Apical Suspension Repair for Vault Prolapse In a Three-Arm Randomized Trial Design

Failure was defined as any of the following: retreatment for prolapse, any POP-Q measure beyond the hymen, or presence of bother on PFDI vaginal bulge question. Under the permanent failure state assumption, the number of participants shown at each visit includes all participants who were still participating in the study or had a failure outcome prior their withdrawal. Similarly, the denominator number of participants for the cumulative failure at each visit includes all participants who were still participating in the study and attended the visit or had any failure outcome prior their withdrawal or missed visit.

Time frame: 6 months through 60 Months

Population: An modified intent-to-treat (ITT) analysis which included all eligible participants who were randomized, received the randomized procedure, and who provided outcome data after baseline was performed.

The Body Part Pain Scale measuring the pain experienced in the lower abdomen and pelvic region of the body is composed of 7 questions, each with a yes (1) or no (0) questions about experiencing pain followed by an intensity rating: 0 (No pain),..., 10 (Most intense). The score is calculated as the average of the responses. The range of responses is: 0-10 with 0 (No pain) to 10 (most intense pain). Lower scores indicate better function / fewer symptoms. Change = (Month \[6, 12, 18, 24, and 36\] Score - Baseline Score).

Time frame: 6 months through 60 Months

Population: An modified intent-to-treat (ITT) analysis which included all eligible participants who were randomized, received the randomized procedure, and who provided outcome data after baseline was performed.

The Pelvic Floor Distress Inventory is a 20-question, validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of an overall scale (range: 0-300) comprised of 3 sub-scales: 1. Pelvic Organ Prolapse Distress Inventory (range: 0-100), 2. Colorectal Anal Distress Inventory (range: 0-100), and 3. Urinary Distress Inventory (range: 0-100). The range of responses for all questions is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit. Subscale scores are calculated by multiplying the mean value of all questions answered by 25 for the subscale. The range of score for each subscale is: 0-100 with 0 (least distress) to 100 (most distress). The PFDI is calculated as the sum of the three subscales. Lower scores indicate better function / fewer symptoms for the PFDI scale, POPDI subscale, CRADI subscale, and UDI subscale. Change from baseline = (Month \[12, 24, 36\] Score - Baseline Score).

Time frame: 6 months through 60 Months

Population: An modified intent-to-treat (ITT) analysis which included all eligible participants who were randomized, received the randomized procedure, and who provided outcome data after baseline was performed.

The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of an overall score (range 0-300), 3 subscales (7 questions each): the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). The range of responses on all questions is 0-3 with (0) Not at all ... (3), Quite a bit. Subscale scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of scores for each subscale is: 0-100 with 0 (least negative impact) to 100 (most negative impact). The PFIQ is the sum of the three subscales. Lower scores indicate better function / fewer symptoms for the PFIQ score, UIQ score, POPIQ score, and CRAIQ score. Change = (Week \[12, 24\] Score - Baseline Score).

Time frame: 6 months through 60 Months

Population: An modified intent-to-treat (ITT) analysis which included all eligible participants who were randomized, received the randomized procedure, and who provided outcome data after baseline was performed.

Functional Activity Scale measuring the impact of incontinence symptoms on a woman's daily activities is composed of 13 questions about normal and physically strenuous daily activities. The range of responses on the individual questions is (1) No difficulty,... (5) Not able to do it. Scores are calculated by subtracting from the maximum sum (5\*13=65) the product of the mean response and number of questions, then dividing by the total range of sums (65 - 13 = 52) and multiplying by 100. The range of responses is: 0-100 with 0 (worse functionality) to 100 (Better functionality). Change = (Month \[6, 12, 18, 24, and 36\] Score - Baseline Score).

Time frame: 6 months through 60 Months

Population: An modified intent-to-treat (ITT) analysis which included all eligible participants who were randomized, received the randomized procedure, and who provided outcome data after baseline was performed.

The Pelvic Floor Distress Inventory is a 20-question, validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of an overall scale (range: 0-300) comprised of 3 sub-scales: 1. Pelvic Organ Prolapse Distress Inventory (range: 0-100), 2. Colorectal Anal Distress Inventory (range: 0-100), and 3. Urinary Distress Inventory (range: 0-100). The range of responses for all questions is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit. Subscale scores are calculated by multiplying the mean value of all questions answered by 25 for the subscale. The range of score for each subscale is: 0-100 with 0 (least distress) to 100 (most distress). The PFDI is calculated as the sum of the three subscales. Lower scores indicate better function / fewer symptoms for the PFDI scale, POPDI subscale, CRADI subscale, and UDI subscale. Change from baseline = (Month \[12, 24, 36\] Score - Baseline Score).

