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What evidence supports the use of Clorpactin (sodium oxychlorosene) for the treatment of urinary tract infections?

Background

Sodium oxychlorosene, more commonly known as oxychlorosene or by its trade name Clorpactin, is a topical antiseptic that slowly releases hypochlorous acid when in solution.1,2 Chemically related products include Dakin’s solution and sodium hypochlorite (ie, bleach).1 Oxychlorosene has traditionally been used as an irrigation for surgical infection prophylaxis, however, this agent has also been used as a topical treatment (usually as an instillation or irrigation) for a variety of other genitourinary, ophthalmic, otolaryngologic, proctologic, and skin and soft tissue infections. The bactericidal effects of oxychlorosene occur via the diffusion of hypochlorous acid through cells walls that causes oxidation and chlorinization of cellular proteins and enzymes, leading to microbial cell lysis and solubilization of the protoplasmic contents of the cell.1,3 The agent has activity against most microorganisms, including gram-positive and gram-negative bacteria, molds, yeasts, viruses, and spores.4

Oxychlorosene has been around for over 50 years but has never officially been approved by the Food and Drug Administration.5 The product is available as powder for reconstitution supplied in 2-gram bottles; directions for preparation summarized in Table 1.1,2

Table 1. Preparation of oxychlorosene.1,2

  1. Pour the contents of 1 bottle into the appropriate amount of cool or lukewarm NS or water for irrigation

    1. To obtain a 0.1% concentration, 2 grams of oxychlorosene should be added to 2L of NS or water

    2. To obtain a 0.2% concentration, 2 grams of oxychlorosene should be added to 1L of NS or water

  2. Stir or shake the solution for 1 to 2 minutes. A residue will appear that is neither pharmacologically active or harmful.

  3. Allow the solution to stand for several minutes. Shake or stir the solution again for an additional 2 to 3 minutes. It is not necessary for the powder to be dissolved completely for activity.

  4. Use the freshly prepared solution for irrigating the infected area.

Note: The prepared solution should preferably be used as soon as possible, but extended stability data for storage at room temperature and refrigeration are available.
Abbreviations: NS=normal saline.

Efficacy in urinary tract infections

Table 2 summarizes 3 small (n ≤ 100 subjects) observational cohort studies evaluating oxychlorosene bladder instillations for the treatment of urinary tract infections (UTIs).4,6,7 All studies were published as conference abstracts, limiting the availability of detailed information pertaining to study methodology and findings. Two of the 3 studies were retrospective, and the third study did not disclose temporality. Studies included patients with multidrug resistant bacteria,4 multiple drug allergies,6 and those who failed oral antibiotic prophylaxis.6 Oxychlorosene regimens varied across studies; solution concentrations ranged from 0.05% to 0.2% and the mean number of treatments ranged from approximately 4 to 14. In the study by Kowalski et al, 67% of patients also continued with prophylactic oral antibiotics during at least a portion of oxychlorosene treatment.

Treatment success ranged from 75% to 92%, but was inconsistently defined across studies.4,6,7 In the study by Kowalski et al, oxychlorosene bladder instillations were generally safe and well tolerated with the most frequently reported adverse effect being discomfort during treatment.6 Stock et al demonstrated fewer adverse events (1 vs 4 patients) with a lower concentration of oxychlorosene without compromising on efficacy.7 Overall, oxychlorosene appears to be an effective treatment for UTIs.

Table 2. Evidence for the use of oxychlorosene bladder instillations for the treatment of urinary tract infections.4,6,7
Citation/
Design		NOxychlorosene regimenTreatment success*
Fleming et al. 2015,4
 
Retrospective chart review (2005 to 2010)		25Solution concentration was not specified; 2 bladder instillations via a urinary catheter every 12 hours
 
Mean number of treatments and duration of therapy (days) was 4.68 and 2.62, respectively		84%
Kowalski et al. 2015.6
 
Chart review (2013 to 2014) 		243 bladder instillations (60 mL) of 0.1% solution held for 60 seconds before draining. Then, normal saline (60 mL) instilled twice.
 
Treatments were repeated weekly for 4 treatments, then spaced to monthly for 4 treatments and then continued every 6 to 8 weeks.
 
