Trial Outcomes & Findings for The Extended Operations And Pelvic Muscle Training In The Management Of Apical Support Loss Study (NCT NCT01166373)

Last Updated: 2020-09-28

Results Overview

Surgical failure was defined as Pelvic Organ Prolapse Quantification (POP-Q) point C descended more than one-third of total vaginal length; POPQ points Aa, Ba, Ap, or Bp were beyond the hymen; bothersome vaginal bulge symptoms were reported by the participant; or the participant received retreatment. The apex is point C (cervix), and posteriorly is point D (pouch of Douglas). In women after hysterectomy, point C is the vaginal cuff and point D is omitted. This outcome measure is cumulatively across the original OPTIMAL trial and continued through the E-OPTIMAL follow-up with non-failures tracked either until failure or until study completion/dropping out of the study (lost to follow-up, withdrawal, etc.)

Recruitment status

COMPLETED

Study phase

Target enrollment

285 participants

Primary outcome timeframe

6 months and 1, 2, 3, 4, and 5 years

Results posted on

2020-09-28

Participant Flow

The goal of the video/no video intervention was to gauge differences in recruitment for and retention in E-OPTIMAL, thus the video/no video randomization occurred before E-OPTIMAL consent.

Treatment groups are from the original OPTIMAL trial. Participants in the E-OPTIMAL trial were recruited from OPTIMAL participants that completed the Year 2 OPTIMAL visit.

Participant milestones

Participant milestones
Measure	SSLF+BPMT Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training	SSLF+USUAL Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training	ULS+BPMT Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training	ULS+USUAL Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
Overall Study STARTED	95	91	91	97
Overall Study Completed OPTIMAL Year 2 Visit	81	80	79	87
Overall Study Randomized to Video	32	43	38	40
Overall Study Randomized to No Video	45	30	34	42
Overall Study Consented to Participate E-OPTIMAL	72	66	69	78
Overall Study Completed E-OPTIMAL Year 3 Visit	70	66	66	77
Overall Study Completed E-OPTIMAL Year 4 Visit	67	61	63	68
Overall Study Completed E-OPTIMAL Year 5 Visit	62	56	62	64
Overall Study COMPLETED	90	87	87	92
Overall Study NOT COMPLETED	5	4	4	5

Reasons for withdrawal

Reasons for withdrawal
Measure	SSLF+BPMT Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training	SSLF+USUAL Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training	ULS+BPMT Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training	ULS+USUAL Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
Overall Study Lost to Follow-up	3	2	2	2
Overall Study Withdrawal by Subject	1	2	2	3
Overall Study Physician Decision	1	0	0	0

Baseline Characteristics

The Extended Operations And Pelvic Muscle Training In The Management Of Apical Support Loss Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SSLF+BPMT n=72 Participants Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training	SSLF+USUAL n=66 Participants Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training	ULS+BPMT n=69 Participants Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training	ULS+USUAL n=78 Participants Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training	Total n=285 Participants Total of all reporting groups
Age, Continuous	55.4 years STANDARD_DEVIATION 10.8 • n=5 Participants	58.6 years STANDARD_DEVIATION 10.6 • n=7 Participants	58.7 years STANDARD_DEVIATION 10.5 • n=5 Participants	56.3 years STANDARD_DEVIATION 11.2 • n=4 Participants	57.2 years STANDARD_DEVIATION 10.8 • n=21 Participants
Sex/Gender, Customized Female	72 Participants n=5 Participants	66 Participants n=7 Participants	69 Participants n=5 Participants	78 Participants n=4 Participants	285 Participants n=21 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Race/Ethnicity, Customized Black or African American	7 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants	4 Participants n=4 Participants	21 Participants n=21 Participants
Race/Ethnicity, Customized Other	5 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	8 Participants n=4 Participants	22 Participants n=21 Participants
Race/Ethnicity, Customized White	59 Participants n=5 Participants	55 Participants n=7 Participants	58 Participants n=5 Participants	66 Participants n=4 Participants	238 Participants n=21 Participants
Race/Ethnicity, Customized Hispanic/Latina	15 Participants n=5 Participants	10 Participants n=7 Participants	13 Participants n=5 Participants	18 Participants n=4 Participants	56 Participants n=21 Participants
Race/Ethnicity, Customized Not Hispanic/Latina	57 Participants n=5 Participants	56 Participants n=7 Participants	56 Participants n=5 Participants	60 Participants n=4 Participants	229 Participants n=21 Participants
Insurance: Private/HMO No	70 Participants n=5 Participants	65 Participants n=7 Participants	68 Participants n=5 Participants	76 Participants n=4 Participants	279 Participants n=21 Participants
Insurance: Private/HMO Yes	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	6 Participants n=21 Participants
Insurance: Medicare or Medicaid No	55 Participants n=5 Participants	46 Participants n=7 Participants	47 Participants n=5 Participants	56 Participants n=4 Participants	204 Participants n=21 Participants
Insurance: Medicare or Medicaid Yes	17 Participants n=5 Participants	20 Participants n=7 Participants	22 Participants n=5 Participants	22 Participants n=4 Participants	81 Participants n=21 Participants
Insurance: Self-pay No	70 Participants n=5 Participants	65 Participants n=7 Participants	68 Participants n=5 Participants	76 Participants n=4 Participants	279 Participants n=21 Participants
Insurance: Self-pay Yes	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	6 Participants n=21 Participants
Insurance: Other No	57 Participants n=5 Participants	55 Participants n=7 Participants	59 Participants n=5 Participants	60 Participants n=4 Participants	231 Participants n=21 Participants
Insurance: Other Yes	15 Participants n=5 Participants	11 Participants n=7 Participants	10 Participants n=5 Participants	18 Participants n=4 Participants	54 Participants n=21 Participants
Body Mass Index	30.2 kg/m^2 STANDARD_DEVIATION 6.5 • n=5 Participants	28.2 kg/m^2 STANDARD_DEVIATION 5.3 • n=7 Participants	28.8 kg/m^2 STANDARD_DEVIATION 4.9 • n=5 Participants	28.3 kg/m^2 STANDARD_DEVIATION 5.2 • n=4 Participants	28.9 kg/m^2 STANDARD_DEVIATION 5.5 • n=21 Participants
Current Smoker No	64 Participants n=5 Participants	61 Participants n=7 Participants	64 Participants n=5 Participants	73 Participants n=4 Participants	262 Participants n=21 Participants
Current Smoker Yes	8 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	5 Participants n=4 Participants	23 Participants n=21 Participants
Diabetes Unknown	4 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	7 Participants n=21 Participants
Diabetes No	59 Participants n=5 Participants	59 Participants n=7 Participants	58 Participants n=5 Participants	72 Participants n=4 Participants	248 Participants n=21 Participants
Diabetes Yes	9 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants	5 Participants n=4 Participants	30 Participants n=21 Participants
Connective tissue disease Unknown	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants	5 Participants n=21 Participants
Connective tissue disease No	70 Participants n=5 Participants	65 Participants n=7 Participants	68 Participants n=5 Participants	72 Participants n=4 Participants	275 Participants n=21 Participants
Connective tissue disease Yes	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	5 Participants n=21 Participants
Number of Vaginal Deliveries	3 Deliveries n=5 Participants	2 Deliveries n=7 Participants	3 Deliveries n=5 Participants	3 Deliveries n=4 Participants	3 Deliveries n=21 Participants
Number of Cesarean Deliveries	0 Deliveries n=5 Participants	0 Deliveries n=7 Participants	0 Deliveries n=5 Participants	0 Deliveries n=4 Participants	0 Deliveries n=21 Participants
Estrogen Use: Oral or patch No	63 Participants n=5 Participants	56 Participants n=7 Participants	60 Participants n=5 Participants	70 Participants n=4 Participants	249 Participants n=21 Participants
Estrogen Use: Oral or patch Yes	9 Participants n=5 Participants	10 Participants n=7 Participants	9 Participants n=5 Participants	8 Participants n=4 Participants	36 Participants n=21 Participants
Estrogen Use: Vaginal cream or tablets No	59 Participants n=5 Participants	50 Participants n=7 Participants	49 Participants n=5 Participants	60 Participants n=4 Participants	218 Participants n=21 Participants
Estrogen Use: Vaginal cream or tablets Yes	13 Participants n=5 Participants	16 Participants n=7 Participants	20 Participants n=5 Participants	18 Participants n=4 Participants	67 Participants n=21 Participants
Menstrual Status Not sure	5 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	15 Participants n=21 Participants
Menstrual Status Postmenopausal	42 Participants n=5 Participants	48 Participants n=7 Participants	49 Participants n=5 Participants	49 Participants n=4 Participants	188 Participants n=21 Participants
Menstrual Status premenopausal	25 Participants n=5 Participants	14 Participants n=7 Participants	17 Participants n=5 Participants	26 Participants n=4 Participants	82 Participants n=21 Participants
Hysterectomy No	58 Participants n=5 Participants	42 Participants n=7 Participants	52 Participants n=5 Participants	59 Participants n=4 Participants	211 Participants n=21 Participants
Hysterectomy Yes	14 Participants n=5 Participants	24 Participants n=7 Participants	17 Participants n=5 Participants	19 Participants n=4 Participants	74 Participants n=21 Participants
Prior SUI Surgery No	71 Participants n=5 Participants	62 Participants n=7 Participants	67 Participants n=5 Participants	75 Participants n=4 Participants	275 Participants n=21 Participants
Prior SUI Surgery Yes	1 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	10 Participants n=21 Participants
Prior POP Surgery No	68 Participants n=5 Participants	58 Participants n=7 Participants	67 Participants n=5 Participants	74 Participants n=4 Participants	267 Participants n=21 Participants
Prior POP Surgery Yes	4 Participants n=5 Participants	8 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants	18 Participants n=21 Participants
Pelvic Organ Prolapse-Q stage 2	27 Participants n=5 Participants	23 Participants n=7 Participants	26 Participants n=5 Participants	31 Participants n=4 Participants	107 Participants n=21 Participants
Pelvic Organ Prolapse-Q stage 3	43 Participants n=5 Participants	37 Participants n=7 Participants	41 Participants n=5 Participants	45 Participants n=4 Participants	166 Participants n=21 Participants
Pelvic Organ Prolapse-Q stage 4	2 Participants n=5 Participants	6 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	12 Participants n=21 Participants

