Randomization of Botox for Stent Pain and Irritative Voiding Symptoms

NCT02078895 | Terminated Phase 3

• 1 other identifier: 2013-9702
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Botulinum toxin type A (Botox A) has shown great success in treating certain urologic conditions. A recent study has documented that Botox injected around the ureteral orifice (or place where the tube that connects the kidney to the bladder enters the bladder), during placement of a ureteral stent (small rubber tube that facilitate drainage of urine from the kidney to the bladder), resulted in a marked decline in the amount of stent pain experienced by patients. This finding was quite remarkable as stents are commonly used in many Urologic conditions, and these stents produce a remarkable degree of patient discomfort. Despite the great improvement in pain reduction, the irritative voiding symptoms \[frequent need to void, urgency, burning with urination (dysuria) or nighttime voiding (nocturia)\] were not ameliorated by the Botox injections in the ureteral orifice. However, it has already been well documented that in other clinical settings, administrations of Botox into the bladder muscle, has been shown to reduce these irritative symptoms. The objective of the study is to determine if pain and irritative lower urinary tract symptoms related to ureteral stent placement will improve after the injection of Botox around the ureteral orifice and in the bladder itself.

Conditions

Lower Urinary Tract Discomfort; Stent Pain

Keywords

Lower Urinary tract discomfort , ureteral stent pain

Outcome Measures

Primary Outcomes (1)

• Change in Lower Urinary Tract Discomfort between pre-operative visit date and the stent removal date and two week follow up.

  Lower urinary tract symptoms (frequency, urgency, nocturia, dysuria) - Ureteral Stent Symptom Questionnaire (USSQ). The USSQ has different sections that pertain to different domains of a patient's life. Therefore, a total score from each section will be measured individually as described by Joshi et al (15). The different domains of the USSQ include urinary symptoms, body pain, general health, work performance, sexual matters. The total scores from each of these sections will be compared individually. In addition, the total score for the entire questionnaire will also be assessed.

  At pre-operative visit (average of 7 days before stent placement), stent removal date (3-9 days after stent placement), and 2 week follow up (2 weeks after stent placement)

Secondary Outcomes (2)

• Post-operative pain

  At pre-operative visit (average of 7 days before stent placement), stent removal date (3-9 days after stent placement), and 2 week follow up (2 weeks after stent placement)

• Post-surgical analgesic requirements

  post-operative to follow up day (2 weeks)

Study Arms (2)

Botox

EXPERIMENTAL

The experimental group will include ureteral stent placement with three peri-ureteral injections of Botox A and fourteen site-specific intradetrusor injections of Botox A.

Drug: Botox

Control

NO INTERVENTION

The control group will involve a ureteral stent placement with no injection.

Interventions

Botox DRUG

Peri-Ureteral and Intradetrusor Injection of Botulinum Toxin Type A

Also known as: Botulinum Toxin Type A

Botox

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients requiring unilateral ureteral stent insertion
• Age \> 18
• Renal/ureteral stones (single or multiple)
• Ureteral strictures
• Surveillance ureterscopy
• Willing and able to consent
• Willing and able to complete study questionnaires/diaries
• Willing to use CIC to empty the bladder at any time after study treatment if it is determined to be necessary by the investigator

You may not qualify if:

• History of malignancy
• Patients on medical therapy for benign prostatic hyperplasia (alpha blocker and/or 5alpha reductase inhibitor)
• Patients taking muscarinic-receptor antagonists (Ex. detrol, ditropan etc.)
• Patients who have an interstim sacral neuromodulator
• History of urinary retention
• Neurogenic or non-neurogenic detrusor overactivity
• Pregnancy
• Solitary kidney
• Insulin dependent Diabetes Mellitus (Uncontrolled Diabetes (HbA1c \> 8))
• Neuropathy
• History of transplant kidney
• History of narcotic abuse or chronic pain
• Anatomic bladder/ureteral abnormality
• Previous cystectomy/urinary diversion
• Conditions necessitating bilateral ureteral stents

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

University of California, Irvine Medical Center

Orange, California, 92868, United States

Location

Related Publications (15)

• Gupta M, Patel T, Xavier K, Maruffo F, Lehman D, Walsh R, Landman J. Prospective randomized evaluation of periureteral botulinum toxin type A injection for ureteral stent pain reduction. J Urol. 2010 Feb;183(2):598-602. doi: 10.1016/j.juro.2009.10.021. Epub 2009 Dec 16.

  PMID: 20018320 BACKGROUND

• Brin MF. Botulinum toxin: chemistry, pharmacology, toxicity, and immunology. Muscle Nerve Suppl. 1997;6:S146-68.

  PMID: 9826987 BACKGROUND

• Herschorn S, Gajewski J, Ethans K, Corcos J, Carlson K, Bailly G, Bard R, Valiquette L, Baverstock R, Carr L, Radomski S. Efficacy of botulinum toxin A injection for neurogenic detrusor overactivity and urinary incontinence: a randomized, double-blind trial. J Urol. 2011 Jun;185(6):2229-35. doi: 10.1016/j.juro.2011.02.004. Epub 2011 Apr 16.

