The Treatment Efficacy of Prolotherapy in Bladder Voiding Dysfunction

Overactive Bladder Clinical Trial

Official title:

The Treatment Efficacy of Prolotherapy in Bladder Voiding Dysfunction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05485142
• Other study ID #: 108B01
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: June 30, 2024

Study information

• Verified date: August 2023
• Source: Taichung Armed Forces General Hospital
• Contact: Jing-dung Shen, MD
• Phone: +886958878129
• Email: jdwhydo[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Voiding dysfunction including overactive bladder, underactive bladder, and neuropathic bladder. Voiding dysfunction has a great impact on life quality, especially in the elderly society. The current medication for overactive bladder has limited efficacy and the patient easily to dropout the medication because of its side-effects. The underactive bladder is a new entity of voiding dysfunction, its optimal is still unknown. Sacral neuromodulation(SNM) and posterior tibial nerve stimulation(PTNS) have been applied for both overactive bladder and underactive bladder treatment and the results is promising, but the equipment of SNM or PTNS is not available in most places. Prolotherapy using glucose local injection causing inflammatory reaction to stimulate cytokine and growth factors release. Investigators combined the concepts of posterior tibial nerve stimulation and prolotherapy to treat voiding dysfunction. Investigators anticipate it maybe a new promising treatment for voiding dysfunction.

Description:

Inclusion criteria:1. Adults over 20 years-old. 2. The patient who meets the diagnostic criteria of overactive bladder or underactive bladder. 3. The patient who capable to complete 3-days voiding diary and the questionnaire. Exclusion criteria: 1. The patient has severe stress urinary incontinence, severe pelvic organ prolapse, acute urinary tract infection, urolithiasis, or urinary tract malignancy. 2. The patient who has active skin disease on legs or not suitable for leg local injection. 3. Pregnant women. Method: 40 overactive bladder patients and 40 underactive bladder patients. The patients will receive 5% glucose 10ml local injection peripheral to posterior tibial nerve near ankle under ultrasound guidance once a week for 4 weeks, then the patients will be followed up once-a-month for 3 months. OverActive Bladder Symptom Score(OABSS), Core Lower Urinary Tract Symptom score(CLSS) questionnaire, 3-days voiding diary, and urine nerve growth factor are used for assessment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. Adults over 20 years-old.

2. The patient who meets the diagnostic criteria of overactive bladder or underactive bladder.

3. The patient who capable to complete 3-days voiding diary and the questionnaire.

Exclusion Criteria:

1. Severe stress urinary incontinence or severe pelvic organ prolapse.

2. Acute urinary tract infection.

3. Active hematuria, urolithiasis, or neoplasm of urinary tract.

4. Acute skin lesion over the ankle injection site or the patient who could not tolerate ankle injection.

5. Pregnant women.

Related Conditions & MeSH terms

• Overactive Bladder
• Underactive Bladder
• Urinary Bladder, Overactive
• Urinary Bladder, Underactive

Intervention

Procedure:
• prolotherapy
5% glucose 10ml local injection peripheral to posterior tibial nerve near ankle under ultrasound guidance once a week for 4 weeks.

Locations

Country	Name	City	State
Taiwan	Taichung Armed Forces General Hospital	Taichung	Other (Non US)

Sponsors (1)

Lead Sponsor	Collaborator
Taichung Armed Forces General Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (13)

Abraham TS, Chen ML, Ma SX. TRPV1 expression in acupuncture points: response to electroacupuncture stimulation. J Chem Neuroanat. 2011 Apr;41(3):129-36. doi: 10.1016/j.jchemneu.2011.01.001. Epub 2011 Jan 20. — View Citation

Chen HC, Chen MY, Hsieh CL, Wu SY, Hsu HC, Lin YW. TRPV1 is a Responding Channel for Acupuncture Manipulation in Mice Peripheral and Central Nerve System. Cell Physiol Biochem. 2018;49(5):1813-1824. doi: 10.1159/000493627. Epub 2018 Sep 19. — View Citation

Fowler CJ, Griffiths D, de Groat WC. The neural control of micturition. Nat Rev Neurosci. 2008 Jun;9(6):453-66. doi: 10.1038/nrn2401. — View Citation

Gormley EA, Lightner DJ, Faraday M, Vasavada SP; American Urological Association; Society of Urodynamics, Female Pelvic Medicine. Diagnosis and treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU guideline amendment. J Urol. 2015 May;193( — View Citation

Kaptchuk TJ. Acupuncture: theory, efficacy, and practice. Ann Intern Med. 2002 Mar 5;136(5):374-83. doi: 10.7326/0003-4819-136-5-200203050-00010. — View Citation

MacDiarmid SA, Peters KM, Shobeiri SA, Wooldridge LS, Rovner ES, Leong FC, Siegel SW, Tate SB, Feagins BA. Long-term durability of percutaneous tibial nerve stimulation for the treatment of overactive bladder. J Urol. 2010 Jan;183(1):234-40. doi: 10.1016/ — View Citation

Peters KM, Carrico DJ, Perez-Marrero RA, Khan AU, Wooldridge LS, Davis GL, Macdiarmid SA. Randomized trial of percutaneous tibial nerve stimulation versus Sham efficacy in the treatment of overactive bladder syndrome: results from the SUmiT trial. J Urol. — View Citation

Sakura S, Chan VW, Ciriales R, Drasner K. The addition of 7.5% glucose does not alter the neurotoxicity of 5% lidocaine administered intrathecally in the rat. Anesthesiology. 1995 Jan;82(1):236-40. doi: 10.1097/00000542-199501000-00028. — View Citation