PRIMARY outcome

Timeframe: 6 months and 1, 2, 3, 4, and 5 years

Population: The primary analysis was conducted using an intention-to-treat principle as closely as possible by analyzing all successfully followed up participants in the OPTIMAL treatment group to which they were randomized.

Outcome measures

Outcome measures
Measure	SSLF+BPMT n=90 Participants Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training	SSLF+USUAL n=87 Participants Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training	ULS+BPMT n=87 Participants Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training	ULS+USUAL n=92 Participants Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
Surgical Failure 0.5 years · Failure	17 Participants	22 Participants	20 Participants	14 Participants
Surgical Failure 0.5 years · Non-failure	73 Participants	65 Participants	66 Participants	77 Participants
Surgical Failure 1 years · Failure	28 Participants	35 Participants	30 Participants	29 Participants
Surgical Failure 1 years · Non-failure	58 Participants	51 Participants	56 Participants	62 Participants
Surgical Failure 2 years · Failure	31 Participants	45 Participants	39 Participants	37 Participants
Surgical Failure 2 years · Non-failure	51 Participants	39 Participants	44 Participants	52 Participants
Surgical Failure 3 years · Failure	37 Participants	52 Participants	46 Participants	41 Participants
Surgical Failure 3 years · Non-failure	39 Participants	26 Participants	31 Participants	40 Participants
Surgical Failure 4 years · Failure	41 Participants	55 Participants	49 Participants	43 Participants
Surgical Failure 4 years · Non-failure	30 Participants	22 Participants	26 Participants	32 Participants
Surgical Failure 5 years · Failure	47 Participants	57 Participants	49 Participants	45 Participants
Surgical Failure 5 years · Non-failure	22 Participants	20 Participants	26 Participants	25 Participants

PRIMARY outcome

Timeframe: At 24 Months post OPTIMAL Treatment

Population: The objective of the Outcome Measure was to compare retention rates for the "Enrollment video arm" and "No video arm", and the OPTIMAL treatment received was not relevant to this analysis

Eligible OPTIMAL participants were to receive a video (or no video) about the importance of follow-up in clinical trials. The outcome is measured as the number of OPTIMAL participants that consented to participate in E-OPTIMAL.

Outcome measures

Outcome measures
Measure	SSLF+BPMT n=153 Participants Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training	SSLF+USUAL n=151 Participants Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training	ULS+BPMT Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training	ULS+USUAL Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
Recruitment Into E-OPTIMAL Consented to E-OPTIMAL	142 Participants	143 Participants	—	—
Recruitment Into E-OPTIMAL Did not Consent to E-OPTIMAL	11 Participants	8 Participants	—	—

PRIMARY outcome

Timeframe: 3, 4, and 5 Years Post OPTIMAL Treatment

Population: The objective of the Outcome Measure was to compare retention rates after consent into E-OPTIMAL for the "Enrollment video arm" and "No video arm", and the OPTIMAL treatment received was not relevant to this analysis

Retention is defined as those participants who consented to participate in E-OPTIMAL that remained in the E-OPTIMAL study (i.e. completed follow-up visits and were not otherwise dropped from the study).

Outcome measures

Outcome measures
Measure	SSLF+BPMT n=142 Participants Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training	SSLF+USUAL n=143 Participants Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training	ULS+BPMT Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training	ULS+USUAL Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
Retention in E-OPTIMAL 3-Year Follow-up · Retained	139 Participants	135 Participants	—	—
Retention in E-OPTIMAL 3-Year Follow-up · Not Retained	3 Participants	8 Participants	—	—
Retention in E-OPTIMAL 4-Year Follow-up · Retained	131 Participants	124 Participants	—	—
Retention in E-OPTIMAL 4-Year Follow-up · Not Retained	11 Participants	19 Participants	—	—
Retention in E-OPTIMAL 5-Year Follow-up · Retained	124 Participants	120 Participants	—	—
Retention in E-OPTIMAL 5-Year Follow-up · Not Retained	18 Participants	23 Participants	—	—

SECONDARY outcome

Timeframe: 6 months and 1, 2, 3, 4, and 5 years

Anatomic failure was defined as POPQ system point C descended more than one-third of total vaginal length; POPQ points Aa, Ba, Ap, or Bp were beyond the hymen; or the participant received retreatment during follow-up. This outcome measure is cumulative across the original OPTIMAL trial and continued through the E-OPTIMAL follow-up with non-failures tracked either until failure or until study completion/dropping out of the study (lost to follow-up, withdrawal, etc.)

Outcome measures

Outcome measures
Measure	SSLF+BPMT n=90 Participants Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training	SSLF+USUAL n=86 Participants Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training	ULS+BPMT n=86 Participants Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training	ULS+USUAL n=92 Participants Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
Anatomic Failure 5 years · Non-failure	28 Participants	26 Participants	34 Participants	31 Participants
Anatomic Failure 0.5 years · Failure	10 Participants	12 Participants	13 Participants	11 Participants
Anatomic Failure 0.5 years · Non-failure	80 Participants	74 Participants	72 Participants	80 Participants
Anatomic Failure 1 years · Failure	18 Participants	23 Participants	19 Participants	25 Participants
Anatomic Failure 1 years · Non-failure	67 Participants	61 Participants	65 Participants	66 Participants
Anatomic Failure 2 years · Failure	23 Participants	31 Participants	25 Participants	29 Participants
Anatomic Failure 2 years · Non-failure	59 Participants	50 Participants	55 Participants	58 Participants
Anatomic Failure 3 years · Failure	29 Participants	37 Participants	31 Participants	31 Participants
Anatomic Failure 3 years · Non-failure	46 Participants	33 Participants	40 Participants	47 Participants
Anatomic Failure 4 years · Failure	33 Participants	40 Participants	32 Participants	33 Participants
Anatomic Failure 4 years · Non-failure	36 Participants	29 Participants	36 Participants	38 Participants
Anatomic Failure 5 years · Failure	38 Participants	42 Participants	33 Participants	35 Participants

SECONDARY outcome

Timeframe: 6 months and 1, 2, 3, 4, and 5 years

Bothersome bulge symptoms were reported by the participant in response to the questions, 'Do you usually have a sensation of bulging or protrusion from the vaginal area?' or 'Do you usually have a bulge or something falling out that you can see or feel in the vaginal area?' on the Pelvic Floor Disorders Inventory. An answer of "Yes" to either question indicates a failure while an answer to "No" for both questions indicates a non-failure.This outcome measure is cumulative across the original OPTIMAL trial and continued through the E-OPTIMAL follow-up with non-failures tracked either until failure or until study completion/dropping out of the study (lost to follow-up, withdrawal, etc.)

