured: Baseline and 1 month
Changes of the Underactive Bladder Questionnaire (UAB-Q) score
Changes of the UAB-Q score from baseline to 1 month after the last treatment day (lower UAB-Q score represent a better outcome)
Measured: Baseline and 1 month
Changes of urinary nerve growth factor and cytokines level
Changes of the urinary nerve growth factor and cytokines level from baseline to 1 month after the last treatment day
Measured: Baseline and 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study start15 Oct 2019
- Primary completion1 Dec 2021
- Study completion10 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Detrusor, UnderactiveStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blind, placebo control study. Eligible patients will be assigned a randomization number in sequential order and each of the randomization will determine the allocation of one of the two treatment groups (ESWT and Placebo) in 1: 1 ratio as shown below. The ESWT and placebo will be controlled by a research assistance who will not evaluate the therapeutic outcome to ensure the double-blind method.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tsang-Tang Hsieh, MD, Study chair, Institutional Review Board Chang Gung Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04161183
- Sponsor's protocol ID
- 201900500A0
- Status last verified
- Mar 2022
- First submitted
- 10 Nov 2019
- Last updated
- 5 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-committee of the International Continence Society. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn. 2002;21(2):167-78. doi: 10.1002/nau.10052. No abstract available.
PubMed 11857671Miyazato M, Yoshimura N, Chancellor MB. The other bladder syndrome: underactive bladder. Rev Urol. 2013;15(1):11-22.
PubMed 23671401Chuang YC, Plata M, Lamb LE, Chancellor MB. Underactive Bladder in Older Adults. Clin Geriatr Med. 2015 Nov;31(4):523-33. doi: 10.1016/j.cger.2015.06.002. Epub 2015 Jul 26.
PubMed 26476113Osman NI, Chapple CR, Abrams P, Dmochowski R, Haab F, Nitti V, Koelbl H, van Kerrebroeck P, Wein AJ. Detrusor underactivity and the underactive bladder: a new clinical entity? A review of current terminology, definitions, epidemiology, aetiology, and diagnosis. Eur Urol. 2014 Feb;65(2):389-98. doi: 10.1016/j.eururo.2013.10.015. Epub 2013 Oct 26.
PubMed 24184024Brierly RD, Hindley RG, McLarty E, Harding DM, Thomas PJ. A prospective controlled quantitative study of ultrastructural changes in the underactive detrusor. J Urol. 2003 Apr;169(4):1374-8. doi: 10.1097/01.ju.0000055781.07630.aa.
PubMed 12629365Elbadawi A, Yalla SV, Resnick NM. Structural basis of geriatric voiding dysfunction. II. Aging detrusor: normal versus impaired contractility. J Urol. 1993 Nov;150(5 Pt 2):1657-67. doi: 10.1016/s0022-5347(17)35867-6.
PubMed 8411454Jiang YH, Kuo HC. Urothelial Barrier Deficits, Suburothelial Inflammation and Altered Sensory Protein Expression in Detrusor Underactivity. J Urol. 2017 Jan;197(1):197-203. doi: 10.1016/j.juro.2016.07.071. Epub 2016 Jul 17.
PubMed 27436428Cho KJ, Koh JS, Choi J, Kim JC. Changes in Adenosine Triphosphate and Nitric Oxide in the Urothelium of Patients with Benign Prostatic Hyperplasia and Detrusor Underactivity. J Urol. 2017 Dec;198(6):1392-1396. doi: 10.1016/j.juro.2017.06.080. Epub 2017 Jun 24.
PubMed 28655527Andersson KE. Detrusor underactivity/underactive bladder: new research initiatives needed. J Urol. 2010 Nov;184(5):1829-30. doi: 10.1016/j.juro.2010.08.048. Epub 2010 Sep 17. No abstract available.
PubMed 20846686Osman NI, Esperto F, Chapple CR. Detrusor Underactivity and the Underactive Bladder: A Systematic Review of Preclinical and Clinical Studies. Eur Urol. 2018 Nov;74(5):633-643. doi: 10.1016/j.eururo.2018.07.037. Epub 2018 Aug 20.
