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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04807920
Other study ID # 3-2021
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date September 23, 2021
Est. completion date June 2023

Study information

Verified date March 2021
Source Walter Reed National Military Medical Center
Contact Joy E Wheat, MD
Phone 201-710-5109
Email joy.e.wheat.mil@mail.mil
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the study will be to assess the efficacy and safety of bladder BOTOX® for overactive bladder symptoms, such as urinary urgency and frequency, given at the time of prolapse surgery.


Description:

After being informed about the study and the potential risks, women scheduled for prolapse surgery will be screened for bothersome overactive bladder symptoms. Those that qualify and choose to enroll will be randomized to receive either bladder BOTOX® or a placebo at the time of their surgery. Neither the patient nor the investigators will know if the patient receives BOTOX® or a placebo. Subjects will complete questionnaires and bladder diaries both before and after surgery to determine efficacy and patient satisfaction. Potential adverse events, such as urinary tract infections and urinary retention, will be monitored throughout the study.


Recruitment information / eligibility

Status Recruiting
Enrollment 138
Est. completion date June 2023
Est. primary completion date June 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Women scheduled for prolapse surgery - Bothersome OAB symptoms determined by a score of >20 on the OAB-q SF - Willingness to perform clean intermittent catheterization (CIC) - Ability to follow study instructions and complete required follow up Exclusion Criteria: - Contraindications or allergy to Onabotulinumtoxin A - Intravesical Onabotulinumtoxin A within 3 months of the planned surgery date - Total body Onabotulinumtoxin A dose of = 400 Units in the 3 months prior to the scheduled surgery date. - Inability or unwillingness to self-catheterize - Post-void residual = 200mL - Neurogenic bladder or other neurological diseases that may cause voiding dysfunction - Concurrent use of other pharmacological treatment for the treatment of OAB symptoms at the time of prolapse repair surgery. - Females who are pregnant, think they may be pregnant at the start of the study, planning a pregnancy during the active treatment phase of the study, or who are unwilling or unable to use a reliable form of contraception during the active treatment phase of the study. - Inability to speak or read English

Study Design


Intervention

Drug:
OnabotulinumtoxinA 100 UNT
Intravesical injection
Other:
Injectable saline
Intravesical injection

Locations

Country Name City State
United States Walter Reed National Military Medical Center Bethesda Maryland

Sponsors (1)

Lead Sponsor Collaborator
Walter Reed National Military Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (30)

Abrams P, Andersson KE, Birder L, Brubaker L, Cardozo L, Chapple C, Cottenden A, Davila W, de Ridder D, Dmochowski R, Drake M, Dubeau C, Fry C, Hanno P, Smith JH, Herschorn S, Hosker G, Kelleher C, Koelbl H, Khoury S, Madoff R, Milsom I, Moore K, Newman D — View Citation

Brubaker L, Richter HE, Visco A, Mahajan S, Nygaard I, Braun TM, Barber MD, Menefee S, Schaffer J, Weber AM, Wei J; Pelvic Floor Disorders Network. Refractory idiopathic urge urinary incontinence and botulinum A injection. J Urol. 2008 Jul;180(1):217-22. — View Citation

Chapple C, Sievert KD, MacDiarmid S, Khullar V, Radziszewski P, Nardo C, Thompson C, Zhou J, Haag-Molkenteller C. OnabotulinumtoxinA 100 U significantly improves all idiopathic overactive bladder symptoms and quality of life in patients with overactive bl — View Citation

Clinical Consensus Statement: Association of Anticholinergic Medication Use and Cognition in Women With Overactive Bladder. Female Pelvic Med Reconstr Surg. 2021 Feb 1;27(2):69-71. doi: 10.1097/SPV.0000000000001008. — View Citation

Coyne KS, Sexton CC, Vats V, Thompson C, Kopp ZS, Milsom I. National community prevalence of overactive bladder in the United States stratified by sex and age. Urology. 2011 May;77(5):1081-7. doi: 10.1016/j.urology.2010.08.039. Epub 2011 Jan 22. — View Citation

de Boer TA, Kluivers KB, Withagen MI, Milani AL, Vierhout ME. Predictive factors for overactive bladder symptoms after pelvic organ prolapse surgery. Int Urogynecol J. 2010 Sep;21(9):1143-9. doi: 10.1007/s00192-010-1152-y. Epub 2010 Apr 24. — View Citation

de Boer TA, Salvatore S, Cardozo L, Chapple C, Kelleher C, van Kerrebroeck P, Kirby MG, Koelbl H, Espuna-Pons M, Milsom I, Tubaro A, Wagg A, Vierhout ME. Pelvic organ prolapse and overactive bladder. Neurourol Urodyn. 2010;29(1):30-9. doi: 10.1002/nau.208 — View Citation