Outcome measures

Outcome measures
Measure	SSLF+BPMT n=90 Participants Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training	SSLF+USUAL n=88 Participants Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training	ULS+BPMT n=87 Participants Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training	ULS+USUAL n=94 Participants Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
Bothersome Bulge Symptoms 0.5 years · Failure	10 Participants	12 Participants	8 Participants	5 Participants
Bothersome Bulge Symptoms 1 years · Failure	21 Participants	19 Participants	15 Participants	9 Participants
Bothersome Bulge Symptoms 0.5 years · Non-failure	80 Participants	73 Participants	76 Participants	88 Participants
Bothersome Bulge Symptoms 1 years · Non-failure	68 Participants	64 Participants	67 Participants	81 Participants
Bothersome Bulge Symptoms 2 years · Failure	24 Participants	27 Participants	21 Participants	17 Participants
Bothersome Bulge Symptoms 2 years · Non-failure	61 Participants	56 Participants	58 Participants	69 Participants
Bothersome Bulge Symptoms 3 years · Failure	27 Participants	29 Participants	28 Participants	20 Participants
Bothersome Bulge Symptoms 3 years · Non-failure	47 Participants	45 Participants	43 Participants	55 Participants
Bothersome Bulge Symptoms 4 years · Failure	27 Participants	32 Participants	31 Participants	22 Participants
Bothersome Bulge Symptoms 4 years · Non-failure	45 Participants	40 Participants	39 Participants	46 Participants
Bothersome Bulge Symptoms 5 years · Failure	30 Participants	34 Participants	33 Participants	23 Participants
Bothersome Bulge Symptoms 5 years · Non-failure	36 Participants	34 Participants	35 Participants	42 Participants

SECONDARY outcome

Timeframe: 6 months and 1, 2, 3, 4, and 5 years

Retreatment is defined as any additional POP surgery or the use of pessary. This outcome measure is cumulative across the original OPTIMAL trial and continued through the E-OPTIMAL follow-up with non-retreatments tracked either until retreatment or until study completion/dropping out of the study (lost to follow-up, withdrawal, etc.)

Outcome measures

Outcome measures
Measure	SSLF+BPMT n=93 Participants Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training	SSLF+USUAL n=86 Participants Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training	ULS+BPMT n=86 Participants Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training	ULS+USUAL n=93 Participants Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
Retreatment for Pelvic Organ Prolapse 0.5 years · Retreated	1 Participants	0 Participants	1 Participants	0 Participants
Retreatment for Pelvic Organ Prolapse 0.5 years · Not retreated	90 Participants	86 Participants	82 Participants	92 Participants
Retreatment for Pelvic Organ Prolapse 1 years · Retreated	2 Participants	3 Participants	2 Participants	2 Participants
Retreatment for Pelvic Organ Prolapse 1 years · Not retreated	83 Participants	82 Participants	79 Participants	87 Participants
Retreatment for Pelvic Organ Prolapse 2 years · Retreated	5 Participants	3 Participants	6 Participants	2 Participants
Retreatment for Pelvic Organ Prolapse 2 years · Not retreated	76 Participants	77 Participants	73 Participants	85 Participants
Retreatment for Pelvic Organ Prolapse 3 years · Retreated	7 Participants	3 Participants	10 Participants	2 Participants
Retreatment for Pelvic Organ Prolapse 3 years · Not retreated	61 Participants	59 Participants	55 Participants	68 Participants
Retreatment for Pelvic Organ Prolapse 4 years · Retreated	7 Participants	4 Participants	10 Participants	5 Participants
Retreatment for Pelvic Organ Prolapse 4 years · Not retreated	52 Participants	51 Participants	52 Participants	52 Participants
Retreatment for Pelvic Organ Prolapse 5 years · Retreated	8 Participants	4 Participants	10 Participants	6 Participants
Retreatment for Pelvic Organ Prolapse 5 years · Not retreated	52 Participants	50 Participants	51 Participants	53 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 2, 3, 4, and 5 years

Population: An analysis which included all participants that completed the primary OPTIMAL trial though 2 years and who were consented to extended follow-up through 5 years.

Cumulative number of participants with granulation tissue. Granulation tissue was reported on the adverse event log.

Outcome measures

Outcome measures
Measure	SSLF+BPMT n=72 Participants Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training	SSLF+USUAL n=66 Participants Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training	ULS+BPMT n=69 Participants Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training	ULS+USUAL n=78 Participants Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
Number of Participants With Granulation Tissue 2 years · Yes	14 Participants	6 Participants	17 Participants	15 Participants
Number of Participants With Granulation Tissue 2 years · No	58 Participants	60 Participants	52 Participants	63 Participants
Number of Participants With Granulation Tissue 3 years · No	54 Participants	54 Participants	48 Participants	56 Participants
Number of Participants With Granulation Tissue 3 years · Yes	14 Participants	6 Participants	17 Participants	15 Participants
Number of Participants With Granulation Tissue 4 years · No	49 Participants	49 Participants	43 Participants	50 Participants
Number of Participants With Granulation Tissue 4 years · Yes	14 Participants	6 Participants	18 Participants	16 Participants
Number of Participants With Granulation Tissue 5 years · No	43 Participants	48 Participants	41 Participants	45 Participants
Number of Participants With Granulation Tissue 5 years · Yes	15 Participants	6 Participants	19 Participants	16 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 2, 3, 4, and 5 years

Population: An analysis which included all participants that completed the primary OPTIMAL trial though 2 years and who were consented to extended follow-up through 5 years.

Cumulative number of participants with suture exposure. Suture exposure was reported on the adverse event log.

Outcome measures

Outcome measures
Measure	SSLF+BPMT n=72 Participants Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training	SSLF+USUAL n=66 Participants Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training	ULS+BPMT n=69 Participants Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training	ULS+USUAL n=78 Participants Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
Number of Participants With Suture Exposure 2 years · No	57 Participants	55 Participants	60 Participants	60 Participants
Number of Participants With Suture Exposure 2 years · Yes	15 Participants	11 Participants	9 Participants	18 Participants
Number of Participants With Suture Exposure 3 years · No	53 Participants	50 Participants	57 Participants	52 Participants
Number of Participants With Suture Exposure 3 years · Yes	16 Participants	11 Participants	9 Participants	19 Participants
Number of Participants With Suture Exposure 4 years · No	49 Participants	44 Participants	51 Participants	46 Participants
Number of Participants With Suture Exposure 4 years · Yes	17 Participants	12 Participants	10 Participants	20 Participants
Number of Participants With Suture Exposure 5 years · No	42 Participants	42 Participants	49 Participants	40 Participants
Number of Participants With Suture Exposure 5 years · Yes	17 Participants	12 Participants	11 Participants	20 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 2, 3, 4, and 5 years

Population: An analysis which included all participants that completed the primary OPTIMAL trial though 2 years and who were consented to extended follow-up through 5 years.

Cumulative number of participants with mesh erosion or exposure. Mesh erosion and exposure was reported on the adverse event log.

Outcome measures

Outcome measures
Measure	SSLF+BPMT n=72 Participants Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training	SSLF+USUAL n=66 Participants Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training	ULS+BPMT n=69 Participants Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training	ULS+USUAL n=78 Participants Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
Number of Participants With Midurethral Sling Erosion or Exposure 2 years · No	70 Participants	66 Participants	68 Participants	78 Participants
Number of Participants With Midurethral Sling Erosion or Exposure 2 years · Yes	1 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Midurethral Sling Erosion or Exposure 3 years · No	65 Participants	59 Participants	63 Participants	70 Participants
Number of Participants With Midurethral Sling Erosion or Exposure 3 years · Yes	2 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Midurethral Sling Erosion or Exposure 4 years · No	60 Participants	53 Participants	58 Participants	63 Participants
Number of Participants With Midurethral Sling Erosion or Exposure 4 years · Yes	3 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Midurethral Sling Erosion or Exposure 5 years · No	53 Participants	51 Participants	54 Participants	57 Participants
Number of Participants With Midurethral Sling Erosion or Exposure 5 years · Yes	3 Participants	1 Participants	2 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 2, 3, 4, and 5 years

Population: An analysis which included all participants that completed the primary OPTIMAL trial though 2 years and who were consented to extended follow-up through 5 years.

