Ureteral Stent-related Pain and Mirabegron (SPAM) Trial

NCT02095665 | Completed Phase 4

• 1 other identifier: SPAM
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Ureteric stents are used often following ureteroscopy for prevention of obstruction from edema and or stone fragments. They are often associated with pain, voiding often, the need to urinate quickly and finding blood in the urine called "lower urinary tract symptoms" or LUTS for short. There is randomized studies showing the efficacy of α-blockers such as tamsulosin in relieving "stent symptoms" (pain and LUTS). There is emerging but limited evidence to show that antimuscarinic medications, used to treat overactive bladder (OAB) have some efficacy in decreasing stent symptoms. Mirabegron is a beta-agonist used to decrease OAB symptoms. Mirabegron functions to mediate relaxation of the detrusor muscle and has been useful in treating OAB symptoms. Conventional antimuscarinic medications often have bothersome side effects like dry mouth, constipation, blurred vision and cognitive impairment. This may limit their use in some populations. Mirabegron is well-tolerated with a good safety profile and therefore may be useful in treating stent symptoms without the bothersome side effects commonly seen with antimuscarinic medications. . The investigators hypothesize that mirabegron is effective in decreasing ureteral stent related LUTS and pain.

Conditions

Nephrolithiasis

Keywords

ureteric stents; LUTS; lower urinary tract symptoms

Outcome Measures

Primary Outcomes (1)

• Ureteral stent related pain and lower urinary tract symptoms (LUTS) as measured by the Ureteral Stent Symptom Questionnaire.

  The primary objective of this study is to determine if mirabegron is effective in decreasing ureteral stent related lower urinary tract symptoms (LUTS) following ureteroscopy for urolithiasis when compared to tamsulosin alone and in combination. Utilizing the Ureteral Stent Symptom Questionnaire, a self-administered questionnaire participants will report their urinary symptoms for comparison, enabling the comparison through out the different treatment arms.

  Measured twice, once at the time of surgery when stent is inserted and secondly at the time the stent is removed which will occur 5 to 10 days following surgery.

Secondary Outcomes (1)

• Quality of life impact of mirabegron for stent symptoms as measured with the Ureteral Stent Symptoms Questionnaire.

  Measured twice, once at the time of surgery when stent is inserted and secondly at the time the stent is removed occuring 5 to 10 days later.

Study Arms (4)

Narcotic analegesic only

ACTIVE COMPARATOR

Drug: Tylenol #3 1 tablet every six hours as necessary

Drug: Tylenol #3

Mirabegron and narcotic analgesia

ACTIVE COMPARATOR

Drug : Mirabegron 50 mg oral daily Drug: Tylenol #3 1 tablet every six hours as necessary

Drug: Mirabegron; Drug: Tylenol #3

Tamsulosin and narcotic analgesia

ACTIVE COMPARATOR

Drug: Tamsulosin 0.4mg oral daily Drug: Tylenol #3 1 tablet every six hours as necessary

Drug: Tamsulosin; Drug: Tylenol #3

Mirabegron, Tamsulosin and narcotic

EXPERIMENTAL

Drug: Mirabegron 50 mg oral daily Drug: Tamsulosin 0.4mg oral daily Drug: Tylenol #3 1 tablet every six hours as necessary

Drug: Mirabegron; Drug: Tamsulosin; Drug: Tylenol #3

Interventions

Mirabegron DRUG

50 mg of Mirabegron daily from stent insertion until removal 5 to 10 days

Also known as: Myrbertiq

Mirabegron and narcotic analgesia; Mirabegron, Tamsulosin and narcotic

Tamsulosin DRUG

0.4 mg of Tamsulosin daily and 1 tab of Percocet every 4 hours as necessary from stent insertion until removal 5 to 10 days

Also known as: Flomax

Mirabegron, Tamsulosin and narcotic; Tamsulosin and narcotic analgesia

Tylenol #3 DRUG

1 tab of Tylenol #3 every 6 hours as necessary from stent insertion until removal 5 to 10 days

Also known as: Atasol

Mirabegron and narcotic analgesia; Mirabegron, Tamsulosin and narcotic; Narcotic analegesic only; Tamsulosin and narcotic analgesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• First presentation for ureteroscopy for this particular stone
• Planned insertion of double J ureteral stent
• Planned ureteral stenting ≥5 days
• Follow-up conducted at the Queen Elizabeth II Health Sciences Centre

You may not qualify if:

• Bilateral ureteral stents to be inserted
• Stent already in situ prior to ureteroscopy
• Patients with congenital renal abnormalities (ie: horseshoe kidney, ectopic kidney, etc)
• Patients with urinary diversion
• Patients with a history of interstitial cystitis/painful bladder syndrome, chronic prostatitis, or neurogenic bladder
• Indwelling foley catheter
• Active urinary tract infection
• Patients currently taking antimuscarinics, mirabegron, or α-blockers
• Patients with contraindications to receiving either mirabegron or tamsulosin (ie: urinary retention, end-stage renal disease, orthostatic hypotension, uncontrolled hypertension, known QT prolongation, severe aortic regurgitation), significant cognitive impairment, pregnancy, and active urinary tract infection
• Planned upcoming elective cataract surgery
• Suspected or confirmed ureteral perforation

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Study Sites (1)

Nova Scotia Health Authority, Central

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

MeSH Terms

Conditions

Nephrolithiasis; Lower Urinary Tract Symptoms

Interventions

mirabegron; Tamsulosin; Acetaminophen

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Acetanilides; Anilides; Aniline Compounds; Amines

Study Officials

• Andrea G Lantz, MD

  Staff Urologist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2014
• First Posted: March 26, 2014
• Study Start: January 1, 2014
• Primary Completion: March 23, 2018
• Study Completion: March 23, 2018
• Last Updated: November 8, 2022

Record last verified: 2022-11

Locations

CA (1)