Median number of treatments per patient was 14 (range, 2 to 38).		75%
Stock et al. 2013.7
 
Retrospective cohort study		1000.2% or 0.05% solution via bladder irrigation
 
Mean number of treatments and duration of therapy (days) was 5.44 and 2.86, respectively in the 0.2% solution group and 5.04 and 2.68, respectively in the 0.05% solution group		0.2% Solution: 90%
0.05% Solution: 92%
*Treatment success was defined as “cure” by Fleming et al,4 and “overall response” by Stock et al.7 Kowalski et al6 defined clinical improvement as “urine culture obtained during treatment or within 30 days of last treatment with no growth, positive urine culture with less resistant organism or no urine culture obtained due to no clinical symptoms of UTI.”

An additional abstract was published in 2018 evaluating the efficacy of an oxychlorosene foley irrigation protocol to prevent catheter-associated UTIs (CAUTIs) in patients receiving extracorporeal membrane oxygenation (ECMO) support (N=421).8 The protocol was instituted at a single hospital as follows: 2 instillations of 100 mL of 0.2% oxychlorosene in the catheter and bladder starting on day 3 of ECMO and continued every 3 days for the duration of ECMO. During the study period, 224 patients received oxychlorosene instillations and the remainder received protocolized care without oxychlorosene. The rate of CAUTI (incident per thousand patient-ECMO days) was significantly reduced with oxychlorosene (0.83) compared with control (6.18) (p<0.017). Oxychlorosene did not statistically significantly reduce the duration of ICU and overall length of stay; survival off ECMO and to hospital discharge was also not significantly improved with oxychlorosene.

Discussion

Urinary tract infections are the most common type of outpatient and healthcare-associated infection in the United States.9,10 More than half of women will experience at least 1 UTI in their lifetime with increased incidence following menopause.9 The majority of healthcare-associated UTIs are related to placement of a urinary catheter (ie, CAUTIs).10 A 2019 report from the Centers for Disease Control and Prevention discusses the unrelenting threat of antibiotic resistant organisms, and specifically calls out the continued rise in multidrug resistant organisms that cause common infections such as UTIs.11 Oxychlorosene is an older compound with occasional interest for use in UTIs, particularly in the context of antimicrobial resistance. Unlike many traditional antimicrobials used for UTIs, resistance to oxychlorosene is unlikely because of its unique mechanism of action.3

Oxychlorosene is administered as a bladder instillation when used for the treatment of a UTI. While few studies have evaluated oxychlorosene bladder instillations for this purpose, the available evidence points to notable success rates with this therapy, including efficacy in patients with multidrug resistant organisms, failure of oral antimicrobials, and multiple drug allergies.4,6,7 An observational trial also demonstrated a reduction in the rate of CAUTIs following implementation of an oxychlorosene irrigation protocol for patients receiving ECMO support; this study did not demonstrate significant reductions in other endpoints such as survival off ECMO.8

A standardized oxychlorosene regimen for bladder instillation is not available, and schedule and dosing vary across relevant studies using this therapy for UTIs.4,6,7,8 Nonetheless, Clinical Pharmacology database recommends the following oxychlorosene dosing for the treatment of UTIs, including cystitis, interstitial cystitis, and tuberculous cystitis:1

  • Instill 0.1% oxychlorosene solution into the bladder to the maximum tolerated capacity; do not over distend the bladder. A 0.2% oxychlorosene solution can be used for subsequent instillations.
  • Retain each instillation for 2 to 3 minutes. Perform 2 to 3 instillations in a single treatment. Allow several minutes between instillations.
  • Repeat instillations every 4 to 5 days as necessary, for at least 5 treatments, based on patient response. For more resistant organisms, 1 or more treatment(s) per day may be used. Higher concentrations are associated with bladder discomfort and may require anesthetic use. If using higher concentrations, allow 1 month to lapse between the second and third instillations to determine therapeutic response before continuing therapy.