Cumulative number of participants with pelvic organ prolapse. Pelvic organ prolapse was reported on the adverse event log.

Outcome measures

Outcome measures
Measure	SSLF+BPMT n=72 Participants Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training	SSLF+USUAL n=66 Participants Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training	ULS+BPMT n=69 Participants Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training	ULS+USUAL n=78 Participants Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
Number of Participants With Pelvic Organ Prolapse Surgery 4 years · No	55 Participants	51 Participants	55 Participants	53 Participants
Number of Participants With Pelvic Organ Prolapse Surgery 4 years · Yes	1 Participants	3 Participants	5 Participants	4 Participants
Number of Participants With Pelvic Organ Prolapse Surgery 2 years · No	72 Participants	64 Participants	67 Participants	76 Participants
Number of Participants With Pelvic Organ Prolapse Surgery 2 years · Yes	0 Participants	2 Participants	2 Participants	2 Participants
Number of Participants With Pelvic Organ Prolapse Surgery 3 years · No	64 Participants	59 Participants	58 Participants	68 Participants
Number of Participants With Pelvic Organ Prolapse Surgery 3 years · Yes	1 Participants	2 Participants	5 Participants	2 Participants
Number of Participants With Pelvic Organ Prolapse Surgery 5 years · No	55 Participants	50 Participants	54 Participants	54 Participants
Number of Participants With Pelvic Organ Prolapse Surgery 5 years · Yes	2 Participants	3 Participants	5 Participants	5 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months, and 1, 2, 3, 4, and 5 years

The Patient Global Impression of Improvement (PGI-I) is a patient-reported measure of perceived improvement with treatment, as assessed on a scale of 1 (very much better) to 7 (very much worse).This outcome measure is shows results from the original OPTIMAL trial as well as results from the E-OPTIMAL trial (for those that consented to the extended follow-up)

Outcome measures

Outcome measures
Measure	SSLF+BPMT n=72 Participants Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training	SSLF+USUAL n=66 Participants Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training	ULS+BPMT n=69 Participants Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training	ULS+USUAL n=78 Participants Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
PGI-I 0.5 years · A little better	12 Participants	11 Participants	10 Participants	12 Participants
PGI-I 0.5 years · A little worse	5 Participants	2 Participants	5 Participants	5 Participants
PGI-I 0.5 years · Much better	23 Participants	22 Participants	17 Participants	20 Participants
PGI-I 0.5 years · Much worse	1 Participants	1 Participants	1 Participants	1 Participants
PGI-I 0.5 years · No change	2 Participants	1 Participants	2 Participants	3 Participants
PGI-I 0.5 years · Very much better	26 Participants	26 Participants	29 Participants	31 Participants
PGI-I 0.5 years · Very much worse	0 Participants	1 Participants	1 Participants	2 Participants
PGI-I 1 years · A little better	13 Participants	10 Participants	6 Participants	6 Participants
PGI-I 1 years · A little worse	4 Participants	1 Participants	2 Participants	6 Participants
PGI-I 1 years · Much better	22 Participants	24 Participants	18 Participants	28 Participants
PGI-I 1 years · Much worse	0 Participants	0 Participants	1 Participants	0 Participants
PGI-I 1 years · No change	4 Participants	2 Participants	5 Participants	4 Participants
PGI-I 1 years · Very much better	26 Participants	25 Participants	30 Participants	27 Participants
PGI-I 1 years · Very much worse	1 Participants	0 Participants	2 Participants	1 Participants
PGI-I 2 years · A little better	14 Participants	14 Participants	9 Participants	13 Participants
PGI-I 2 years · A little worse	3 Participants	5 Participants	6 Participants	3 Participants
PGI-I 2 years · Much better	20 Participants	20 Participants	20 Participants	25 Participants
PGI-I 2 years · Much worse	3 Participants	0 Participants	0 Participants	1 Participants
PGI-I 2 years · No change	4 Participants	1 Participants	3 Participants	4 Participants
PGI-I 2 years · Very much better	21 Participants	21 Participants	25 Participants	23 Participants
PGI-I 2 years · Very much worse	1 Participants	0 Participants	2 Participants	1 Participants
PGI-I 3 years · A little better	5 Participants	19 Participants	10 Participants	13 Participants
PGI-I 3 years · A little worse	7 Participants	3 Participants	5 Participants	6 Participants
PGI-I 3 years · Much better	18 Participants	24 Participants	17 Participants	23 Participants
PGI-I 3 years · Much worse	6 Participants	2 Participants	0 Participants	3 Participants
PGI-I 3 years · No change	5 Participants	2 Participants	4 Participants	1 Participants
PGI-I 3 years · Very much better	23 Participants	10 Participants	21 Participants	21 Participants
PGI-I 3 years · Very much worse	0 Participants	0 Participants	3 Participants	1 Participants
PGI-I 4 years · A little better	9 Participants	14 Participants	7 Participants	16 Participants
PGI-I 4 years · A little worse	4 Participants	6 Participants	1 Participants	2 Participants
PGI-I 4 years · Much better	21 Participants	19 Participants	14 Participants	19 Participants
PGI-I 4 years · Much worse	4 Participants	1 Participants	4 Participants	1 Participants
PGI-I 4 years · No change	3 Participants	2 Participants	4 Participants	2 Participants
PGI-I 4 years · Very much better	13 Participants	12 Participants	19 Participants	19 Participants
PGI-I 4 years · Very much worse	2 Participants	0 Participants	3 Participants	1 Participants
PGI-I 5 years · A little better	13 Participants	16 Participants	13 Participants	11 Participants
PGI-I 5 years · A little worse	2 Participants	4 Participants	4 Participants	5 Participants
PGI-I 5 years · Much better	17 Participants	19 Participants	12 Participants	21 Participants
PGI-I 5 years · Much worse	4 Participants	0 Participants	6 Participants	2 Participants
PGI-I 5 years · No change	4 Participants	5 Participants	3 Participants	3 Participants
PGI-I 5 years · Very much better	12 Participants	11 Participants	18 Participants	15 Participants
PGI-I 5 years · Very much worse	2 Participants	0 Participants	1 Participants	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months, and 1, 2, 3, 4, and 5 years

The Pelvic Floor Impact Questionnaire measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales: the Urinary Impact Questionnaire (UIQ; 4 subscales, range 0-400), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; 4 subscales, range 0-400), and the Colorectal-Anal Impact Questionnaire (CRAIQ; 4 subscales, range 0-400). Scores are calculated by multiplying the mean value of all answered questions for a subscale by 100 divided by 3. The subscales are then added together. The range of responses is: 0-400 with 0 (least negative impact) to 400 (most negative impact). Change = (Year \[0.5, 1, 2, 3, 4, 5\] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.

Outcome measures

Outcome measures
Measure	SSLF+BPMT n=66 Participants Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training	SSLF+USUAL n=60 Participants Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training	ULS+BPMT n=62 Participants Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training	ULS+USUAL n=74 Participants Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
Change From Baseline CRAIQ Score 3 years	-54.6 units on a scale Interval -81.7 to -27.5	-20.9 units on a scale Interval -38.2 to -3.5	-12.9 units on a scale Interval -39.3 to 13.5	-36.1 units on a scale Interval -56.7 to -15.6
Change From Baseline CRAIQ Score 0.5 years	-71.3 units on a scale Interval -95.5 to -47.1	-45.5 units on a scale Interval -65.8 to -25.2	-35 units on a scale Interval -55.6 to -14.4	-66.8 units on a scale Interval -89.3 to -44.3
Change From Baseline CRAIQ Score 1 years	-73.3 units on a scale Interval -98.3 to -48.3	-43.4 units on a scale Interval -63.1 to -23.7	-37.6 units on a scale Interval -63.5 to -11.7	-60.5 units on a scale Interval -83.4 to -37.6
Change From Baseline CRAIQ Score 2 years	-47.5 units on a scale Interval -77.7 to -17.3	-25.1 units on a scale Interval -49.0 to -1.2	-19.2 units on a scale Interval -45.8 to 7.4	-38.9 units on a scale Interval -57.7 to -20.1
Change From Baseline CRAIQ Score 4 years	-40 units on a scale Interval -71.7 to -8.2	-16.6 units on a scale Interval -42.4 to 9.2	-8.5 units on a scale Interval -39.7 to 22.7	-39.1 units on a scale Interval -61.1 to -17.0
Change From Baseline CRAIQ Score 5 years	-35.7 units on a scale Interval -62.9 to -8.5	-14.8 units on a scale Interval -39.2 to 9.7	7.4 units on a scale Interval -21.8 to 36.5	-22.7 units on a scale Interval -51.0 to 5.7

