Intravesical Injection of Dextrose to Improve Lower Urinary Tract Symptoms Caused by Chronic Cystitis

NCT ID: NCT04821882

Last Updated: 2021-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-01
• Study Completion Date: 2020-10-11

Brief Summary

The pathogenesis of bladder pain syndrome/interstitial cystitis (BPS/IC) is currently unclear. Scholars have put forward different hypotheses, including the function of the extracellular matrix surface of the glycosaminoglycan (GAG) layer, downregulation of tight junction protein, increased urothelial permeability, mast cell activation, neurogenic inflammation, and psychosomatic factors. The symptoms are very similar to severe bladder pain syndrome/interstitial cystitis, and the patients respond to existing medications. In 1956, Dr. George Hackett created a method for treating damaged ligaments and tendons called prolotherapy (proliferation therapy). Prolotherapy is defined as an alternative therapy for musculoskeletal and arthritic pain, including the treatment of irritating substances (such as dextrose, also known as d-glucose) injected into ligaments or tendons to promote the growth of new tissues. There are many clinical trials confirming that proliferation therapy can effectively treat painful musculoskeletal problems. For example, in patients with lateral epicondylitis treated with a solution with a final concentration of 10% dextrose, compared with patients treated with placebo (normal saline), pain and isometric muscle strength improved significantly. A recent literature review also tells that hypertonic glucose proliferation therapy can effectively treat a variety of musculoskeletal diseases.

Hence, this research suggests that dextrose prolotherapy is an affordable and effective pain management strategy in dealing with musculoskeletal neuroinflammation pain in BPS/IC. In order to begin to understand prolotherapy and its therapeutic utility, this study should begin to elucidate the immediate response of prolotherapy in the urology field by investigating the impact of dextrose.

This project is expected to accommodate subjects with BPS/IC, by injecting 10% dextrose into the bladder lining muscles of IC patients and performing various urodynamic tests and questionnaires to evaluate the patient's urinary voiding symptoms and urinary bladder function recovery. Afterward, the expressions of growth factors and cytokines in the urine samples were investigated in an attempt to reveal the mechanism of dextrose prolotherapy in BPS/IC disease.

Detailed Description

This project treated 29 male and female subjects (aged over 20 years) with BPS/IC and other chronic inflammation of the bladder. The enrolled subjects were collected from May 2019 to October 2020. The subjects were given intravesical injections of 10% dextrose under intravenous general anesthesia in the operating room: 2 mL of 50% Dextrose (Vitagen Inj., Taiwan Biotech co. ltd., Taipei, Taiwan) was briefly diluted with 10 mL of normal saline and 11 sub urothelial injections (1 mL each site) were performed. The injection needle was inserted into the urothelium at the trigone (1 site), the posterior (6 sites), and the lateral walls (4 sites) of the bladder, using a 23-gauge needle under rigid cystoscopic injection instrument (22-Fr; Knittlingen, Richard Wolf, Germany). No post-injection analgesics were provided to patients. Treatment was repeated based on the patients' condition once every 2 weeks for the first 6 cycles and once every month for the remaining 3 cycles with a maximum of 9 planned therapy cycles up to 6 months. The patients would be followed-up and assessed at each treatment time and up to 1 month after the last treatment. 19 health subjects were also recruited as a healthy control as the comparison.

Conditions

Bladder Pain Syndrome; Interstitial Cystitis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

Healthy participant

Group Type: NO_INTERVENTION

No interventions assigned to this group

Dextrose treatment

IC/PBS patients had been treated by intravesical instillations of hyaluronic acid and/or botox for more than 6 months

Group Type: EXPERIMENTAL

Dextrose

Intervention Type: DRUG

10% dextrose: 2 mL of 50% dextrose in 10 mL normal saline and injected by 11 sub urothelial injections

Interventions

Dextrose

10% dextrose: 2 mL of 50% dextrose in 10 mL normal saline and injected by 11 sub urothelial injections

Intervention Type: DRUG

Other Intervention Names

Vitagen Inj., Taiwan Biotech Co., Ltd., Taipei, Taiwan

Eligibility Criteria

Inclusion Criteria

1. The subject is aged over 20 years old.

2. The subject was diagnosed as bladder pain syndrome/interstitial cystitis subject with lower urinary tract symptoms, such as frequent urination, urgent urination, bladder pain, etc.

