Botulin-A Toxin Instillations and Overactive Bladder

NCT00583219 | Completed Phase 1 Results

• 1 other identifier: 359-06
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this pilot study is to evaluate the safety and efficacy of direct instillations of Botulinum-A toxin/DMSO into the bladder via a catheter system as a means of treating women with symptoms of overactive bladder and secondary urinary incontinence. In doing so, we will focus on estimating the percentage of women who experience an improvement in their urinary incontinence symptoms at one month and three months following this novel instillation technique.

Conditions

Overactive Bladder; Detrusor Instability; Detrusor Hyperreflexia

Outcome Measures

Primary Outcomes (1)

• Median Number of Incontinent Episodes During 24 Hours

  The study coordinator instructed the subject to keep record of any incontinence episodes during the 24-hour period prior to their baseline and follow-up visits.

  baseline, 1 month, 3 months

Secondary Outcomes (13)

• Median 24 Hour Pad Weight

  baseline, 1 month, 3 months

• Blaivas-Groutz Anti-Incontinence Score at Baseline

  baseline

• Blaivas-Groutz Anti-Incontinence Score at 1 Month

  1 month after treatment

• Blaivas-Groutz Anti-Incontinence Score at 3 Months

  3 months after treatment

• Mean Number of Pads Per Day

  baseline, 1 month, 3 months

Study Arms (1)

Botox/DMSO Solution

EXPERIMENTAL

Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO. All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.

Drug: Botulinum-A toxin; Drug: Dimethyl sulfoxide (DMSO)

Interventions

Botulinum-A toxin DRUG

A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.

Also known as: Botox, Dysport, Xeomin

Botox/DMSO Solution

Dimethyl sulfoxide (DMSO) DRUG

Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO.

Botox/DMSO Solution

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
• Patient with a history of stress urinary incontinence for at least 12 months
• Patient with Intrinsic Sphincter Deficiency who demonstrate an abdominal leak point pressure of less than 100 cm of water on urodynamic evaluation
• Patient with urinary incontinence verified by the Provocation test: a mean urinary leakage of 10 g on screening and baseline visits
• Patient with positive stress test and/or urodynamic stress incontinence
• Patient who has failed prior non-invasive treatment (e.g. behavior modification, pelvic floor exercises, biofeedback, electrical stimulation and/or drug therapy)
• Patient with negative Contigen skin test during screening.
• 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 Q-tip angle greater than 30 degrees
• Patient with Functional Bladder capacity \<200 ml as recorded in the baseline Bladder Diary
• 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 vesicoureteral reflux, interstitial cystitis, genitourinary fistulae
• Patient with predominant urge incontinence
• Patient with detrusor overactivity on filling cystometry
• 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 urinary incontinence due to neurological disease that is known to affect urinary tract infection
• Patient with uninvestigated hematuria
• Patient with 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 who has had bulking therapy for stress urinary incontinence
• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Jacksonville

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 RESULT

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Botulinum Toxins, Type A; abobotulinumtoxinA; incobotulinumtoxinA; 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

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

petrou.steven@mayo.edu

904-953-7330

Study Officials

• Steven Petrou, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: December 31, 2007
• Study Start: March 1, 2006
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: April 21, 2014
• Results First Posted: April 21, 2014

Record last verified: 2014-03

Locations

US (1)