Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00194610
Status:
COMPLETED
Last Update Posted:
2012-10-12
First Post:
2005-09-13
Brief Title:
Botox as a Treatment for Interstitial Cystitis in Women
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Botox Botulinum Toxin A as a Treatment for Interstitial Cystitis in Women A Randomized Placebo Controlled Trial
Status:
COMPLETED
Status Verified Date:
2012-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None