PubMed 30139634Wang HJ, Cheng JH, Chuang YC. Potential applications of low-energy shock waves in functional urology. Int J Urol. 2017 Aug;24(8):573-581. doi: 10.1111/iju.13403. Epub 2017 Jul 11.
PubMed 28697536Chuang YC, Tyagi P, Wang HJ, Huang CC, Lin CC, Chancellor MB. Urodynamic and molecular characteristics of detrusor underactivity in a rat cryoinjury model and effects of low energy shock wave therapy. Neurourol Urodyn. 2018 Feb;37(2):708-715. doi: 10.1002/nau.23381. Epub 2017 Aug 2.
PubMed 28767169Chuang YC, Tyagi P, Luo HL, Lee WC, Wang HJ, Huang CC, Chancellor MB. Long-term functional change of cryoinjury-induced detrusor underactivity and effects of extracorporeal shock wave therapy in a rat model. Int Urol Nephrol. 2019 Apr;51(4):617-626. doi: 10.1007/s11255-019-02095-4. Epub 2019 Feb 22.
PubMed 30796726Wang HS, Oh BS, Wang B, Ruan Y, Zhou J, Banie L, Lee YC, Tamaddon A, Zhou T, Wang G, Lin G, Lue TF. Low-intensity extracorporeal shockwave therapy ameliorates diabetic underactive bladder in streptozotocin-induced diabetic rats. BJU Int. 2018 Sep;122(3):490-500. doi: 10.1111/bju.14216. Epub 2018 Apr 20.
PubMed 29603534Zissler A, Steinbacher P, Zimmermann R, Pittner S, Stoiber W, Bathke AC, Sanger AM. Extracorporeal Shock Wave Therapy Accelerates Regeneration After Acute Skeletal Muscle Injury. Am J Sports Med. 2017 Mar;45(3):676-684. doi: 10.1177/0363546516668622. Epub 2016 Oct 13.
PubMed 27729321
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extracoporeal Shock Wave Therapy (ESWT) for the Treatment of Detrusor Underactivity/ Underactive Bladder (DU/UAB) - a Single Center, Randomized, Double-blind, Placebo-controlled, Prospective Study
- ClinicalTrials.gov ID
- NCT04161183
- Acronym / sponsor ID
- 201900500A0
- Conditions
- Detrusor, Underactive, Detrusor Underactivity
- Keywords
- shock wave, detrusor underactivity, underactive bladder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 10 Aug 2022 (actual)
- First posted
- 13 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy and safety of ESWT for the treatment of patients with DU/UAB
Detailed description
The prevalence of detrusor underactivity/ underactive bladder (DU/UAB) increased with age, which is 9-28% in young men (<50 years), and is up to 48% in the elderly men (>70 years) with non-neurogenic lower urinary tract symptoms. In women aged >70 years, the prevalence of DU ranged from 12% to 45%. Currently, there is a lack of effective pharmacological or surgical treatment of DU/UAB. Previously we demonstrated that extracoporeal shock wave therapy (ESWT) was able to mediate a partial recovery in the contractility of cryoinjury induced DU/UAB model in rats. Wang et al. reported the therapeutic effect of ESWT in the streptozotocin induced diabetic underactive bladder rat model with significantly improved voiding function, enhanced detrusor contractility, increased muscle actin expression and muscle proportion of the bladder wall, and recovery of neuronal integrity and innervations. Taken together, these findings suggest that a potential clinical benefit of ESWT treatment for patients with DU/UAB.
A total of 60 patients with DU/UAB will be enrolled to receive ESWT once a week for 6 weeks or placebo treatment. Patients with DU/UAB symptoms with post void residual (PVR) ≥ 100 mL and proven of DU/UAB without bladder outlet obstruction (BOO) by urodynamic study. Patients should not have uncontrolled acute urinary tract infection, and should not have treated with an investigational device, drug, or procedure for UAB within the last 3 months. Retreatment with ESWT at 3 months if patient reports ineffective will be allowed.
