Over Active Bladder Instillation Study - Botox

NCT00667095 | Terminated Phase 3 Results DMC

• 1 other identifier: 07-007399
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether women with overactive bladder (OAB) who receive direct instillation via a catheter of a Botulinum-A Toxin (Botox) with Dimethyl Sulfoxide (DMSO) solution experience significantly better improvement of their OAB symptoms when compared to a similar group of women with OAB who receive instillation of DMSO only.

Conditions

Overactive Bladder; Urinary Urge Incontinence; Urinary Incontinence; Detrusor Hyperreflexia; Urge Incontinence

Keywords

OAB; Over Active Bladder; overactive bladder; Urinary Urge Incontinence; Urinary Incontinence; Botox; DMSO; bladder instillation; instillation; detrusor hyperreflexia; urge incontinence

Outcome Measures

Primary Outcomes (1)

• Change in Incontinence Quality of Life (I-QoL) Score

  The I-QoL measures the effect of urinary incontinence on quality of life. It is divided into 3 subscales: 1) avoidance and limiting behavior, 2) psychosocial impact, and 3) social embarrassment. The I-QOL is comprised of 22 items, each with the response scale from '1= Extremely' to '5= Not at all'. A mean score for each subscale is calculated (averaging the scores for the items in each subscale) as well as a total score for all 22 items (sum of all subscale scores). The scores are then transformed to a 'Scale score' ranging from 0-100 points for ease of interpretation: Scale score = (sum of the items - lowest possible score)/possible raw score range X 100. Higher scores indicate less impact of incontinence on quality of life.

  Baseline, 1 month, 3 months

Secondary Outcomes (5)

• Change in Incontinence Impact Questionnaire Short Form (IIQ-7)

  baseline, 1 month, 3 months

• Change in International Consultation on Incontinence Questionnaire - Short Form Score (ICIQ-SF)

  baseline, 1 month, 3 months

• Change in Urogenital Distress Inventory (UDI-6)

  baseline, 1 month, 3 months

• Number of Participants With Decrease in Blaivas-Groutz Anti-Incontinence Score at 1 Month and 3 Months

  baseline, 1 month, 3 months

• Number of Participants With a Decrease in Urinary Urgency at 1 Month and 3 Months

  Baseline, 1 month, 3 months

Study Arms (2)

Botox and DMSO instillation

EXPERIMENTAL

Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution

Drug: Botox Instillation; Drug: DMSO Instillation

DMSO instillation

PLACEBO COMPARATOR

Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters

Drug: DMSO Instillation

Interventions

Botox Instillation DRUG

Botox instilled into the bladder via ureteral catheter and retained for up to 30 minutes then spontaneously voided.

Also known as: Botulinum-A Toxin, Botox

Botox and DMSO instillation

DMSO Instillation DRUG

DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided.

Also known as: Dimethyl Sulfoxide, DMSO

Botox and DMSO instillation; DMSO instillation

Eligibility Criteria

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

You may qualify if:

• Female patient aged 18 years or older
• No evidence of stress urinary incontinence on physical examination or urodynamics
• Patients who have failed prior drug therapy for overactive bladder or detrusor hyperreflexia
• Patients with symptoms and signs of OAB, detrusor hyperreflexia, urinary urgency, urinary urge incontinence.
• Patient who is mentally competent with the ability to understand and comply with the requirements of the study
• Patient who agrees to be available for the follow-up evaluations as required by the protocol
• Patient who has given signed informed consent

You may not qualify if:

• Patient with Post-Void Residual Urine (PVRU) greater than 100 ml on repeated measures. (Patient with a single PVRU of \>100 ml and followed by two consecutive PVRU measurements of \<100 ml may be included in the study)
• Patient with greater than vesicoureteral reflux grade 1, interstitial cystitis, genitourinary fistulae
• Patient with pelvic organ prolapse stage III or IV, i.e. the most distal part of the prolapse protruding more than 1 cm beyond the hymen (\>+1), at straining
• Patient with un-investigated hematuria
• Patient with lower tract genitourinary malignancies
• Patient on current medication for stress urinary incontinence, such as alpha-adrenergic agonists or duloxetine, within three weeks prior to completing the baseline Bladder Diary (estrogen therapy on a stable dose for at least two months prior to study start is allowed)
• Patient with ongoing complications of prior anti-incontinence surgery
• Patient who is pregnant, lactating, or planning to become pregnant within the study period
• Patient who has received pelvic radiation
• Patient with any condition, which could lead to significant postoperative complications, including current infection and uncontrolled diabetes.
• Patient who is morbidly obese (defined as BMI \> 40 Kg/m2)
• Patient who is bedridden, institutionalized or in such physical condition that she cannot move to the closest bathroom without assistance from another person
• Patient with any condition that would preclude treatment due to contraindications and/or warnings in the study product's labeling
• Patient on immunomodulatory therapy (suppressive or stimulatory)
• Patient with known lidocaine hypersensitivity or hypersensitivity to any anesthetics to be used during the treatment session/surgical procedure

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Related Publications (1)

• Petrou SP, Parker AS, Crook JE, Rogers A, Metz-Kudashick D, Thiel DD. Botulinum a toxin/dimethyl sulfoxide bladder instillations for women with refractory idiopathic detrusor overactivity: a phase 1/2 study. Mayo Clin Proc. 2009 Aug;84(8):702-6. doi: 10.4065/84.8.702.

  PMID: 19648387 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence, Urge; Urinary Incontinence

Interventions

Botulinum Toxins, Type A; Dimethyl Sulfoxide

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urination Disorders

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; Sulfoxides; Sulfur Compounds; Organic Chemicals

Results Point of Contact

• Title: Dr. Steven P. Petrou
• Organization: Mayo Clinic

peterou.steven@mayo.edu

904-953-7330

Study Officials

• Steven P Petrou, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 23, 2008
• First Posted: April 25, 2008
• Study Start: April 1, 2008
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: July 11, 2014
• Results First Posted: July 11, 2014

Record last verified: 2014-07

Locations

US (1)