Time frame: 6 months through 60 Months

Population: An modified intent-to-treat (ITT) analysis which included all eligible participants who were randomized, received the randomized procedure, and who provided outcome data after baseline was performed.

The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of an overall score (range 0-300), 3 subscales (7 questions each): the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). The range of responses on all questions is 0-3 with (0) Not at all ... (3), Quite a bit. Subscale scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of scores for each subscale is: 0-100 with 0 (least negative impact) to 100 (most negative impact). The PFIQ is the sum of the three subscales. Lower scores indicate better function / fewer symptoms for the PFIQ score, UIQ score, POPIQ score, and CRAIQ score. Change = (Week \[12, 24\] Score - Baseline Score).

Time frame: 6 months through 60 Months

Population: An modified intent-to-treat (ITT) analysis which included all eligible participants who were randomized, received the randomized procedure, and who provided outcome data after baseline was performed.

The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR) is a questionnaire measuring the impact of incontinence symptoms on sexual function and satisfaction. The PISQ-IR Sexually Active-Average Score (SA-AVG) ranges from 0 to 5 with higher scores indicating better function/satisfaction. The change from baseline outcome is calculated as the difference in score at 6, 12, 18, 24, and 36 months and the score at baseline.

Time frame: 6 months through 60 Months

Population: An modified intent-to-treat (ITT) analysis which included all eligible participants who were randomized, received the randomized procedure, and who provided outcome data after baseline was performed.

The Pelvic Floor Distress Inventory is a 20-question, validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of an overall scale (range: 0-300) comprised of 3 sub-scales: 1. Pelvic Organ Prolapse Distress Inventory (range: 0-100), 2. Colorectal Anal Distress Inventory (range: 0-100), and 3. Urinary Distress Inventory (range: 0-100). The range of responses for all questions is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit. Subscale scores are calculated by multiplying the mean value of all questions answered by 25 for the subscale. The range of score for each subscale is: 0-100 with 0 (least distress) to 100 (most distress). The PFDI is calculated as the sum of the three subscales. Lower scores indicate better function / fewer symptoms for the PFDI scale, POPDI subscale, CRADI subscale, and UDI subscale. Change from baseline = (Month \[12, 24, 36\] Score - Baseline Score).

Time frame: 6 months through 60 Months

Population: An modified intent-to-treat (ITT) analysis which included all eligible participants who were randomized, received the randomized procedure, and who provided outcome data after baseline was performed.

The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of an overall score (range 0-300), 3 subscales (7 questions each): the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). The range of responses on all questions is 0-3 with (0) Not at all ... (3), Quite a bit. Subscale scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of scores for each subscale is: 0-100 with 0 (least negative impact) to 100 (most negative impact). The PFIQ is the sum of the three subscales. Lower scores indicate better function / fewer symptoms for the PFIQ score, UIQ score, POPIQ score, and CRAIQ score. Change = (Week \[12, 24\] Score - Baseline Score).

Time frame: 6 months through 60 Months

Population: An modified intent-to-treat (ITT) analysis which included all eligible participants who were randomized, received the randomized procedure, and who provided outcome data after baseline was performed.

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). 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.

Time frame: 6 months through 60 Months

Population: An modified intent-to-treat (ITT) analysis which included all eligible participants who were randomized, received the randomized procedure, and who provided outcome data after baseline was performed.

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).

Time frame: 6 months through 60 Months

Population: An modified intent-to-treat (ITT) analysis which included all eligible participants who were randomized, received the randomized procedure, and who provided outcome data after baseline was performed.

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.

Time frame: 6 months through 60 Months

Population: An modified intent-to-treat (ITT) analysis which included all eligible participants who were randomized, received the randomized procedure, and who provided outcome data after baseline was performed.

POP-Q Total Vaginal Length (TVL) is measured in cm. It is the length of the vagina from posterior fornix to the hymen when Point C or D is reduced to its full normal position.

Time frame: 6 months through 60 Months

Population: An modified intent-to-treat (ITT) analysis which included all eligible participants who were randomized, received the randomized procedure, and who provided outcome data after baseline was performed.