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months, and 1, 2, 3, 4, and 5 years

Outcome measures

Outcome measures
Measure	SSLF+BPMT n=66 Participants Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training	SSLF+USUAL n=60 Participants Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training	ULS+BPMT n=62 Participants Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training	ULS+USUAL n=74 Participants Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
Change From Baseline POPIQ Score 2 years	-68.9 units on a scale Interval -102.5 to -35.3	-56.6 units on a scale Interval -77.9 to -35.3	-42.8 units on a scale Interval -71.1 to -14.4	-79.3 units on a scale Interval -101.4 to -57.2
Change From Baseline POPIQ Score 5 years	-72.1 units on a scale Interval -103.2 to -41.1	-50.3 units on a scale Interval -71.8 to -28.8	-16.8 units on a scale Interval -43.7 to 10.2	-71.9 units on a scale Interval -98.2 to -45.5
Change From Baseline POPIQ Score 0.5 years	-95 units on a scale Interval -123.3 to -66.7	-61.3 units on a scale Interval -85.6 to -37.0	-55.2 units on a scale Interval -79.5 to -30.9	-98.6 units on a scale Interval -122.9 to -74.4
Change From Baseline POPIQ Score 1 years	-100.2 units on a scale Interval -130.5 to -70.0	-68.8 units on a scale Interval -91.0 to -46.6	-58.9 units on a scale Interval -86.0 to -31.8	-95.9 units on a scale Interval -122.1 to -69.7
Change From Baseline POPIQ Score 3 years	-82.6 units on a scale Interval -112.0 to -53.2	-48.7 units on a scale Interval -66.6 to -30.8	-29.3 units on a scale Interval -57.3 to -1.3	-76.9 units on a scale Interval -99.2 to -54.6
Change From Baseline POPIQ Score 4 years	-84.5 units on a scale Interval -121.8 to -47.2	-42.3 units on a scale Interval -64.1 to -20.6	-32.9 units on a scale Interval -61.7 to -4.1	-73 units on a scale Interval -98.6 to -47.5

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months, and 1, 2, 3, 4, and 5 years

Outcome measures

Outcome measures
Measure	SSLF+BPMT n=66 Participants Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training	SSLF+USUAL n=60 Participants Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training	ULS+BPMT n=62 Participants Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training	ULS+USUAL n=74 Participants Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
Change From Baseline UIQ Score 2 years	-90.3 units on a scale Interval -122.8 to -57.8	-80.4 units on a scale Interval -102.1 to -58.6	-67.7 units on a scale Interval -95.7 to -39.8	-99.1 units on a scale Interval -121.4 to -76.8
Change From Baseline UIQ Score 3 years	-94.3 units on a scale Interval -120.7 to -67.9	-69.1 units on a scale Interval -87.6 to -50.7	-59 units on a scale Interval -84.0 to -34.0	-92.3 units on a scale Interval -116.4 to -68.2
Change From Baseline UIQ Score 0.5 years	-107.7 units on a scale Interval -133.9 to -81.6	-85.4 units on a scale Interval -108.7 to -62.1	-77.3 units on a scale Interval -102.1 to -52.4	-116.4 units on a scale Interval -138.6 to -94.2
Change From Baseline UIQ Score 1 years	-116.3 units on a scale Interval -143.3 to -89.3	-92 units on a scale Interval -113.0 to -71.0	-84.3 units on a scale Interval -110.2 to -58.3	-121.8 units on a scale Interval -146.2 to -97.4
Change From Baseline UIQ Score 4 years	-89.5 units on a scale Interval -124.7 to -54.3	-68.3 units on a scale Interval -89.8 to -46.7	-59.2 units on a scale Interval -87.0 to -31.3	-90.3 units on a scale Interval -117.2 to -63.4
Change From Baseline UIQ Score 5 years	-75.9 units on a scale Interval -106.0 to -45.7	-72.1 units on a scale Interval -95.2 to -49.0	-47.8 units on a scale Interval -74.0 to -21.7	-84.8 units on a scale Interval -113.0 to -56.6

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months, and 1, 2, 3, 4, and 5 years

The Pelvic Floor Distress Inventory is a validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of 3 scales: 1. Pelvic Organ Prolapse Distress Inventory (with 3 subscales), 2. Colorectal Anal Distress Inventory (with 4 subscales), and 3. Urinary Distress Inventory (with 3 subscales). Scores are calculated by multiplying the mean value of all questions answered by 25 for the subscales and then adding the subscales. The range of responses for the CRADI is: 0-400 with 0 (least distress) to 400 (most distress). Change = (Year \[0.5, 1, 2, 3, 4, 5\] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.

Outcome measures

Outcome measures
Measure	SSLF+BPMT n=70 Participants Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training	SSLF+USUAL n=64 Participants Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training	ULS+BPMT n=64 Participants Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training	ULS+USUAL n=74 Participants Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
Change From Baseline CRADI Score 0.5 years	-72.3 units on a scale Interval -88.2 to -56.4	-71.8 units on a scale Interval -88.7 to -54.8	-69.6 units on a scale Interval -87.8 to -51.4	-56.3 units on a scale Interval -73.7 to -38.9
Change From Baseline CRADI Score 1 years	-64.1 units on a scale Interval -81.0 to -47.2	-67.5 units on a scale Interval -85.6 to -49.5	-77.7 units on a scale Interval -95.7 to -59.7	-63.3 units on a scale Interval -81.3 to -45.4
Change From Baseline CRADI Score 2 years	-46.2 units on a scale Interval -68.8 to -23.6	-49.1 units on a scale Interval -70.5 to -27.6	-62 units on a scale Interval -81.3 to -42.8	-50.4 units on a scale Interval -68.9 to -31.8
Change From Baseline CRADI Score 3 years	-45.3 units on a scale Interval -68.4 to -22.2	-53.1 units on a scale Interval -73.6 to -32.6	-48.7 units on a scale Interval -69.1 to -28.3	-44.7 units on a scale Interval -63.4 to -26.1
Change From Baseline CRADI Score 4 years	-35.1 units on a scale Interval -58.0 to -12.2	-54.1 units on a scale Interval -75.8 to -32.3	-44.8 units on a scale Interval -69.6 to -19.9	-48.8 units on a scale Interval -71.2 to -26.4
Change From Baseline CRADI Score 5 years	-37.4 units on a scale Interval -61.1 to -13.7	-43.1 units on a scale Interval -61.0 to -25.2	-39.1 units on a scale Interval -60.5 to -17.6	-39.8 units on a scale Interval -58.7 to -20.9

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months, and 1, 2, 3, 4, and 5 years

The Pelvic Floor Distress Inventory is a validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of 3 scales: 1. Pelvic Organ Prolapse Distress Inventory (with 3 subscales), 2. Colorectal Anal Distress Inventory (with 4 subscales), and 3. Urinary Distress Inventory (with 3 subscales). Scores are calculated by multiplying the mean value of all questions answered by 25 for the subscales and then adding the subscales. The range of POPDI responses is: 0-300 with 0 (least distress) to 300 (most distress). Change = (Year \[0.5, 1, 2, 3, 4, 5\] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.

