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 technique.13
• Medication administered on back-to-back days
• Total of 0.9 mg administered with each series, diluted to 0.8 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 partner's 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.