The Surgical Pain Scale measuring the post-surgical pain experienced by a subject is composed of 4 questions: Pain at Rest (range 0-10), Pain with Normal Activities (range 0-10), Pain with Exercise (range 0-10), and Intensity of Worst Pain (range 0-10). Lower scores indicate better less pain for the Rest subscale, Normal subscale, Exercise Subscale, and Worst Subscale. Change = (Month \[6, 12, 18, 24, and 36\] Score - Baseline Score).

Time frame: 6 months through 60 Months

Population: An modified intent-to-treat (ITT) analysis which included all eligible participants who were randomized, received the randomized procedure, and who provided outcome data after baseline was performed.

The Surgical Pain Scale measuring the post-surgical pain experienced by a subject is composed of 4 questions: Pain at Rest (range 0-10), Pain with Normal Activities (range 0-10), Pain with Exercise (range 0-10), and Intensity of Worst Pain (range 0-10). Lower scores indicate better less pain for the Rest subscale, Normal subscale, Exercise Subscale, and Worst Subscale. Change = (Month \[6, 12, 18, 24, and 36\] Score - Baseline Score).

Time frame: 6 months through 60 Months

Population: An modified intent-to-treat (ITT) analysis which included all eligible participants who were randomized, received the randomized procedure, and who provided outcome data after baseline was performed.

The Surgical Pain Scale measuring the post-surgical pain experienced by a subject is composed of 4 questions: Pain at Rest (range 0-10), Pain with Normal Activities (range 0-10), Pain with Exercise (range 0-10), and Intensity of Worst Pain (range 0-10). Lower scores indicate better less pain for the Rest subscale, Normal subscale, Exercise Subscale, and Worst Subscale. Change = (Month \[6, 12, 18, 24, and 36\] Score - Baseline Score).

Time frame: 6 months through 60 Months

Population: An modified intent-to-treat (ITT) analysis which included all eligible participants who were randomized, received the randomized procedure, and who provided outcome data after baseline was performed.

The Surgical Pain Scale measuring the post-surgical pain experienced by a subject is composed of 4 questions: Pain at Rest (range 0-10), Pain with Normal Activities (range 0-10), Pain with Exercise (range 0-10), and Intensity of Worst Pain (range 0-10). Lower scores indicate better less pain for the Rest subscale, Normal subscale, Exercise Subscale, and Worst Subscale. Change = (Month \[6, 12, 18, 24, and 36\] Score - Baseline Score).

Time frame: 6 months through 60 Months

Population: An modified intent-to-treat (ITT) analysis which included all eligible participants who were randomized, received the randomized procedure, and who provided outcome data after baseline was performed.

The Pelvic Floor Distress Inventory is a 20-question, validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of an overall scale (range: 0-300) comprised of 3 sub-scales: 1. Pelvic Organ Prolapse Distress Inventory (range: 0-100), 2. Colorectal Anal Distress Inventory (range: 0-100), and 3. Urinary Distress Inventory (range: 0-100). The range of responses for all questions is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit. Subscale scores are calculated by multiplying the mean value of all questions answered by 25 for the subscale. The range of score for each subscale is: 0-100 with 0 (least distress) to 100 (most distress). The PFDI is calculated as the sum of the three subscales. Lower scores indicate better function / fewer symptoms for the PFDI scale, POPDI subscale, CRADI subscale, and UDI subscale. Change from baseline = (Month \[12, 24, 36\] Score - Baseline Score).

Time frame: 6 months through 60 Months

Population: An modified intent-to-treat (ITT) analysis which included all eligible participants who were randomized, received the randomized procedure, and who provided outcome data after baseline was performed.

The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of an overall score (range 0-300), 3 subscales (7 questions each): the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). The range of responses on all questions is 0-3 with (0) Not at all ... (3), Quite a bit. Subscale scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of scores for each subscale is: 0-100 with 0 (least negative impact) to 100 (most negative impact). The PFIQ is the sum of the three subscales. Lower scores indicate better function / fewer symptoms for the PFIQ score, UIQ score, POPIQ score, and CRAIQ score. Change = (Week \[12, 24\] Score - Baseline Score).

Time frame: 6 months through 60 Months

Population: An modified intent-to-treat (ITT) analysis which included all eligible participants who were randomized, received the randomized procedure, and who provided outcome data after baseline was performed.

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). Included here are participants who had improvement as indicated by a rating of 1 (very much better), 2 (much better).

Time frame: 6 months through 60 Months

Population: An modified intent-to-treat (ITT) analysis which included all eligible participants who were randomized, received the randomized procedure, and who provided outcome data after baseline was performed.