Outcome measures

Outcome measures
Measure	SSLF+BPMT n=70 Participants Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training	SSLF+USUAL n=64 Participants Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training	ULS+BPMT n=64 Participants Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training	ULS+USUAL n=74 Participants Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
Change From Baseline POPDI Score 0.5 years	-95.1 units on a scale Interval -108.9 to -81.4	-90.2 units on a scale Interval -106.3 to -74.1	-92.3 units on a scale Interval -110.5 to -74.1	-72.6 units on a scale Interval -88.3 to -57.0
Change From Baseline POPDI Score 1 years	-90.6 units on a scale Interval -106.0 to -75.2	-96 units on a scale Interval -112.6 to -79.5	-91.9 units on a scale Interval -110.7 to -73.1	-81.1 units on a scale Interval -93.7 to -68.4
Change From Baseline POPDI Score 2 years	-76 units on a scale Interval -94.5 to -57.5	-79.1 units on a scale Interval -97.2 to -61.1	-76.9 units on a scale Interval -96.2 to -57.7	-65.9 units on a scale Interval -80.5 to -51.2
Change From Baseline POPDI Score 3 years	-69.5 units on a scale Interval -86.2 to -52.8	-77.7 units on a scale Interval -93.9 to -61.6	-66.9 units on a scale Interval -87.3 to -46.5	-61.7 units on a scale Interval -77.6 to -45.9
Change From Baseline POPDI Score 4 years	-70.7 units on a scale Interval -87.3 to -54.1	-78.3 units on a scale Interval -97.8 to -58.8	-65.1 units on a scale Interval -88.4 to -41.9	-62.8 units on a scale Interval -79.5 to -46.1
Change From Baseline POPDI Score 5 years	-64.8 units on a scale Interval -83.7 to -45.9	-75.8 units on a scale Interval -91.9 to -59.6	-63.7 units on a scale Interval -82.3 to -45.1	-61.1 units on a scale Interval -76.6 to -45.5

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months, and 1, 2, 3, 4, and 5 years

The Pelvic Floor Distress Inventory is a validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of 3 scales: 1. Pelvic Organ Prolapse Distress Inventory (with 3 subscales), 2. Colorectal Anal Distress Inventory (with 4 subscales), and 3. Urinary Distress Inventory (with 3 subscales). Scores are calculated by multiplying the mean value of all questions answered by 25 for the subscales and then adding the subscales. The range of UDI responses is: 0-300 with 0 (least distress) to 300 (most distress). Change = (Year \[0.5, 1, 2, 3, 4, 5\] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.

Outcome measures

Outcome measures
Measure	SSLF+BPMT n=70 Participants Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training	SSLF+USUAL n=64 Participants Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training	ULS+BPMT n=64 Participants Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training	ULS+USUAL n=74 Participants Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
Change From Baseline UDI Score 1 years	-102.9 units on a scale Interval -118.4 to -87.4	-95.9 units on a scale Interval -110.9 to -80.8	-94 units on a scale Interval -110.3 to -77.7	-96.8 units on a scale Interval -111.3 to -82.3
Change From Baseline UDI Score 0.5 years	-105.7 units on a scale Interval -119.3 to -92.2	-96 units on a scale Interval -110.0 to -82.0	-95 units on a scale Interval -109.9 to -80.2	-88.9 units on a scale Interval -103.4 to -74.4
Change From Baseline UDI Score 2 years	-90.8 units on a scale Interval -109.0 to -72.6	-89.1 units on a scale Interval -104.0 to -74.2	-81.2 units on a scale Interval -98.6 to -63.9	-81.3 units on a scale Interval -95.4 to -67.2
Change From Baseline UDI Score 3 years	-84.9 units on a scale Interval -102.0 to -67.8	-75 units on a scale Interval -90.3 to -59.7	-70.5 units on a scale Interval -88.2 to -52.8	-72 units on a scale Interval -87.6 to -56.5
Change From Baseline UDI Score 4 years	-81.7 units on a scale Interval -101.9 to -61.6	-76.2 units on a scale Interval -93.2 to -59.2	-70.8 units on a scale Interval -89.5 to -52.1	-75.3 units on a scale Interval -91.2 to -59.5
Change From Baseline UDI Score 5 years	-73.9 units on a scale Interval -93.3 to -54.6	-77.9 units on a scale Interval -94.2 to -61.5	-69 units on a scale Interval -85.4 to -52.7	-74.4 units on a scale Interval -90.1 to -58.7

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months, and 1, 2, 3, 4, and 5 years

The Hunskaar Urinary Incontinence assessment measures the severity of a participant's urinary incontinence. Scores range from 1 to 8 with higher score indicating more severe incontinence. Change = (Year \[0.5, 1, 2, 3, 4, 5\] Score - Baseline Score).

Outcome measures

Outcome measures
Measure	SSLF+BPMT n=69 Participants Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training	SSLF+USUAL n=64 Participants Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training	ULS+BPMT n=64 Participants Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training	ULS+USUAL n=74 Participants Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
Change From Baseline Hunskaar Score 0.5 years	-3.6 units on a scale Interval -4.3 to -2.8	-2.9 units on a scale Interval -3.9 to -2.0	-3.2 units on a scale Interval -4.3 to -2.2	-3.5 units on a scale Interval -4.5 to -2.6
Change From Baseline Hunskaar Score 1 years	-3.6 units on a scale Interval -4.5 to -2.6	-3.3 units on a scale Interval -4.2 to -2.4	-3.4 units on a scale Interval -4.5 to -2.4	-3.2 units on a scale Interval -4.1 to -2.3
Change From Baseline Hunskaar Score 2 years	-3 units on a scale Interval -4.1 to -2.0	-3.2 units on a scale Interval -4.1 to -2.2	-2.8 units on a scale Interval -3.8 to -1.8	-2.7 units on a scale Interval -3.7 to -1.8
Change From Baseline Hunskaar Score 3 years	-2.5 units on a scale Interval -3.5 to -1.5	-2.6 units on a scale Interval -3.3 to -1.9	-2.5 units on a scale Interval -3.6 to -1.4	-2.8 units on a scale Interval -3.8 to -1.9
Change From Baseline Hunskaar Score 4 years	-2.5 units on a scale Interval -3.4 to -1.6	-2.5 units on a scale Interval -3.4 to -1.6	-2.4 units on a scale Interval -3.7 to -1.1	-2.6 units on a scale Interval -3.6 to -1.6
Change From Baseline Hunskaar Score 5 years	-1.6 units on a scale Interval -2.8 to -0.4	-2.6 units on a scale Interval -3.4 to -1.8	-2 units on a scale Interval -3.2 to -0.7	-2.4 units on a scale Interval -3.5 to -1.3

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months, and 1, 2, 3, 4, and 5 years

The health assessment questionnaire Short Form 36 Version (SF-36) determines participants' overall quality of life by assessing 1. limitations in physical functioning due to health problems; 2. limitations in usual role because of physical health problems; 3. bodily pain; 4. general health perceptions; 5. vitality; 6. limitations in social functioning because of physical or emotional problems; 7. limitations in usual role due to emotional problems; and 8. general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 "worst" - 100 "best"). Change = (Year \[0.5, 1, 2, 3, 4, 5\] Score - Baseline Score).

Outcome measures

Outcome measures
Measure	SSLF+BPMT n=72 Participants Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training	SSLF+USUAL n=62 Participants Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training	ULS+BPMT n=67 Participants Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training	ULS+USUAL n=76 Participants Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
Change From Baseline SF-36 Physical Health Score 1 years	8 units on a scale Interval 5.5 to 10.5	5.6 units on a scale Interval 2.8 to 8.3	6.6 units on a scale Interval 3.9 to 9.3	6.8 units on a scale Interval 4.2 to 9.5
Change From Baseline SF-36 Physical Health Score 3 years	4.3 units on a scale Interval 1.8 to 6.9	1.1 units on a scale Interval -1.8 to 4.0	3.5 units on a scale Interval 1.0 to 6.0	3.1 units on a scale Interval 0.5 to 5.7
Change From Baseline SF-36 Physical Health Score 5 years	3.2 units on a scale Interval 0.5 to 5.9	0.9 units on a scale Interval -2.1 to 3.8	2.5 units on a scale Interval -0.2 to 5.1	2.7 units on a scale Interval 0.2 to 5.2
Change From Baseline SF-36 Physical Health Score 0.5 years	7.1 units on a scale Interval 4.9 to 9.3	4.3 units on a scale Interval 1.4 to 7.2	5.6 units on a scale Interval 3.4 to 7.7	7.7 units on a scale Interval 5.6 to 9.7
Change From Baseline SF-36 Physical Health Score 2 years	7.6 units on a scale Interval 5.0 to 10.3	5.2 units on a scale Interval 2.6 to 7.8	4.9 units on a scale Interval 2.9 to 6.9	6.1 units on a scale Interval 4.1 to 8.1
Change From Baseline SF-36 Physical Health Score 4 years	4.8 units on a scale Interval 2.0 to 7.6	0.3 units on a scale Interval -2.9 to 3.5	2.9 units on a scale Interval 0.0 to 5.7	2.9 units on a scale Interval 0.1 to 5.6

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months, and 1, 2, 3, 4, and 5 years

