Myrbetriq™ (Mirabegron) to Reduce Pain and Discomfort Following Ureteral Stent Placement

NCT02462837 | Terminated Phase 2 Results

• 1 other identifier: MYRB-14B02
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this pilot study is to assess whether Myrbetriq™ will improve post-operative ureteral pain and discomfort, reduce bladder storage symptoms and increase quality of life following ureteral stenting.

Conditions

Urinary Bladder, Overactive; Pain; Lower Urinary Tract Symptoms

Keywords

Ureteral Stents; Pain and Discomfort; Bladder Storage Symptoms

Outcome Measures

Primary Outcomes (6)

• Improvement From Baseline in the Incontinence Symptom Severity Index (ISSI) in the Myrbetriq™ Group at the 2 Week Follow-up Compared to Placebo Group.

  Incontinence symptom severity index is a self-assessment instrument for voiding symptom severity. It assesses 8 symptom domains: emptying, urgency, urge incontinence, nocturia, daytime frequency, stress incontinence, leakage with physical activity, and pad use. absent/mild (0-6), moderate (7-16), severe (\>16).

  2 weeks

• Improvement From Baseline in the Number Micturitions Per 24 Hours in the Myrbetriq™ Group at the 2 Week Follow-up Compared to Placebo Group.

  Only seven patients were enrolled and two of them withdrew after the first dose. Patients did not provide baseline micturitions. They were given a voiding diary after randomization to be conducted prior to their next follow-up visit. Therefore, improvement in the number of micturitions at 2 weeks cannot be analyzed from baseline

  2 weeks

• Improvement From Baseline in the Number of Incontinence Episodes in the Myrbetriq™ Group at the 2 Week Follow-up Compared to Placebo Group.

  Only seven patients were enrolled and two of them withdrew after the first dose. Patients did not provide baseline number of incontinence episodes. They were given a voiding diary after randomization to be conducted pror to their next follow-up visit. Therefore, improvement in the number of incontinence episodes at 2 weeks cannot be analyzed from baseline.

  2 weeks

• Improvement From Baseline in the Incontinence Symptom Severity Index (ISSI) in the Myrbetriq™ Group at the 1 Week Follow-up Compared to Placebo Group.

  Only seven patients were enrolled and two of them withdrew after the first dose. Therefore, we are only left with 5 patients completing the study. Incontinence symptom severity index is a self-assessment instrument for voiding symptom severity. It assesses 8 symptom domains: emptying, urgency, urge incontinence, nocturia, daytime frequency, stress incontinence, leakage with physical activity, and pad use. absent/mild (0-6), moderate (7-16), severe (\>16). .

  1 week

• Improvement From Baseline in the Number Micturitions Per 24 Hours in the Myrbetriq™ Group at the 1 Week Follow-up Compared to Placebo Group.

  Only seven patients were enrolled and two of them withdrew after the first dose. Therefore, we are only left with 5 patients at the one week follow-up. Patients did not provide baseline micturitions. They were given a voiding diary after randomization to be conducted prior to their next follow-up visit. Therefore, improvement in the number of micturitions at 1 week cannot be analyzed from baseline

  1 week

• Improvement From Baseline in the Number of Incontinence Episodes in the Myrbetriq™ Group at the 1 Week Follow-up Compared to Placebo Group.

  Only seven patients were enrolled and two of them withdrew after the first dose. Therefore, we are only left with 5 patients at the one week follow-up. Patients did not provide baseline number of incontinence episodes. They were given a voiding diary after randomization to be conducted pror to their next follow-up visit. Therefore, improvement in the number of incontinence episodes at 1 week cannot be analyzed from baseline.

  1 week

Secondary Outcomes (4)

• Improvement in Pain and Discomfort Perception Using a 10 Point Visual Analog Scale for Pain Assessment (VAS) at the 1 and 2 Week Follow-up.

