Measured via palpability scale with possible outcomes of none, mild, moderate, or severe.

All subjects

Percentage of de novo dyspareunia measured via validated Participant Sexual Function Questionnaire-12 (PISQ-12) questionnaire at 6 weeks. The specific PISQ-12 score was based upon Question 3.5, "Do you feel pain during sexual intercourse?" The subjects' response was counted as having de novo dyspareunia if the response was "sometimes" "usually" or "always."

The 12 sexually active subjects without dyspareunia at baseline.

Percentage of de novo dyspareunia measured via validated Participant Sexual Function Questionnaire-12 (PISQ-12) questionnaire at 3 months. The specific PISQ-12 score was based upon Question 3.5, "Do you feel pain during sexual intercourse?" The subjects' response was counted as having de novo dyspareunia if the response was "sometimes" "usually" or "always."

The 12 sexually active subjects without dyspareunia at baseline.

Percentage of de novo dyspareunia measured via validated Participant Sexual Function Questionnaire-12 (PISQ-12) questionnaire at six months. The specific PISQ-12 score was based upon Question 3.5, "Do you feel pain during sexual intercourse?" The subjects' response was counted as having de novo dyspareunia if the response was "sometimes" "usually" or "always."

The 12 sexually active subjects without dyspareunia at baseline.

Percentage of de novo dyspareunia measured via validated Participant Sexual Function Questionnaire-12 (PISQ-12) questionnaire at 12 months. The specific PISQ-12 score was based upon Question 3.5, "Do you feel pain during sexual intercourse?" The subjects' response was counted as having de novo dyspareunia if the response was "sometimes" "usually" or "always."

The 11 sexually active subjects without dyspareunia at baseline. At the 12 month follow-up visit, only 11 subjects were sexually active and thus only 11 subjects completed Question 3.5 on the PISQ-12 questionnaire. Therefore, the number of participants analyzed for this outcome was 11 at the 12 month follow-up visit.

Surgical success rates of the anterior compartments after vaginal reconstruction surgery via Pelvic Organ Prolapse Quantification system (POP-Q) at 6 weeks. Surgical success rate is defined as the post-operative point of maximal prolapse being less than 0 cm (i.e. above the hymenal ring).

The 27 subjects who were treated with Restorelle Direct Fix in the anterior compartment.

Percentage of participants with surgical success rates of the anterior compartments after vaginal reconstruction surgery via Pelvic Organ Prolapse Quantification system (POP-Q) at 3 months. Surgical success rate is defined as the post-operative point of maximal prolapse being less than 0 cm (i.e. above the hymenal ring).

The 27 subjects who were treated with Restorelle Direct Fix in the anterior compartment.

Percentage of participants with surgical success rates of the anterior compartments after vaginal reconstruction surgery via Pelvic Organ Prolapse Quantification system (POP-Q) at 6 months. Surgical success rate is defined as the post-operative point of maximal prolapse being less than 0 cm (i.e. above the hymenal ring).

The 27 subjects who were treated with Restorelle Direct Fix in the anterior compartment.

Percentage of participants with surgical success rates of the anterior compartments after vaginal reconstruction surgery via Pelvic Organ Prolapse Quantification system (POP-Q) at 12 months. Surgical success rate is defined as the post-operative point of maximal prolapse being less than 0 cm (i.e. above the hymenal ring).

The 27 subjects who were treated with Restorelle Direct Fix in the anterior compartment.

Measured via palpability scale with possible outcomes of none, mild, moderate, or severe.

All subjects

Measured via palpability scale with possible outcomes of none, mild, moderate, or severe.

All study subjects

Measured via palpability scale with possible outcomes of none, mild, moderate, or severe.

All subjects

Measured via palpability scale with possible outcomes of none, mild, moderate, or severe.

All subjects

Percentage of participants with anterior and posterior compartment mesh exposure/extrusion after vaginal reconstruction with Restorelle Direct Fix at 12 months. Per the protocol, mesh extrusion is defined as "passage gradually out of a body structure or tissue." Mesh exposure is defined as " a condition of displaying, revealing, exhibiting or making accessible e.g. vaginal mesh visualized through separated vaginal epithelium."