Outcome measures

Outcome measures
Measure	SSLF+BPMT n=72 Participants Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training	SSLF+USUAL n=62 Participants Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training	ULS+BPMT n=67 Participants Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training	ULS+USUAL n=76 Participants Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
Change From Baseline SF-36 Mental Health Score 0.5 years	2.5 units on a scale Interval 0.0 to 5.0	3.1 units on a scale Interval 0.5 to 5.8	2.6 units on a scale Interval 0.1 to 5.2	1.3 units on a scale Interval -1.6 to 4.2
Change From Baseline SF-36 Mental Health Score 1 years	4.1 units on a scale Interval 1.5 to 6.7	3.4 units on a scale Interval 0.9 to 6.0	0.6 units on a scale Interval -2.4 to 3.6	2.7 units on a scale Interval -0.6 to 5.9
Change From Baseline SF-36 Mental Health Score 2 years	0.8 units on a scale Interval -2.0 to 3.7	2 units on a scale Interval -0.5 to 4.4	3.1 units on a scale Interval 0.7 to 5.5	1.6 units on a scale Interval -1.2 to 4.5
Change From Baseline SF-36 Mental Health Score 3 years	3 units on a scale Interval 0.0 to 6.0	2.4 units on a scale Interval -0.9 to 5.8	1.6 units on a scale Interval -1.3 to 4.5	2.3 units on a scale Interval -0.9 to 5.5
Change From Baseline SF-36 Mental Health Score 4 years	1.4 units on a scale Interval -1.2 to 4.1	1.7 units on a scale Interval -1.3 to 4.6	0.5 units on a scale Interval -2.2 to 3.1	1.2 units on a scale Interval -2.0 to 4.5
Change From Baseline SF-36 Mental Health Score 5 years	3.1 units on a scale Interval -0.3 to 6.4	1.8 units on a scale Interval -2.0 to 5.5	0.8 units on a scale Interval -1.9 to 3.4	1.2 units on a scale Interval -2.0 to 4.4

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months, and 2, 3, 4, and 5 years

The Brink scale considers three pelvic floor muscle contraction variables: vaginal pressure or muscle force, elevation or vertical displacement of the examiner fingers, and duration of contraction. The score ranges from 3 to 12 with higher scores indicating greater PFM function. Change = (Year \[0.5, 2, 3, 4, 5\] Score - Baseline Score).

Outcome measures

Outcome measures
Measure	SSLF+BPMT n=68 Participants Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training	SSLF+USUAL n=64 Participants Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training	ULS+BPMT n=68 Participants Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training	ULS+USUAL n=76 Participants Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
Change From Baseline Brink Score 0.5 years	0.2 units on a scale Interval -0.3 to 0.8	0 units on a scale Interval -0.5 to 0.5	0.6 units on a scale Interval 0.1 to 1.1	0.4 units on a scale Interval -0.1 to 0.9
Change From Baseline Brink Score 2 years	-0.1 units on a scale Interval -0.6 to 0.4	0.1 units on a scale Interval -0.5 to 0.6	0.4 units on a scale Interval 0.0 to 0.8	0 units on a scale Interval -0.4 to 0.5
Change From Baseline Brink Score 3 years	0 units on a scale Interval -0.6 to 0.6	-0.3 units on a scale Interval -1.0 to 0.4	0.3 units on a scale Interval -0.2 to 0.8	-0.5 units on a scale Interval -1.0 to 0.1
Change From Baseline Brink Score 4 years	0.1 units on a scale Interval -0.5 to 0.8	-0.5 units on a scale Interval -1.1 to 0.2	0.2 units on a scale Interval -0.3 to 0.8	-0.5 units on a scale Interval -1.1 to 0.1
Change From Baseline Brink Score 5 years	0.2 units on a scale Interval -0.5 to 0.9	-0.6 units on a scale Interval -1.3 to 0.1	0.4 units on a scale Interval -0.2 to 1.0	-0.3 units on a scale Interval -0.9 to 0.3

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months, and 1, 2, 3, 4, and 5 years

POPQ Point Ba represents the most distal (i.e. most dependent) position of any part of the upper anterior vaginal wall (between the vaginal cuff or anterior vaginal fornix and Point Aa). The range for point Ba is -3 to total vaginal length (TVL). Point Ba coincides with Point Aa (-3 cm) in a woman who has no anterior POP. In a woman with severe POP, Ba coincides with Point C. For Point Ba, better vaginal support is assigned a negative value (ie, if there is no prolapse, point Ba is -3 cm by definition). Vaginal prolapse beyond the hymen, indicating worse vaginal support, is assigned a positive value (this may be equal to the total vaginal length at the maximum).

Outcome measures

Outcome measures
Measure	SSLF+BPMT n=72 Participants Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training	SSLF+USUAL n=66 Participants Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training	ULS+BPMT n=69 Participants Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training	ULS+USUAL n=78 Participants Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
POP-Q Point Ba 0.5 years	-1.2 cm Interval -1.5 to -0.9	-1.2 cm Interval -1.5 to -0.9	-1.4 cm Interval -1.7 to -1.0	-1.3 cm Interval -1.6 to -1.0
POP-Q Point Ba 1 years	-0.9 cm Interval -1.3 to -0.5	-1.2 cm Interval -1.6 to -0.8	-1 cm Interval -1.3 to -0.7	-1.2 cm Interval -1.5 to -0.9
POP-Q Point Ba 2 years	-0.9 cm Interval -1.2 to -0.5	-0.8 cm Interval -1.1 to -0.6	-1.1 cm Interval -1.5 to -0.8	-1.1 cm Interval -1.4 to -0.8
POP-Q Point Ba 3 years	-1.1 cm Interval -1.4 to -0.7	-0.7 cm Interval -1.1 to -0.4	-0.8 cm Interval -1.2 to -0.4	-1.1 cm Interval -1.4 to -0.7
POP-Q Point Ba 4 years	-0.8 cm Interval -1.2 to -0.3	-0.9 cm Interval -1.3 to -0.6	-0.8 cm Interval -1.3 to -0.3	-1.1 cm Interval -1.5 to -0.7
POP-Q Point Ba 5 years	-0.8 cm Interval -1.2 to -0.3	-1 cm Interval -1.3 to -0.6	-0.7 cm Interval -1.2 to -0.2	-0.9 cm Interval -1.3 to -0.4

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months, and 1, 2, 3, 4, and 5 years

POP-Q Point Bp represents the most distal position of any part of the upper posterior vaginal wall (between the vaginal cuff or posterior vaginal fornix and Point Ap). It ranges from -3 to total vaginal length (TVL). Negative values indicate vaginal support above the hymen, so the more negative number the closer to normal/perfect support; positive values show prolapse beyond the hymen, so larger positive numbers are worse prolapse.

Outcome measures

Outcome measures
Measure	SSLF+BPMT n=72 Participants Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training	SSLF+USUAL n=66 Participants Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training	ULS+BPMT n=69 Participants Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training	ULS+USUAL n=78 Participants Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
POP-Q Point Bp 0.5 years	-2.3 cm Interval -2.5 to -2.0	-2.5 cm Interval -2.7 to -2.3	-2.2 cm Interval -2.5 to -2.0	-2.2 cm Interval -2.4 to -1.9
POP-Q Point Bp 1 years	-2.2 cm Interval -2.4 to -2.0	-2.4 cm Interval -2.6 to -2.2	-2.2 cm Interval -2.4 to -2.0	-2.2 cm Interval -2.5 to -2.0
POP-Q Point Bp 2 years	-2 cm Interval -2.2 to -1.7	-2.3 cm Interval -2.5 to -2.1	-2.2 cm Interval -2.4 to -2.0	-2 cm Interval -2.3 to -1.8
POP-Q Point Bp 3 years	-2.3 cm Interval -2.5 to -2.0	-2.4 cm Interval -2.6 to -2.2	-2.1 cm Interval -2.3 to -1.9	-2.2 cm Interval -2.5 to -1.9
POP-Q Point Bp 4 years	-2.2 cm Interval -2.4 to -1.9	-2.3 cm Interval -2.5 to -2.1	-2.2 cm Interval -2.4 to -1.9	-2 cm Interval -2.3 to -1.7
POP-Q Point Bp 5 years	-2.2 cm Interval -2.4 to -2.0	-2.3 cm Interval -2.5 to -2.1	-1.9 cm Interval -2.4 to -1.4	-1.9 cm Interval -2.2 to -1.6

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months, and 1 2, 3, 4, and 5 years

POP-Q Point C is measured in cm relative to the hymen with negative values being proximal to the hymen and positive values distal to the hymen. Point C represents either the most distal edge of the cervix or the leading edge of the vaginal cuff after total hysterectomy. It ranges from -TVL to +TVL. Negative values indicate vaginal support above the hymen, so the more negative number the closer to normal/perfect support; positive values show prolapse beyond the hymen, so larger positive numbers are worse prolapse.