  1 week, 2 weeks

• Improvement From Baseline on the Patient Global Impression of Severity (PGI-S) at the 2 Week Follow-up.

  2 weeks

• Reduction in Pain Medicine Intake at the 2 Week Follow-up

  2 weeks

• Reduction in Pain Medicine Intake at the 2 Week Follow-up

  2 weeks

Study Arms (2)

Treatment Arm

EXPERIMENTAL

after stent placement, patient will be given Mirabegron 50 mg, PO, once daily, for 2 weeks

Drug: Mirabegron

Placebo Arm

PLACEBO COMPARATOR

after stent placement, patient will be given placebo PO, once daily, for 2 weeks

Drug: Placebo

Interventions

Mirabegron DRUG

Also known as: Myrbetriq

Treatment Arm

Placebo DRUG

Placebo Arm

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18.
• Subject scheduled to undergo a ureteral stent placement for ureteral obstruction or post- ureteroscopy procedure.
• Otherwise healthy subjects who are able and willing to participate in the study.
• None of the planned interventions are documented in the labeled contraindications, warnings and precautions of the study drug.

You may not qualify if:

• Does NOT give consent.
• Subject is using prohibited medications which cannot be stopped safely at the screening visit. Subject is excluded if using restricted medications not meeting protocol-specified criteria:
• (i) Phytotherapy for BPH or a 5-alpha reductase inhibitor within 3 months, with persistent urinary symptoms and AUASS more than 7.
• (ii) Taken an oral alpha agonist, anticholinergic or cholinergic medication within 5 days of the first screening visit with the following exception(s): a singular dose given in ER or on the hospital floor prior to procedure, topical anticholinergic eye drops used for glaucoma or inhaled anti-cholinergic used for COPD.
• (iii) Taken tricyclic antidepressants within 2 weeks of the first screening visit.
• (iv) Taken an estrogen, androgen, or any drug producing androgen suppression, or anabolic steroids within 3 months with the following exceptions: any topical creams for local treatment.
• Post void residual volume \> 350 mL.
• Female subject is breastfeeding, pregnant, intends to become pregnant during the study, or of childbearing potential is sexually active and not practicing a highly reliable method of birth control.
• Subject has known neurogenic bladder.
• Subject with uncontrolled chronic pain problems or on chronic pain medications.
• Subject has significant stress incontinence or mixed stress/urgency incontinence where stress is the predominant factor as determined by the investigator (for female subjects confirmed by a cough provocation test).
• Subject has an indwelling catheter or practices intermittent self-catheterization.
• Known primary neurologic conditions such as multiple sclerosis, Parkinson's disease, diabetic neuropathy or any neurological diseases known to affect bladder function.
• Subject has evidence of a symptomatic active urinary tract infection, chronic inflammation such as interstitial cystitis, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs, or bladder stones (which can be located in different anatomical location and can cause LUTS similar to bladder infection and pain related to their location in the bladder which could mask the treatment effect).
• Subject who is currently under active treatment with botulinum toxin (and all other bladder paralytics) intravesically.

Sponsors & Collaborators

• Southern Illinois University: lead
• Astellas Scientific & Medical Affairs, Inc.: collaborator
• Sisters of the Third Order of St. Francis: collaborator

Study Sites (1)

SIUSOM - Division of Urology

Springfield, Illinois, 62794-9665, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive; Pain; Lower Urinary Tract Symptoms

Interventions

mirabegron

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations

Results Point of Contact

• Title: Dr. Danuta Dynda
• Organization: Southern Illinois University School of Medicine

ddynda@siumed.edu

217-545-7443

Study Officials

• Ahmed El-Zawahry, MD

  SIUSOM - Division of Urology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2015
• First Posted: June 4, 2015
• Study Start: May 1, 2015
• Primary Completion: January 30, 2019
• Study Completion: January 30, 2019
• Last Updated: June 13, 2023
• Results First Posted: June 13, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)