TABLE 1.

Standardization of training and protocols

• Prior to centralized training, interventionists reviewed and were tested (80% correct responses required on all written tests to pass) on:

○ The ESTEEM protocol.

○ The Interventionist Manual of Treatment (IMOT). This manual was developed for ESTEEM and includes details of all procedures to be performed at each visit. It also defines situations that would be classified as a protocol deviation.

○ E-learning modules (completion verified by data coordinating center).

○ Bladder diary review, voiding interval calculations with online case modules.

• The IMOT includes detailed:

○ PFM exercise progression and BT procedures based on study visit.

○ Protocol for individualizing the PFM exercise progression or when “special circumstances” (ie, weak PFMs, inability to relax PFMs following a contraction) are encountered.

○ Specific recommendations to promote adherence to PFM exercise and/or behavioral strategy recommendations when identified on the ESTEEM behavioral adherence questionnaire.

• During each intervention visit, a checklist of protocol elements is used by the interventionists to prevent protocol drift.

• Interventionists are required to use the Behavioral Skills and Treatment Booklet for participant education on the 4 behavioral components (PFM exercise, BT with urge suppression strategies, stress strategies, and healthy voiding habits); and when prescribing the specific PFM exercise progression, BT and voiding interval, behavioral strategies (urge suppression, “Knack” or “stress strategy,” and normal voiding techniques.

• Audiotaping of all intervention sessions with a subset audited by behavioral therapy experts to ensure protocol adherence. Protocol deviations will be addressed as necessary.

• Phone calls between interventionists and behavioral experts will take place as needed to ensure protocol adherence and to discuss interventionists concerns and/or questions as they arise.