Primary end-point is the change of PVR volume (mL) from baseline to 1 month after treatment. Secondary endpoints include daily frequency, nocturia and FBC as record in 3-day voiding diary, Qmax, Pdet@Qmax, voided volume, PVR and global response assessment (GRA). One visit is required at baseline screening (before first treatment), treatment 1 (V1), treatment 2 (V2), treatment 3 (V3), treatment 4 (V4), treatment 5 (V5), treatment 6 (V6) and 1 month post V6 treatment (V7, primary end-point), and 3 months post V6 treatment (V8). Urine samples will be collected at each time-point for NGF and cytokines tests. Cystoscopy bladder biopsy will be performed at baseline and at 3 months post treatment, optional.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Double blind, placebo control study. Eligible patients will be assigned a randomization number in sequential order and each of the randomization will determine the allocation of one of the two treatment groups (ESWT and Placebo) in 1: 1 ratio as shown below. The ESWT and placebo will be controlled by a research assistance who will not evaluate the therapeutic outcome to ensure the double-blind method.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Device: PlaceboPlacebo treatment (shock wave probe w/o energy) |
| Extracoporeal shock wave therapy | Experimental | Device: Extracoporeal shock wave therapyExtracoporeal shock wave therapy (shock wave probe w/ energy) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Adult male or female, at least 20 years of age.
- History of UAB (defined as bothersome chronic incomplete bladder emptying) for at least 3 months documented in the medical record with recurring UAB symptoms.
- No UAB symptom relief (unresponsiveness) with previous used medications and/or other treatments.
- Voiding difficulty (complains of difficulty emptying the bladder).
- UAB consistent with diabetes, MS, Parkinson's disease, or aging idiopathic.
Key exclusion criteria (18 listed)
- Female patients who is pregnant, lactating, plans to become pregnant, or with child-bearing potential without contraception.
- Simultaneously participating in another investigational drug or device study or use of any investigational drug(s) or therapeutic device(s) within 3 months preceding enrollment
- Has been treated with an investigational device, drug, or procedure for UAB within the last 3 months.
- History of cancer in pelvic organs, ureters, or kidneys or any cancer that has undergone treatment within the past 12 months.
- Medical condition or disorder that may limit life expectancy or that may cause protocol deviations (e.g. unable to perform self-evaluations/accurately report medical history, and/or urinary symptoms).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extracoporeal shock wave therapyProbe be transcutaneous applied to the region of bladder dome, right upper lateral wall, right lower lateral wall, left upper lateral wall, and left lower lateral wall with 2500 shocks, frequency of 4 pulses per second and maximum total energy flow density 0.25 millijoule/mm2 once a week for 6 weeks | Device | Extracoporeal shock wave therapy |
| PlaceboProbe be transcutaneous applied to the region of bladder dome, right upper lateral wall, right lower lateral wall, left upper lateral wall, and left lower lateral wall with 2500 shocks, frequency of 4 pulses per second but no energy once a week for 6 weeks | Device | Placebo |
Primary outcome
Net changes of the mean post void residual (PVR) volume (mL) from baseline to 1 month after the last treatment day
Time frame: Baseline and 1 month
Net changes of the PVR from baseline to 1 month after the last treatment day (higher PVR volumes represent a worse outcome)
8 secondary outcomes
Net changes of the functional bladder capacity (FBC) as assessed by the maximum urine volume (milliliters) as recorded in 3-day voiding diary
Time frame: Baseline and 1 month
Net changes of the Global response assessment (GRA)
Time frame: Baseline and 1 month
Net changes of the maximum flow rate
Time frame: Baseline and 1 month
Net changes of the voided volume
Time frame: Baseline and 1 month
Net changes of the Pdet@Qmax
Time frame: Baseline and 1 month
Net changes of the postvoid residual volume
Time frame: Baseline and 1 month
Changes of the Underactive Bladder Questionnaire (UAB-Q) score
Time frame: Baseline and 1 month
Changes of urinary nerve growth factor and cytokines level
Time frame: Baseline and 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2022.
- Background: PubMed 11857671Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-committee of the International Continence Society. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn. 2002;21(2):167-78. doi: 10.1002/nau.10052. No abstract available.
