Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Long-Term Effectiveness Of Sacrospinous Ligament Fixation vs Uterosacral Ligament Suspension With and Without Perioperative Behavioral Therapy/Pelvic Muscle Training: Extended Operations & Pelvic Muscle Training Of Apical Support Loss Study
Brief Summary: Women will be invited to participate in E-OPTIMAL at their last clinical follow-up visit for OPTIMAL (at 24 months post surgery). E-OPTIMAL is an extension of the ongoing OPTIMAL study and no new study treatment interventions will be given. Rather an enrollment intervention will be investigated with potential E-OPTIMAL participants randomly assigned to watch a standardized video prior to consent or undergo the standard informed consent process. The standardized video will review the rationale for women's health research, the importance of long-term follow-up and a detailed invitation to participate in E-OPTIMAL. The video has undergone review by potential subjects, coordinators and physician researchers to ensure that the relevance and importance of issues potentially impacting on long-term participation in studies such as E-OPTIMAL are covered. Participation in E-OPTIMAL will occur up to three additional years. Women will be strongly encouraged to participate in annual examinations and annual telephone surveys but may participate in only one of these study parts if needed.

We propose to test the following null hypotheses:

1. There will be no difference in time to surgical failure between uterosacral vaginal vault ligament suspension (ULS) and sacrospinous ligament fixation (SSLF) up to 5 years after surgery.
2. The addition of a standardized video detailing the importance of long-term follow-up studies for POP to the informed consent process will not improve enrollment or retention in E-OPTIMAL.


Options:
A: Arm Label: Enrollment video arm; Type: EXPERIMENTAL; Interventions: Behavioral: Enrollment video | Arm Label: No video intervention arm; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: ULS; Type: EXPERIMENTAL; Interventions: Procedure: ULS | Arm Label: SSLF; Type: EXPERIMENTAL; Interventions: Procedure: SSLF | Arm Label: PMT; Type: EXPERIMENTAL; Interventions: Behavioral: PMT | Arm Label: Usual Care; Type: OTHER; Interventions: Other: Usual Care | Intervention Type: BEHAVIORAL; Name: Enrollment video; Assigned to Arm(s): Enrollment video arm | Intervention Type: PROCEDURE; Name: SSLF; Assigned to Arm(s): SSLF | Intervention Type: PROCEDURE; Name: ULS; Assigned to Arm(s): ULS | Intervention Type: BEHAVIORAL; Name: PMT; Assigned to Arm(s): PMT | Intervention Type: OTHER; Name: Usual Care; Assigned to Arm(s): Usual Care
B: Arm Label: Usual Care; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Auto Plus; Type: ACTIVE_COMPARATOR; Interventions: Other: Auto Plus | Intervention Type: OTHER; Name: Auto Plus; Assigned to Arm(s): Auto Plus
C: Arm Label: Control Group; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Intervention Group I; Type: EXPERIMENTAL; Interventions: Behavioral: self-regulation | Intervention Type: BEHAVIORAL; Name: self-regulation; Assigned to Arm(s): Intervention Group I
D: Arm Label: Intervention group 1; Type: EXPERIMENTAL; Interventions: Behavioral: HPV self-sampling kit mailed directly | Arm Label: Intervention group 2; Type: EXPERIMENTAL; Interventions: Behavioral: HPV self-sampling kit on demand | Arm Label: Intervention group 3; Type: EXPERIMENTAL; Interventions: Behavioral: Second reminder | Intervention Type: BEHAVIORAL; Name: HPV self-sampling kit mailed directly; Assigned to Arm(s): Intervention group 1 | Intervention Type: BEHAVIORAL; Name: HPV self-sampling kit on demand; Assigned to Arm(s): Intervention group 2 | Intervention Type: BEHAVIORAL; Name: Second reminder; Assigned to Arm(s): Intervention group 3

Answer: A