Dmochowski R, Chapple C, Nitti VW, Chancellor M, Everaert K, Thompson C, Daniell G, Zhou J, Haag-Molkenteller C. Efficacy and safety of onabotulinumtoxinA for idiopathic overactive bladder: a double-blind, placebo controlled, randomized, dose ranging tria — View Citation

Dmochowski RR, Thai S, Iglay K, Enemchukwu E, Tee S, Varano S, Girman C, Radican L, Mudd PN Jr, Poole C. Increased risk of incident dementia following use of anticholinergic agents: A systematic literature review and meta-analysis. Neurourol Urodyn. 2021 — View Citation

Drake MJ, Nitti VW, Ginsberg DA, Brucker BM, Hepp Z, McCool R, Glanville JM, Fleetwood K, James D, Chapple CR. Comparative assessment of the efficacy of onabotulinumtoxinA and oral therapies (anticholinergics and mirabegron) for overactive bladder: a syst — View Citation

Eapen RS, Radomski SB. Review of the epidemiology of overactive bladder. Res Rep Urol. 2016 Jun 6;8:71-6. doi: 10.2147/RRU.S102441. eCollection 2016. Review. — View Citation

Foster RT Sr, Barber MD, Parasio MF, Walters MD, Weidner AC, Amundsen CL. A prospective assessment of overactive bladder symptoms in a cohort of elderly women who underwent transvaginal surgery for advanced pelvic organ prolapse. Am J Obstet Gynecol. 2007 — View Citation

Fowler CJ, Auerbach S, Ginsberg D, Hale D, Radziszewski P, Rechberger T, Patel VD, Zhou J, Thompson C, Kowalski JW. OnabotulinumtoxinA improves health-related quality of life in patients with urinary incontinence due to idiopathic overactive bladder: a 36 — View Citation

Ganz ML, Smalarz AM, Krupski TL, Anger JT, Hu JC, Wittrup-Jensen KU, Pashos CL. Economic costs of overactive bladder in the United States. Urology. 2010 Mar;75(3):526-32, 532.e1-18. doi: 10.1016/j.urology.2009.06.096. Epub 2009 Dec 29. — View Citation

Granese R, Adile G, Gugliotta G, Cucinella G, Saitta S, Adile B. Botox(®) for idiopathic overactive bladder: efficacy, duration and safety. Effectiveness of subsequent injection. Arch Gynecol Obstet. 2012 Oct;286(4):923-9. doi: 10.1007/s00404-012-2349-8. — View Citation

Herschorn S, Kohan A, Aliotta P, McCammon K, Sriram R, Abrams S, Lam W, Everaert K. The Efficacy and Safety of OnabotulinumtoxinA or Solifenacin Compared with Placebo in Solifenacin Naïve Patients with Refractory Overactive Bladder: Results from a Multice — View Citation

Irwin DE, Milsom I, Hunskaar S, Reilly K, Kopp Z, Herschorn S, Coyne K, Kelleher C, Hampel C, Artibani W, Abrams P. Population-based survey of urinary incontinence, overactive bladder, and other lower urinary tract symptoms in five countries: results of t — View Citation

Johnson JR, High RA, Dziadek O, Ocon A, Muir TW, Xu J, Antosh DD. Overactive Bladder Symptoms After Pelvic Organ Prolapse Repair. Female Pelvic Med Reconstr Surg. 2020 Dec 1;26(12):742-745. doi: 10.1097/SPV.0000000000000700. — View Citation

Komar A, Bretschneider CE, Mueller MG, Lewicky-Gaupp C, Collins S, Geynisman-Tan J, Tavathia M, Kenton K. Concurrent Retropubic Midurethral Sling and OnabotulinumtoxinA for Mixed Urinary Incontinence: A Randomized Controlled Trial. Obstet Gynecol. 2021 Ja — View Citation

Lightner DJ, Gomelsky A, Souter L, Vasavada SP. Diagnosis and Treatment of Overactive Bladder (Non-Neurogenic) in Adults: AUA/SUFU Guideline Amendment 2019. J Urol. 2019 Sep;202(3):558-563. doi: 10.1097/JU.0000000000000309. Epub 2019 Aug 8. — View Citation

Melville JL, Katon W, Delaney K, Newton K. Urinary incontinence in US women: a population-based study. Arch Intern Med. 2005 Mar 14;165(5):537-42. — View Citation