  PMID: 21497851 BACKGROUND

• Kalsi V, Apostolidis A, Gonzales G, Elneil S, Dasgupta P, Fowler CJ. Early effect on the overactive bladder symptoms following botulinum neurotoxin type A injections for detrusor overactivity. Eur Urol. 2008 Jul;54(1):181-7. doi: 10.1016/j.eururo.2007.12.029. Epub 2007 Dec 26.

  PMID: 18191323 BACKGROUND

• Schmid DM, Sauermann P, Werner M, Schuessler B, Blick N, Muentener M, Strebel RT, Perucchini D, Scheiner D, Schaer G, John H, Reitz A, Hauri D, Schurch B. Experience with 100 cases treated with botulinum-A toxin injections in the detrusor muscle for idiopathic overactive bladder syndrome refractory to anticholinergics. J Urol. 2006 Jul;176(1):177-85. doi: 10.1016/S0022-5347(06)00590-8.

  PMID: 16753396 BACKGROUND

• Rapp DE, Lucioni A, Katz EE, O'Connor RC, Gerber GS, Bales GT. Use of botulinum-A toxin for the treatment of refractory overactive bladder symptoms: an initial experience. Urology. 2004 Jun;63(6):1071-5. doi: 10.1016/j.urology.2004.01.041.

  PMID: 15183952 BACKGROUND

• Dykstra D, Enriquez A, Valley M. Treatment of overactive bladder with botulinum toxin type B: a pilot study. Int Urogynecol J Pelvic Floor Dysfunct. 2003 Dec;14(6):424-6. doi: 10.1007/s00192-003-1099-3. Epub 2003 Nov 25.

  PMID: 14677005 BACKGROUND

• Ghei M, Maraj BH, Miller R, Nathan S, O'Sullivan C, Fowler CJ, Shah PJ, Malone-Lee J. Effects of botulinum toxin B on refractory detrusor overactivity: a randomized, double-blind, placebo controlled, crossover trial. J Urol. 2005 Nov;174(5):1873-7; discussion 1877. doi: 10.1097/01.ju.0000177477.83991.88.

  PMID: 16217327 BACKGROUND

• Schurch B, Stohrer M, Kramer G, Schmid DM, Gaul G, Hauri D. Botulinum-A toxin for treating detrusor hyperreflexia in spinal cord injured patients: a new alternative to anticholinergic drugs? Preliminary results. J Urol. 2000 Sep;164(3 Pt 1):692-7. doi: 10.1097/00005392-200009010-00018.

  PMID: 10953127 BACKGROUND

• Reitz A, Stohrer M, Kramer G, Del Popolo G, Chartier-Kastler E, Pannek J, Burgdorfer H, Gocking K, Madersbacher H, Schumacher S, Richter R, von Tobel J, Schurch B. European experience of 200 cases treated with botulinum-A toxin injections into the detrusor muscle for urinary incontinence due to neurogenic detrusor overactivity. Eur Urol. 2004 Apr;45(4):510-5. doi: 10.1016/j.eururo.2003.12.004.

  PMID: 15041117 BACKGROUND

• Staskin DR, Dmochowski RR, Sand PK, Macdiarmid SA, Caramelli KE, Thomas H, Hoel G. Efficacy and safety of oxybutynin chloride topical gel for overactive bladder: a randomized, double-blind, placebo controlled, multicenter study. J Urol. 2009 Apr;181(4):1764-72. doi: 10.1016/j.juro.2008.11.125. Epub 2009 Feb 23.

  PMID: 19233423 BACKGROUND

• Duvdevani M, Chew BH, Denstedt JD. Minimizing symptoms in patients with ureteric stents. Curr Opin Urol. 2006 Mar;16(2):77-82. doi: 10.1097/01.mou.0000193375.29942.0f.

  PMID: 16479208 BACKGROUND

• Beiko DT, Knudsen BE, Denstedt JD. Advances in ureteral stent design. J Endourol. 2003 May;17(4):195-9. doi: 10.1089/089277903765444294.

  PMID: 12816579 BACKGROUND

• Chew BH, Duvdevani M, Denstedt JD. New developments in ureteral stent design, materials and coatings. Expert Rev Med Devices. 2006 May;3(3):395-403. doi: 10.1586/17434440.3.3.395.

  PMID: 16681460 BACKGROUND

• Joshi HB, Newns N, Stainthorpe A, MacDonagh RP, Keeley FX Jr, Timoney AG. Ureteral stent symptom questionnaire: development and validation of a multidimensional quality of life measure. J Urol. 2003 Mar;169(3):1060-4. doi: 10.1097/01.ju.0000049198.53424.1d.

  PMID: 12576846 BACKGROUND

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Jaime Landman, MD

  University of California, Irvine Department of Urology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Urology Chair

Study Record Dates

• First Submitted: February 26, 2014
• First Posted: March 5, 2014
• Study Start: February 1, 2014
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: August 23, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)