Tsui BC, Kropelin B, Ganapathy S, Finucane B. Dextrose 5% in water: fluid medium for maintaining electrical stimulation of peripheral nerves during stimulating catheter placement. Acta Anaesthesiol Scand. 2005 Nov;49(10):1562-5. doi: 10.1111/j.1399-6576.2 — View Citation

Tsui BCH, Kropelin B. The electrophysiological effect of dextrose 5% in water on single-shot peripheral nerve stimulation. Anesth Analg. 2005 Jun;100(6):1837-1839. doi: 10.1213/01.ANE.0000153020.84780.A5. — View Citation

Wu YT, Ho TY, Chou YC, Ke MJ, Li TY, Tsai CK, Chen LC. Six-month Efficacy of Perineural Dextrose for Carpal Tunnel Syndrome: A Prospective, Randomized, Double-Blind, Controlled Trial. Mayo Clin Proc. 2017 Aug;92(8):1179-1189. doi: 10.1016/j.mayocp.2017.05 — View Citation

Zhang T, Yu J, Huang Z, Wang G, Zhang R. Electroacupuncture improves neurogenic bladder dysfunction through activation of NGF/TrkA signaling in a rat model. J Cell Biochem. 2019 Jun;120(6):9900-9905. doi: 10.1002/jcb.28272. Epub 2018 Dec 28. — View Citation

Zhao Y, Zhou J, Mo Q, Wang Y, Yu J, Liu Z. Acupuncture for adults with overactive bladder: A systematic review and meta-analysis of randomized controlled trials. Medicine (Baltimore). 2018 Feb;97(8):e9838. doi: 10.1097/MD.0000000000009838. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The improvement of Patient Perception of Bladder Condition (PPBC)	The PPBC measures the patients' perception of their urinary (bladder) problems. Ranged from 1 to 6. The core 1 means no bother from bladder condition, higher score means more bother form bladder condition.	Week 0
Other	The improvement of Patient Perception of Bladder Condition	The PPBC measures the patients' perception of their urinary (bladder) problems. Ranged from 1 to 6. The core 1 means no bother from bladder condition, higher score means more bother form bladder condition.	Week1
Other	The improvement of Patient Perception of Bladder Condition	The PPBC measures the patients' perception of their urinary (bladder) problems. Ranged from 1 to 6. The core 1 means no bother from bladder condition, higher score means more bother form bladder condition.	Week2
Other	The improvement of Patient Perception of Bladder Condition	The PPBC measures the patients' perception of their urinary (bladder) problems. Ranged from 1 to 6. The core 1 means no bother from bladder condition, higher score means more bother form bladder condition.	Week3
Other	The improvement of Patient Perception of Bladder Condition	The PPBC measures the patients' perception of their urinary (bladder) problems. Ranged from 1 to 6. The core 1 means no bother from bladder condition, higher score means more bother form bladder condition.	Week4
Other	The improvement of Patient Perception of Bladder Condition	The PPBC measures the patients' perception of their urinary (bladder) problems.	Week8
Other	The improvement of Patient Perception of Bladder Condition	The PPBC measures the patients' perception of their urinary (bladder) problems. Ranged from 1 to 6. The core 1 means no bother from bladder condition, higher score means more bother form bladder condition.	Week12
Other	The improvement of Patient Perception of Bladder Condition	The PPBC measures the patients' perception of their urinary (bladder) problems. Range from 1 to 6. The core 1 means no bother from bladder condition, higher score means more bother form bladder condition.	Week16
Primary	Overactive Bladder Symptom Score	The improvement of overactive bladder symptom score (OABSS), OABSS ranged from 0 to 15, the higher score means more severity of overactive bladder.	Week 0
Primary	Overactive Bladder Symptom Score	The improvement of overactive bladder symptom score (OABSS), OABSS ranged from 0 to 15, the higher score means more severity of overactive bladder.	Week1
Primary	Overactive Bladder Symptom Score	The improvement of overactive bladder symptom score (OABSS), OABSS ranged from 0 to 15, the higher score means more severity of overactive bladder.	Week2
Primary	Overactive Bladder Symptom Score	The improvement of overactive bladder symptom score (OABSS), OABSS ranged from 0 to 15, the higher score means more severity of overactive bladder.	Week3
Primary	Overactive Bladder Symptom Score	The improvement of overactive bladder symptom score (OABSS), OABSS ranged from 0 to 15, the higher score means more severity of overactive bladder.	Week4
Primary	Overactive Bladder Symptom Score	The improvement of overactive bladder symptom score (OABSS), OABSS ranged from 0 to 15, the higher score means more severity of overactive bladder.	Week8
Primary	Overactive Bladder Symptom Score	The improvement of overactive bladder symptom score (OABSS), OABSS ranged from 0 to 15, the higher score means more severity of overactive bladder.	Week12
Primary	Overactive Bladder Symptom Score	The improvement of overactive bladder symptom score (OABSS), OABSS ranged from 0 to 15, the higher score means more severity of overactive bladder.	Week16
Secondary	Cystometric bladder capacity	Cystometric bladder capacity: the volume of water instilled into bladder while performing cystometry examination.	Week0
Secondary	Cystometric bladder capacity	Cystometric bladder capacity: the volume of water instilled into bladder while performing cystometry examination.	Week4
Secondary	Cystometric bladder capacity	Cystometric bladder capacity: the volume of water instilled into bladder while performing cystometry examination.	Week16