Minassian VA, Bazi T, Stewart WF. Clinical epidemiological insights into urinary incontinence. Int Urogynecol J. 2017 May;28(5):687-696. doi: 10.1007/s00192-017-3314-7. Epub 2017 Mar 20. Review. — View Citation

Miotla P, Futyma K, Cartwright R, Bogusiewicz M, Skorupska K, Markut-Miotla E, Rechberger T. Effectiveness of botulinum toxin injection in the treatment of de novo OAB symptoms following midurethral sling surgery. Int Urogynecol J. 2016 Mar;27(3):393-8. d — View Citation

Sexton CC, Coyne KS, Thompson C, Bavendam T, Chen CI, Markland A. Prevalence and effect on health-related quality of life of overactive bladder in older americans: results from the epidemiology of lower urinary tract symptoms study. J Am Geriatr Soc. 2011 — View Citation

Sexton CC, Notte SM, Maroulis C, Dmochowski RR, Cardozo L, Subramanian D, Coyne KS. Persistence and adherence in the treatment of overactive bladder syndrome with anticholinergic therapy: a systematic review of the literature. Int J Clin Pract. 2011 May;6 — View Citation

Shepherd JP, Carter-Brooks CM, Chermanksy C. A cost-effectiveness analysis of Onabotulinumtoxin A as first-line treatment for overactive bladder. Int Urogynecol J. 2018 Aug;29(8):1213-1219. doi: 10.1007/s00192-018-3653-z. Epub 2018 Apr 18. — View Citation

Stewart WF, Van Rooyen JB, Cundiff GW, Abrams P, Herzog AR, Corey R, Hunt TL, Wein AJ. Prevalence and burden of overactive bladder in the United States. World J Urol. 2003 May;20(6):327-36. Epub 2002 Nov 15. — View Citation

Sung VW, Borello-France D, Newman DK, Richter HE, Lukacz ES, Moalli P, Weidner AC, Smith AL, Dunivan G, Ridgeway B, Nguyen JN, Mazloomdoost D, Carper B, Gantz MG; NICHD Pelvic Floor Disorders Network. Effect of Behavioral and Pelvic Floor Muscle Therapy C — View Citation

Sussman D, Yehoshua A, Kowalski J, Lee W, Kish J, Chaudhari S, Murray B. Adherence and persistence of mirabegron and anticholinergic therapies in patients with overactive bladder: a real-world claims data analysis. Int J Clin Pract. 2017 Mar;71(3-4). doi: — View Citation

Visco AG, Brubaker L, Richter HE, Nygaard I, Paraiso MF, Menefee SA, Schaffer J, Lowder J, Khandwala S, Sirls L, Spino C, Nolen TL, Wallace D, Meikle SF; Pelvic Floor Disorders Network. Anticholinergic therapy vs. onabotulinumtoxina for urgency urinary in — View Citation

* Note: There are 30 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline to postoperative weeks 6 to 12 in Overactive Bladder bother short form (OAB-q SF) questionnaire looking for a decrease of 10 points, which is the minimally important difference. The OAB-q SF is a validated 6 item questionnaire that is scored and reported on a 0 to 100 point scale with increasing scores indicating more bother. From baseline (time of enrollment) to 6-12 weeks postoperatively
Secondary Change from baseline to postoperative weeks 6 to 12 in the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire short form (PISQ-12). The PISQ-12 is a 12 item validated questionnaire that evaluates sexual function in women with urinary incontinence and/or pelvic organ prolapse. It is reported on a scale of 0-48, with a higher score indicating worse sexual function. From baseline (time of enrollment) to 6-12 weeks postoperatively
Secondary Change from baseline to postoperative weeks 6 to 12 in Patient Global Impression of Severity Scale (PGI-S). The PGI-S is a 7 point Likert scale, ranging from 1 to 7, with an increasing score indicating greater severity. From baseline (time of enrollment) to 6-12 weeks postoperatively
Secondary Patient Global Impression of Improvement Scale (PGI-I) at 6 to 12 weeks postoperatively. The PGI-I is a 7 point Likert scale, ranging from 1 to 7, with an increasing score indicating less improvement. At 6-12 weeks postoperatively
Secondary Urinary tract infection Rate of urinary tract infections based on clinical suspicion and urine culture results From time of treatment to 12 weeks postoperative
Secondary Urinary retention Rate of urinary retention requiring catheterization, defined as a post-void residual of more than 400mL or 200-400mL with symptoms of incomplete bladder emptying. From 2 weeks postoperatively to 12 weeks postoperatively
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