- Background: PubMed 23671401Miyazato M, Yoshimura N, Chancellor MB. The other bladder syndrome: underactive bladder. Rev Urol. 2013;15(1):11-22.
- Background: PubMed 26476113Chuang YC, Plata M, Lamb LE, Chancellor MB. Underactive Bladder in Older Adults. Clin Geriatr Med. 2015 Nov;31(4):523-33. doi: 10.1016/j.cger.2015.06.002. Epub 2015 Jul 26.
- Background: PubMed 24184024Osman NI, Chapple CR, Abrams P, Dmochowski R, Haab F, Nitti V, Koelbl H, van Kerrebroeck P, Wein AJ. Detrusor underactivity and the underactive bladder: a new clinical entity? A review of current terminology, definitions, epidemiology, aetiology, and diagnosis. Eur Urol. 2014 Feb;65(2):389-98. doi: 10.1016/j.eururo.2013.10.015. Epub 2013 Oct 26.
- Background: PubMed 12629365Brierly RD, Hindley RG, McLarty E, Harding DM, Thomas PJ. A prospective controlled quantitative study of ultrastructural changes in the underactive detrusor. J Urol. 2003 Apr;169(4):1374-8. doi: 10.1097/01.ju.0000055781.07630.aa.
- Background: PubMed 8411454Elbadawi A, Yalla SV, Resnick NM. Structural basis of geriatric voiding dysfunction. II. Aging detrusor: normal versus impaired contractility. J Urol. 1993 Nov;150(5 Pt 2):1657-67. doi: 10.1016/s0022-5347(17)35867-6.
- Background: PubMed 27436428Jiang YH, Kuo HC. Urothelial Barrier Deficits, Suburothelial Inflammation and Altered Sensory Protein Expression in Detrusor Underactivity. J Urol. 2017 Jan;197(1):197-203. doi: 10.1016/j.juro.2016.07.071. Epub 2016 Jul 17.
- Background: PubMed 28655527Cho KJ, Koh JS, Choi J, Kim JC. Changes in Adenosine Triphosphate and Nitric Oxide in the Urothelium of Patients with Benign Prostatic Hyperplasia and Detrusor Underactivity. J Urol. 2017 Dec;198(6):1392-1396. doi: 10.1016/j.juro.2017.06.080. Epub 2017 Jun 24.
- Background: PubMed 20846686Andersson KE. Detrusor underactivity/underactive bladder: new research initiatives needed. J Urol. 2010 Nov;184(5):1829-30. doi: 10.1016/j.juro.2010.08.048. Epub 2010 Sep 17. No abstract available.
- Background: PubMed 30139634Osman NI, Esperto F, Chapple CR. Detrusor Underactivity and the Underactive Bladder: A Systematic Review of Preclinical and Clinical Studies. Eur Urol. 2018 Nov;74(5):633-643. doi: 10.1016/j.eururo.2018.07.037. Epub 2018 Aug 20.
- Background: PubMed 28697536Wang HJ, Cheng JH, Chuang YC. Potential applications of low-energy shock waves in functional urology. Int J Urol. 2017 Aug;24(8):573-581. doi: 10.1111/iju.13403. Epub 2017 Jul 11.
- Background: PubMed 28767169Chuang YC, Tyagi P, Wang HJ, Huang CC, Lin CC, Chancellor MB. Urodynamic and molecular characteristics of detrusor underactivity in a rat cryoinjury model and effects of low energy shock wave therapy. Neurourol Urodyn. 2018 Feb;37(2):708-715. doi: 10.1002/nau.23381. Epub 2017 Aug 2.
- Astellas Pharma Inc (Astellas Pharma Europe B.V.). A Study of ASP8302 in Participants With Underactive Bladder. ClinicalTrials.gov Identifier: NCT03702777Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tsang-Tang Hsieh, MD study chair
Institutional Review Board Chang Gung Medical Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracoporeal shock wave therapy in people with Detrusor, Underactive and Detrusor Underactivity, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Net changes of the mean post void residual (PVR) volume (mL) from baseline to 1 month after the last treatment day (time frame: Baseline and 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04161183, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2022.