Exclusion Criteria

1. The subject is aged under 20 years old.

2. Pregnant women.

3. The subject with congenital disorders of the urinary tract.

4. The subject with a urinary tract infection or tumor.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Defense Medical Center, Taiwan

OTHER

Sponsor Role: lead

Responsible Party

Juin-Hong Cherng

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

National Defense of Medical Center, Tri-Service General Hospital

Taipei, , Taiwan

Countries

Taiwan

References

Meng E, Hsu YC, Chuang YC. Advances in intravesical therapy for bladder pain syndrome (BPS)/interstitial cystitis (IC). Low Urin Tract Symptoms. 2018 Jan;10(1):3-11. doi: 10.1111/luts.12214.

Reference Type: BACKGROUND

PMID: 29341502 (View on PubMed)

Hanno PM. Campbell-Walsh Urology. In: Wein AJ, Kavoussi LR, Partin AW, Peters C, editors. Bladder pain syndrome (interstitial cystitis) and related disorder. 1. Eleventh edition. ed. Philadelphia. PA: Elsevier. 2016; p. 334-70.

Reference Type: BACKGROUND

Middela S, Pearce I. Ketamine-induced vesicopathy: a literature review. Int J Clin Pract. 2011 Jan;65(1):27-30. doi: 10.1111/j.1742-1241.2010.02502.x.

Reference Type: BACKGROUND

PMID: 21155941 (View on PubMed)

Tsai TH, Cha TL, Lin CM, Tsao CW, Tang SH, Chuang FP, Wu ST, Sun GH, Yu DS, Chang SY. Ketamine-associated bladder dysfunction. Int J Urol. 2009 Oct;16(10):826-9. doi: 10.1111/j.1442-2042.2009.02361.x. Epub 2009 Jul 29.

Reference Type: BACKGROUND

PMID: 19659678 (View on PubMed)

Chu PS, Ma WK, Wong SC, Chu RW, Cheng CH, Wong S, Tse JM, Lau FL, Yiu MK, Man CW. The destruction of the lower urinary tract by ketamine abuse: a new syndrome? BJU Int. 2008 Dec;102(11):1616-22. doi: 10.1111/j.1464-410X.2008.07920.x. Epub 2008 Aug 1.

Reference Type: BACKGROUND

PMID: 18680495 (View on PubMed)

Shahani R, Streutker C, Dickson B, Stewart RJ. Ketamine-associated ulcerative cystitis: a new clinical entity. Urology. 2007 May;69(5):810-2. doi: 10.1016/j.urology.2007.01.038.

Reference Type: BACKGROUND

PMID: 17482909 (View on PubMed)

Hackett GS, Hemwall G, Montgomery GJS, IL, Charles C. Thomas. Ligament and Tendon Relaxation. 1956.

Reference Type: BACKGROUND

Scarpone M, Rabago DP, Zgierska A, Arbogast G, Snell E. The efficacy of prolotherapy for lateral epicondylosis: a pilot study. Clin J Sport Med. 2008 May;18(3):248-54. doi: 10.1097/JSM.0b013e318170fc87.

Reference Type: BACKGROUND

PMID: 18469566 (View on PubMed)

Seven MM, Ersen O, Akpancar S, Ozkan H, Turkkan S, Yildiz Y, Koca K. Effectiveness of prolotherapy in the treatment of chronic rotator cuff lesions. Orthop Traumatol Surg Res. 2017 May;103(3):427-433. doi: 10.1016/j.otsr.2017.01.003. Epub 2017 Feb 16.

Reference Type: BACKGROUND

PMID: 28215611 (View on PubMed)

Sit RW, Chung VCh, Reeves KD, Rabago D, Chan KK, Chan DC, Wu X, Ho RS, Wong SY. Hypertonic dextrose injections (prolotherapy) in the treatment of symptomatic knee osteoarthritis: A systematic review and meta-analysis. Sci Rep. 2016 May 5;6:25247. doi: 10.1038/srep25247.

Reference Type: BACKGROUND

PMID: 27146849 (View on PubMed)

Hauser RA, Lackner JB, Steilen-Matias D, Harris DK. A Systematic Review of Dextrose Prolotherapy for Chronic Musculoskeletal Pain. Clin Med Insights Arthritis Musculoskelet Disord. 2016 Jul 7;9:139-59. doi: 10.4137/CMAMD.S39160. eCollection 2016.

Reference Type: BACKGROUND

PMID: 27429562 (View on PubMed)

Other Identifiers

DEXTROSE2019

Identifier Type: -

Identifier Source: org_study_id