All study subjects.

Percentage of participants with surgical success of the posterior compartment after vaginal reconstruction surgery via Pelvic Organ Prolapse Quantification system (POP-Q) at the 6 week visit. Surgical success is defined as the post-operative point of maximal prolapse being less than 0 cm (i.e. above the hymenal ring).

The 6 subjects who were treated in the posterior compartment with Restorelle Direct Fix.

Percentage of participants with surgical success of the posterior compartment after vaginal reconstruction surgery via Pelvic Organ Prolapse Quantification system (POP-Q) at the 3 month visit. Surgical success is defined as the post-operative point of maximal prolapse being less than 0 cm (i.e. above the hymenal ring).

The six subjects who had posterior compartment vaginal reconstruction surgery.

Percentage of participants with surgical success of the posterior compartment after vaginal reconstruction surgery via Pelvic Organ Prolapse Quantification system (POP-Q) at the 6 month visit Surgical success is defined as the post-operative point of maximal prolapse being less than 0 cm (i.e. above the hymenal ring).

The 5 subjects who were treated in the posterior compartment with Restorelle Direct Fix and have POP-Q measurement recorded at the six month follow-up visit.

Percentage of participants with surgical success of the posterior compartment after vaginal reconstruction surgery via Pelvic Organ Prolapse Quantification system (POP-Q) at the 12 month visit. Surgical success is defined as the post-operative point of maximal prolapse being less than 0 cm (i.e. above the hymenal ring).

The 6 subjects who were treated in the posterior compartment with Restorelle Direct Fix.

The PGI-I Index consists on one question and was collected at 6 weeks. The question is "Check the box that best describes how your condition is now, compared with how it was before you had the operation." There are seven possible responses including "very much better," "much better," "a little better," "no change," "a little worse," "much worse" and "very much worse" and the subject chooses one response.

The 29 subjects who completed the PGI-I at the six week follow up visit.

The PGI-I Index consists on one question and was collected at 3 months. The question is "Check the box that best describes how your condition is now, compared with how it was before you had the operation. There are seven possible responses including "very much better," "much better," "a little better," "no change," "a little worse," "much worse" and "very much worse" and the subject chooses one response.

The 29 subjects who completed the PGI-I at the three month follow up visit.

The PGI-I Index consists on one question and was collected at 6 months. The question is "Check the box that best describes how your condition is now, compared with how it was before you had the operation. There are seven possible responses including "very much better," "much better," "a little better," "no change," "a little worse," "much worse" and "very much worse" and the subject chooses one response.

The 29 subjects who completed the PGI-I at the six month follow up visit.

The PGI-I Index consists on one question and was collected at 12 months. The question is "Check the box that best describes how your condition is now, compared with how it was before you had the operation. There are seven possible responses including "very much better," "much better," "a little better," "no change," "a little worse," "much worse" and "very much worse" and the subject chooses one response.

All subjects

Bladder function is measured by UDI-6 Questionnaire at 6 weeks. The UDI-6 measures bladder function. The range of responses is: 1-4 with (1) not at all, (2) somewhat, (3) moderately, and (4 quite a bit). To allow for missing responses, the average score of items responded to, rather than the total, is taken. The average, which ranges from 1 to 4, is multiplied by 25 to put scores on a scale of 0 to 100. Higher scores indicate worse symptoms.

All subjects.

Bladder function is measured by UDI-6 Questionnaire at 3 months. The UDI-6 measures bladder function. The range of responses is: 1-4 with (1) not at all, (2) somewhat, (3) moderately, and (4 quite a bit). To allow for missing responses, the average score of items responded to, rather than the total, is taken. The average, which ranges from 1 to 4, is multiplied by 25 to put scores on a scale of 0 to 100. Higher scores indicate worse symptoms.

All subjects.

