Painful Bladder SyndromePhase 4NCT00194610
Botox as a Treatment for Interstitial Cystitis in Women
A Phase 4 study testing Botox and normal saline in people with Painful Bladder Syndrome and Interstitial Cystitis, run by University of Washington.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Painful Bladder Syndrome, Interstitial Cystitis
- What is being tested?
- Botox and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- May 2004to Sep 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 13Show fewer
- 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
About this study
Official title: Botox (Botulinum Toxin A) as a Treatment for Interstitial Cystitis in Women: A Randomized Placebo Controlled Trial
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.
Read the 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.
- Conditions
- Painful Bladder Syndrome, Interstitial Cystitis
- Being tested
- Botox, normal saline
- Medical subject headings
- Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BotoxDrug
Also called Botulinum Toxin A
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
normal salineOther
Normal saline injected into the bladder neck via the perineum, 1 cc each given at positions 3 o'clock and 9 o'clock
| Study group | Role | What they receive |
|---|---|---|
| Botox injection | Experimental | 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 Receives: Drug: Botox |
| Normal saline | Placebo comparator | 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 Receives: Other: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startMay 2004
- Primary completionJun 2009
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Painful Bladder SyndromeStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Paul G. Allen Family Foundation
- Responsible party
- Sponsor
- Investigators
- Claire Yang, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00194610
- Sponsor's protocol ID
- 25398-D
- Status last verified
- Sep 2012
- First submitted
- 13 Sep 2005
- Last updated
- 12 Oct 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Botox (Botulinum Toxin A) as a Treatment for Interstitial Cystitis in Women: A Randomized Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT00194610
- Acronym / sponsor ID
- 25398-D
- Conditions
- Painful Bladder Syndrome, Interstitial Cystitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Paul G. Allen Family Foundation
- Study start
- May 2004
- Primary completion
- Jun 2009 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 19 Sep 2005 (estimated)
- Results
- Posted 12 Oct 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Botox injection | Experimental | Drug: BotoxSubjects 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 |
| Normal saline | Placebo comparator | Other: normal salineSubjects 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BotoxAlso: Botulinum Toxin ABotox 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 | Drug | Botox injection |
| normal salineNormal saline injected into the bladder neck via the perineum, 1 cc each given at positions 3 o'clock and 9 o'clock | Other | Normal saline |
Primary outcome
Chronic Prostatitis Symptom Index (CPSI-F)
Time frame: 3 months
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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EPPIC: Easing Pelvic Pain Interventions Clinical Research Program
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claire Yang, MD principal investigator
University of Washington
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Botox and normal saline in people with Painful Bladder Syndrome and Interstitial Cystitis, run by University of Washington.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic Prostatitis Symptom Index (CPSI-F) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2012.