A review article by Otto et al recommends the following volume of oxychlorosene solution for bladder instillation, but does not recommend a specific concentration: 100 to 150 mL via catheter to clear residual urine, then another 100 to 150 mL to dwell in the bladder for about 10 minutes.5 Other resources note that severe bladder discomfort has been associated with use of oxychlorosene bladder instillations with solution concentrations ≥0.2%.1 Therefore, a 0.1% solution is recommended for the first instillation to minimize discomfort. As reported by Stock et al, a 0.05% solution may be just as effective as a 0.1% solution for the treatment of UTIs.7

Oxychlorosene bladder instillation should not be used in patients at risk of vesicoureteral reflux or those patients with abnormal emptying of the bladder including bladder obstruction or urethral stricture.7 Ureteral fibrosis has been reported in patients with vesicoureteral reflux exposed to oxychlorosene. Lastly, undiluted oxychlorosene powder should not be applied directly to the skin due to risk of severe skin irritation, burning, or necrosis.

Summary

While evidence is limited, oxychlorosene bladder instillation does appear to be effective for the management of UTIs. A standardized oxychlorosene regimen is not available for this purpose, but dosing and schedule recommendations are available from reputable resources and fall within the range of what has been reported in relevant studies. Therapy appears to be well tolerated with the exception of bladder discomfort, especially with higher concentrations of oxychlorosene.

References

  1. Clinical Pharmacology. Elsevier, Inc; 2021. Accessed January 20, 2021. https://www-clinicalkey-com.proxy.cc.uic.edu/pharmacology/
  2. Clorpactin WCS-90. Package insert. United-Guardian, Inc. 2018.
  3. Oxychlorosene sodium. Chemical Book, Inc; 2021. Accessed January 20, 2021. https://m.chemicalbook.com/ProductChemicalPropertiesCB52521386_EN.htm
  4. Fleming M and Cheatham SC. Sodium oxychlorosene 0.2% bladder irrigation for treatment of patients with Urinary Tract Infections (UTIs). Abstract presented at: 49th Annual Meeting of the Infectious Diseases Society of America; October 21, 2011; Boston, MA.
  5. Otto AM. Catheter UTIs cleared with old-fashioned oxychlorosene flush. MDedge ObGyn. October 3, 2013. Accessed January 20, 2021. https://www.mdedge.com/obgyn/article/78090/infectious-diseases/catheter-utis-cleared-old-fashioned-oxychlorosene-flush?sso=true
  6. Kowalski J, Takacs E, Erickson BA, Kredler KJ. Intravesical oxychlorosene for recurrent and complicated UTI. Female Pelvic Med Reconstr Surg. September/October 2015;21(5):S55-S146. doi: 10.1097/SPV.0000000000000207
  7. Stock AH, Fleming MR, KaysMB, Cheatham SC. Determination of an optimal oxychlorosene regimen for treatment of urinary tract infections. Abstract presented at: 53rd Annual Meeting of the Interscience Conference on Antimicrobial Agents and Chemotherapy; September 11, 2013; Denver, CO.
  8. Tomlin G, Gutteridge D, Wack M, Layne T, Roe D, Want I. The effect of oxychlorosene foley irrigation on catheter associated urinary tract infections (CAUTIs) in ECMO patients. Abstract presented at: 29th Annual Extracorporeal Life Support Organization Conference; September 13-16, 2018; Scottsdale, AZ.
  9. Medina M, Castillo-Pino E. An introduction to the epidemiology and burden of urinary tract infections. Ther Adv Urol. 2019;11:1756287219832172. doi:10.1177/1756287219832172
  10. Catheter-associated Urinary Tract Infection. Centers for Disease Control and Prevention. October 16, 2015. Accessed January 20, 2021. https://www.cdc.gov/hai/ca_uti/uti.html
  11. Antibiotic resistance threats in the United States, 2019. Centers for Disease Control and Prevention. Published December 2019. Accessed January 20, 2021. https://www.cdc.gov/drugresistance/pdf/threats-report/2019-ar-threats-report-508.pdf

Prepared by:

Katherine Sarna, PharmD, BCPS
Clinical Assistant Professor, Drug Information Specialist
University of Illinois at Chicago College of Pharmacy

February 2021

The information presented is current as January 15, 2021. This information is intended as an educational piece and should not be used as the sole source for clinical decision-making.