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Botox as a Treatment for Interstitial Cystitis in Women

Primary Purpose

Painful Bladder Syndrome, Interstitial Cystitis

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Botox
normal saline
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Painful Bladder Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Women ages 18 and older Diagnosis of interstitial cystitis Subject has severity/stage of disease: at least 12 voids/day with the presence of pelvic pain Ability to follow study instructions and likely to complete all required visits. Negative urine pregnancy test on the day of treatment prior to the administration of study medication (for females of childbearing potential; if applicable) Exclusion Criteria: Use of any medications that might interfere with neuromuscular function Any medical condition that may put the subject at increased risk with exposure to Botox including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other disorder that might interfere with neuromuscular function Females who are pregnant, breast-feeding, or planning a pregnancy during the study or who think that they may be pregnant at the start of the study, or females of childbearing potential who are unable or unwilling to use a reliable form of contraception during the study Known allergy or sensitivity to any of the components in the study medication Concurrent participation in another investigational drug or device study, or participation in the 30 days immediately prior to study enrollment. Stress incontinence Urinary tract infection at time of enrollment Overtly psychotic or suicidal Pain from another source in the genital tract such as kidney stones or neoplasm Having had radiation therapy History of genitourinary tuberculosis Neurological abnormalities such as stroke, brain tumors, spinal cord injury and Parkinson's or Alzheimer's disease Currently taking antibiotics

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Botox injection

    Normal saline

    Arm Description

    Subjects were injected with Botulinum toxin A in a mix of 50 U diluted in 2 cubic centimeters of normal saline. With the subjects in the dorsal lithotomy position, one injection of 25 international units was given into the bladder neck at the 3 o'clock position and another of 25 international units was given into the 9 o'clock position

    Subjects were injected in the bladder neck with 1 cubic centimeter normal saline into the 3 o'clock and 6 o' clock positions in the perineum, while in the dorsal lithotomy position

    Outcomes

    Primary Outcome Measures

    Chronic Prostatitis Symptom Index (CPSI-F)
    CPSI-F was adapted from the CPSI, in order to document the location of pain, with working pertinent to female anatomy. The CPSI-F was scored on a range of 0-83 (0-61 in the pain domain, 0-10 in the urination domain, 0-6 in the impact of symptoms domain, and 0-6 in the quality of life domain), with higher scores denoting worse symptoms.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 13, 2005
    Last Updated
    September 12, 2012
    Sponsor
    University of Washington
    Collaborators
    Paul G. Allen Family Foundation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00194610
    Brief Title
    Botox as a Treatment for Interstitial Cystitis in Women
    Official Title
    Botox (Botulinum Toxin A) as a Treatment for Interstitial Cystitis in Women: A Randomized Placebo Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2004 (undefined)
    Primary Completion Date
    June 2009 (Actual)
    Study Completion Date
    September 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Washington
    Collaborators
    Paul G. Allen Family Foundation

