Ignite Creation Date:
2024-10-25 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06649539
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-12
Brief Title:
Delayed Dose Collagenase Clostridium Histolyticum CCH Protocol for Men With Peyronies Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy of a Step-wise Protocol in Optimizing CCH Outcomes in Men With Peyronies Disease
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Our team has previously demonstrated efficacy in performing a novel collagenase Clostridium histolyticum CCH injection protocol in men who previously failed to achieve a response to an initial 4 series of CCH
The objective of the current study is to evaluate a protocol that incorporates limited in-office modeling for up to 4 series followed by up to 2 additional salvage series to determine safety and efficacy compared to historical data
Participants will receive up to 4 series of CCH injections using our previously published protocol with mild in-office modeling CCH injections are given on back-to back days after which they are counseled to utilize Restorex and sildenafil daily as instructed Patients will undergo mild in-office modeling on day 2
The sexual partners of study participants will also be invited to enroll in the study and will complete non-validated questionnaires detailing their level of support for the patients treatment
The objective of the current study is to evaluate a protocol that incorporates limited in-office modeling for up to 4 series followed by up to 2 additional salvage series to determine safety and efficacy compared to historical data
Participants will receive up to 4 series of CCH injections using our previously published protocol with mild in-office modeling CCH injections are given on back-to back days after which they are counseled to utilize Restorex and sildenafil daily as instructed Patients will undergo mild in-office modeling on day 2
The sexual partners of study participants will also be invited to enroll in the study and will complete non-validated questionnaires detailing their level of support for the patients treatment
Detailed Description:
The current study would prospectively follow 40 men through the following treatment protocol
Men would receive 4 series of CCH injections according to the protocol below which represents a modified version of our most recently published technique13
Medication administered on back-to-back days
Total of 09 mg administered with each series diluted to 08 mL
Mild in-office modeling performed on treatment day 2 of each series
Wraps performed ranging from 2-4 full-time and 2-4 part-time days to minimize bruising
Sildenafil 25 mg nightly beginning treatment day 2 until 6 weeks after final injection of the final series
Restorex initiated beginning on post-injection day 3 or as soon as tolerated - 30 min daily continuing until 6 weeks after final injection of the final series
Note that men may stop sooner if they are satisfied before completing the 4 series
If the patient is not satisfied with outcomes by the end of the 4th series they would be permitted to enter the salvage phase of the treatment protocol
This would be performed 9-12 months after the 4th series of injections
The technique would be similar to the one noted above with the exception of more aggressive in-office modeling as described in our prior publication and per our ongoing randomized trial
The men would receive up to two additional series per this protocol for a maximum number of cycles being 6 in total
At the time of initial enrollment partners of study participants will be invited to enroll in the study and will be administered non-validated questionnaires designed to assess the partners overall support for the ongoing treatment protocol
Assessments and study questionnaires will be administered at baseline with the 1st injection of each series 6 weeks after completing the 4th series of CCH injections and 1 year after completion of the final series of CCH injections
Men would receive 4 series of CCH injections according to the protocol below which represents a modified version of our most recently published technique13
Medication administered on back-to-back days
Total of 09 mg administered with each series diluted to 08 mL
Mild in-office modeling performed on treatment day 2 of each series
Wraps performed ranging from 2-4 full-time and 2-4 part-time days to minimize bruising
Sildenafil 25 mg nightly beginning treatment day 2 until 6 weeks after final injection of the final series
Restorex initiated beginning on post-injection day 3 or as soon as tolerated - 30 min daily continuing until 6 weeks after final injection of the final series
Note that men may stop sooner if they are satisfied before completing the 4 series
If the patient is not satisfied with outcomes by the end of the 4th series they would be permitted to enter the salvage phase of the treatment protocol
This would be performed 9-12 months after the 4th series of injections
The technique would be similar to the one noted above with the exception of more aggressive in-office modeling as described in our prior publication and per our ongoing randomized trial
The men would receive up to two additional series per this protocol for a maximum number of cycles being 6 in total
At the time of initial enrollment partners of study participants will be invited to enroll in the study and will be administered non-validated questionnaires designed to assess the partners overall support for the ongoing treatment protocol
Assessments and study questionnaires will be administered at baseline with the 1st injection of each series 6 weeks after completing the 4th series of CCH injections and 1 year after completion of the final series of CCH injections
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