Bladder function is measured by UDI-6 Questionnaire at 6 months. The UDI-6 measures bladder function. The range of responses is: 1-4 with (1) not at all, (2) somewhat, (3) moderately, and (4 quite a bit). To allow for missing responses, the average score of items responded to, rather than the total, is taken. The average, which ranges from 1 to 4, is multiplied by 25 to put scores on a scale of 0 to 100. Higher scores indicate worse symptoms.

All subjects.

Bladder function is measured by UDI-6 Questionnaire at 12 months. The UDI-6 measures bladder function. The range of responses is: 1-4 with (1) not at all, (2) somewhat, (3) moderately, and (4 quite a bit). To allow for missing responses, the average score of items responded to, rather than the total, is taken. The average, which ranges from 1 to 4, is multiplied by 25 to put scores on a scale of 0 to 100. Higher scores indicate worse symptoms.

All subjects.

Sexual function in women with pelvic organ prolapse is measured by the PISQ-12 at 6 weeks. The scores range from 0-48 with lower scores indicating better sexual function. Scores are calculated by totalling the scores for each question with (4) always, (3) usually, (2) sometimes, (1) seldom, and (0) never. Reverse scoring is used for items 1, 2, 3 and 4. The short form questionnaire can be used with up to two missing responses. To handle missing values, the sum is calculated by multiplying the number of items by the mean of the answered items.

The 28 subjects who completed the PISQ-12 at the six week follow up visit.

Sexual function in women with pelvic organ prolapse is measured by the PISQ-12 at 3 months. The scores range from 0-48 with lower scores indicating better sexual function. Scores are calculated by totalling the scores for each question with (4) always, (3) usually, (2) sometimes, (1) seldom, and (0) never. Reverse scoring is used for items 1, 2, 3 and 4. The short form questionnaire can be used with up to two missing responses. To handle missing values, the sum is calculated by multiplying the number of items by the mean of the answered items.

The 25 subjects who completed the PISQ-12 at the three month follow up visit.

Sexual function in women with pelvic organ prolapse is measured by the PISQ-12 at 6 months. The scores range from 0-48 with lower scores indicating better sexual function. Scores are calculated by totalling the scores for each question with (4) always, (3) usually, (2) sometimes, (1) seldom, and (0) never. Reverse scoring is used for items 1, 2, 3 and 4. The short form questionnaire can be used with up to two missing responses. To handle missing values, the sum is calculated by multiplying the number of items by the mean of the answered items.

The 26 subjects who completed the PISQ-12 at the six month follow up visit.

Sexual function in women with pelvic organ prolapse is measured by the PISQ-12 at12 months. The scores range from 0-48 with lower scores indicating better sexual function. Scores are calculated by totalling the scores for each question with (4) always, (3) usually, (2) sometimes, (1) seldom, and (0) never. Reverse scoring is used for items 1, 2, 3 and 4. The short form questionnaire can be used with up to two missing responses. To handle missing values, the sum is calculated by multiplying the number of items by the mean of the answered items.

The 25 subjects who completed the PISQ-12 at the twelve month follow up visit.

Colorectal-anal Distress Inventory is measured by the CRADI-8 at 6 weeks. The range of responses is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit. Scores are calculated by multiplying the mean value of all questions answered by 25. The range of responses is: 0-100 with 0 (least distress) to 100 (most distress).

All subjects

Colorectal-anal Distress Inventory is measured by the CRADI-8 at 3 months. The range of responses is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit. Scores are calculated by multiplying the mean value of all questions answered by 25. The range of responses is: 0-100 with 0 (least distress) to 100 (most distress).

All subjects

Colorectal-anal Distress Inventory is measured by the CRADI-8 at 6 months. The range of responses is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit. Scores are calculated by multiplying the mean value of all questions answered by 25. The range of responses is: 0-100 with 0 (least distress) to 100 (most distress).

All subjects

Colorectal-anal Distress Inventory is measured by the CRADI-8 at 12 months. The range of responses is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit. Scores are calculated by multiplying the mean value of all questions answered by 25. The range of responses is: 0-100 with 0 (least distress) to 100 (most distress).

All subjects