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Patients with interstitial cystitis have been well documented to have pelvic floor muscle tenderness as well as pain on bladder distension. Some investigators have even suggested that pelvic floor muscle pain is primarily the cause of bladder problems. Botulinum toxin A causes muscle relaxation by inhibiting the acetylcholine release at the neuromuscular junction. It has been shown that this mechanism relieves pain in a number of muscle spasm-related syndromes. Because, at present, there is little effective therapy available for patients with interstitial cystitis, the researchers want to determine if botulinum toxin A will relieve bladder and pelvic pain in these patients.
    Detailed Description
    Screening Visit: After being screened by her medical provider, the patient will be given the opportunity to ask questions about the study. She will then be asked to read and sign the consent and then be randomized. Then, for women of childbearing age, a pregnancy test will be done. Next, we will ask the patient to fill out baseline study forms and she will be given a Voiding Diary. She will also be asked to provide a urine sample which will be processed for chemistry and culture. Injection Visit: This visit will be scheduled one week after the Screening Visit. First, a standard history and physical will be done. Then the clinician will proceed with the injection. The subject will receive an injection of not more than 5 ml of 1% lidocaine without epinephrine at the site of the botulinum toxin A injection. Next, 25 units of Botox will be injected, via the transvaginal route, on either side of the bladder neck. The remaining 50 units will be injected (in 2 - 25 unit doses) into other pelvic sites that the patient has identified as tender during the patient examination. 1 Month Post Injection Mailing: The patient will be mailed a packet containing follow-up questionnaires and asked to mail them back upon completion. 6 Week Urine Collection Visit: Two weeks after receiving her study injection, we will ask the patient to go to the Urology Clinic and provide a urine sample. 2 Month Post Injection Mailing: Same as 1 Month Post Injection Visit. 3 Month Post Visit: The subject will be asked to fill out follow-up questionnaires and will be asked to turn in her last set of Voiding Diaries.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Painful Bladder Syndrome, Interstitial Cystitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Botox injection
    Arm Type
    Experimental
    Arm Description
    Subjects were injected with Botulinum toxin A in a mix of 50 U diluted in 2 cubic centimeters of normal saline. With the subjects in the dorsal lithotomy position, one injection of 25 international units was given into the bladder neck at the 3 o'clock position and another of 25 international units was given into the 9 o'clock position
    Arm Title
    Normal saline
    Arm Type
    Placebo Comparator
    Arm Description
    Subjects were injected in the bladder neck with 1 cubic centimeter normal saline into the 3 o'clock and 6 o' clock positions in the perineum, while in the dorsal lithotomy position
    Intervention Type
    Drug
    Intervention Name(s)
    Botox
    Other Intervention Name(s)
    Botulinum Toxin A
    Intervention Description
    Botox 25 international units per injection injected in two places in the bladder neck, with option to inject two other tender points with 25 units each
    Intervention Type
    Other
    Intervention Name(s)
    normal saline
    Intervention Description
    Normal saline injected into the bladder neck via the perineum, 1 cc each given at positions 3 o'clock and 9 o'clock
    Primary Outcome Measure Information:
    Title
    Chronic Prostatitis Symptom Index (CPSI-F)
    Description
    CPSI-F was adapted from the CPSI, in order to document the location of pain, with working pertinent to female anatomy. The CPSI-F was scored on a range of 0-83 (0-61 in the pain domain, 0-10 in the urination domain, 0-6 in the impact of symptoms domain, and 0-6 in the quality of life domain), with higher scores denoting worse symptoms.
    Time Frame
    3 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Women ages 18 and older Diagnosis of interstitial cystitis Subject has severity/stage of disease: at least 12 voids/day with the presence of pelvic pain Ability to follow study instructions and likely to complete all required visits. Negative urine pregnancy test on the day of treatment prior to the administration of study medication (for females of childbearing potential; if applicable) Exclusion Criteria: Use of any medications that might interfere with neuromuscular function Any medical condition that may put the subject at increased risk with exposure to Botox including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other disorder that might interfere with neuromuscular function Females who are pregnant, breast-feeding, or planning a pregnancy during the study or who think that they may be pregnant at the start of the study, or females of childbearing potential who are unable or unwilling to use a reliable form of contraception during the study Known allergy or sensitivity to any of the components in the study medication Concurrent participation in another investigational drug or device study, or participation in the 30 days immediately prior to study enrollment. Stress incontinence Urinary tract infection at time of enrollment Overtly psychotic or suicidal Pain from another source in the genital tract such as kidney stones or neoplasm Having had radiation therapy History of genitourinary tuberculosis Neurological abnormalities such as stroke, brain tumors, spinal cord injury and Parkinson's or Alzheimer's disease Currently taking antibiotics
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Claire Yang, MD
    Organizational Affiliation
    University of Washington
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Botox as a Treatment for Interstitial Cystitis in Women

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