Outcome measures

Outcome measures
Measure	SSLF+BPMT n=72 Participants Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training	SSLF+USUAL n=66 Participants Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training	ULS+BPMT n=69 Participants Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training	ULS+USUAL n=78 Participants Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
POP-Q Point C 0.5 years	-7.2 cm Interval -7.5 to -6.9	-7.3 cm Interval -7.7 to -7.0	-6.5 cm Interval -7.3 to -5.7	-7 cm Interval -7.4 to -6.7
POP-Q Point C 1 years	-7 cm Interval -7.5 to -6.5	-6.5 cm Interval -7.2 to -5.8	-6.6 cm Interval -7.0 to -6.2	-6.8 cm Interval -7.2 to -6.3
POP-Q Point C 2 years	-6.8 cm Interval -7.3 to -6.3	-6.6 cm Interval -6.9 to -6.2	-6.5 cm Interval -6.9 to -6.0	-6.8 cm Interval -7.1 to -6.5
POP-Q Point C 3 years	-6.9 cm Interval -7.2 to -6.5	-6.4 cm Interval -6.7 to -6.1	-6.3 cm Interval -6.9 to -5.8	-6.3 cm Interval -6.6 to -5.9
POP-Q Point C 4 years	-6.3 cm Interval -6.7 to -5.9	-6.2 cm Interval -6.5 to -5.8	-6.4 cm Interval -7.0 to -5.8	-6.6 cm Interval -7.0 to -6.2
POP-Q Point C 5 years	-6.5 cm Interval -7.1 to -6.0	-6.4 cm Interval -6.8 to -6.0	-5.8 cm Interval -6.5 to -5.1	-6.6 cm Interval -7.1 to -6.2

Adverse Events

SSLF+BPMT

Serious events: 0 serious events

Other events: 29 other events

Deaths: 1 deaths

SSLF+USUAL

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

ULS+BPMT

Serious events: 0 serious events

Other events: 27 other events

Deaths: 2 deaths

ULS+USUAL

Serious events: 0 serious events

Other events: 34 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	SSLF+BPMT n=72 participants at risk Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training	SSLF+USUAL n=66 participants at risk Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training	ULS+BPMT n=69 participants at risk Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training	ULS+USUAL n=78 participants at risk Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
Skin and subcutaneous tissue disorders Granulation tissue	20.8% 15/72 • 2 years through 5 years. Only specific adverse events were recorded during the extended follow-up of the OPTIMAL trial (E-OPTIMAL). Video/No video randomization arms were only assessed with regard to retention/recruitment rates and were not expected to impact outcomes or adverse events. Adverse Events were only collected with respect to the OPTIMAL treatment received.	9.1% 6/66 • 2 years through 5 years. Only specific adverse events were recorded during the extended follow-up of the OPTIMAL trial (E-OPTIMAL). Video/No video randomization arms were only assessed with regard to retention/recruitment rates and were not expected to impact outcomes or adverse events. Adverse Events were only collected with respect to the OPTIMAL treatment received.	27.5% 19/69 • 2 years through 5 years. Only specific adverse events were recorded during the extended follow-up of the OPTIMAL trial (E-OPTIMAL). Video/No video randomization arms were only assessed with regard to retention/recruitment rates and were not expected to impact outcomes or adverse events. Adverse Events were only collected with respect to the OPTIMAL treatment received.	20.5% 16/78 • 2 years through 5 years. Only specific adverse events were recorded during the extended follow-up of the OPTIMAL trial (E-OPTIMAL). Video/No video randomization arms were only assessed with regard to retention/recruitment rates and were not expected to impact outcomes or adverse events. Adverse Events were only collected with respect to the OPTIMAL treatment received.
Injury, poisoning and procedural complications Suture exposure	23.6% 17/72 • 2 years through 5 years. Only specific adverse events were recorded during the extended follow-up of the OPTIMAL trial (E-OPTIMAL). Video/No video randomization arms were only assessed with regard to retention/recruitment rates and were not expected to impact outcomes or adverse events. Adverse Events were only collected with respect to the OPTIMAL treatment received.	18.2% 12/66 • 2 years through 5 years. Only specific adverse events were recorded during the extended follow-up of the OPTIMAL trial (E-OPTIMAL). Video/No video randomization arms were only assessed with regard to retention/recruitment rates and were not expected to impact outcomes or adverse events. Adverse Events were only collected with respect to the OPTIMAL treatment received.	15.9% 11/69 • 2 years through 5 years. Only specific adverse events were recorded during the extended follow-up of the OPTIMAL trial (E-OPTIMAL). Video/No video randomization arms were only assessed with regard to retention/recruitment rates and were not expected to impact outcomes or adverse events. Adverse Events were only collected with respect to the OPTIMAL treatment received.	25.6% 20/78 • 2 years through 5 years. Only specific adverse events were recorded during the extended follow-up of the OPTIMAL trial (E-OPTIMAL). Video/No video randomization arms were only assessed with regard to retention/recruitment rates and were not expected to impact outcomes or adverse events. Adverse Events were only collected with respect to the OPTIMAL treatment received.
Injury, poisoning and procedural complications Midurethral sling erosion and exposure	4.2% 3/72 • 2 years through 5 years. Only specific adverse events were recorded during the extended follow-up of the OPTIMAL trial (E-OPTIMAL). Video/No video randomization arms were only assessed with regard to retention/recruitment rates and were not expected to impact outcomes or adverse events. Adverse Events were only collected with respect to the OPTIMAL treatment received.	1.5% 1/66 • 2 years through 5 years. Only specific adverse events were recorded during the extended follow-up of the OPTIMAL trial (E-OPTIMAL). Video/No video randomization arms were only assessed with regard to retention/recruitment rates and were not expected to impact outcomes or adverse events. Adverse Events were only collected with respect to the OPTIMAL treatment received.	2.9% 2/69 • 2 years through 5 years. Only specific adverse events were recorded during the extended follow-up of the OPTIMAL trial (E-OPTIMAL). Video/No video randomization arms were only assessed with regard to retention/recruitment rates and were not expected to impact outcomes or adverse events. Adverse Events were only collected with respect to the OPTIMAL treatment received.	0.00% 0/78 • 2 years through 5 years. Only specific adverse events were recorded during the extended follow-up of the OPTIMAL trial (E-OPTIMAL). Video/No video randomization arms were only assessed with regard to retention/recruitment rates and were not expected to impact outcomes or adverse events. Adverse Events were only collected with respect to the OPTIMAL treatment received.
Surgical and medical procedures Pelvic organ prolapse surgery	2.8% 2/72 • 2 years through 5 years. Only specific adverse events were recorded during the extended follow-up of the OPTIMAL trial (E-OPTIMAL). Video/No video randomization arms were only assessed with regard to retention/recruitment rates and were not expected to impact outcomes or adverse events. Adverse Events were only collected with respect to the OPTIMAL treatment received.	4.5% 3/66 • 2 years through 5 years. Only specific adverse events were recorded during the extended follow-up of the OPTIMAL trial (E-OPTIMAL). Video/No video randomization arms were only assessed with regard to retention/recruitment rates and were not expected to impact outcomes or adverse events. Adverse Events were only collected with respect to the OPTIMAL treatment received.	7.2% 5/69 • 2 years through 5 years. Only specific adverse events were recorded during the extended follow-up of the OPTIMAL trial (E-OPTIMAL). Video/No video randomization arms were only assessed with regard to retention/recruitment rates and were not expected to impact outcomes or adverse events. Adverse Events were only collected with respect to the OPTIMAL treatment received.	6.4% 5/78 • 2 years through 5 years. Only specific adverse events were recorded during the extended follow-up of the OPTIMAL trial (E-OPTIMAL). Video/No video randomization arms were only assessed with regard to retention/recruitment rates and were not expected to impact outcomes or adverse events. Adverse Events were only collected with respect to the OPTIMAL treatment received.

Additional Information

Marie Gantz

RTI International

Phone: 919-597-5110

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place