Trial Outcomes & Findings for Restorelle Direct Fix Anterior and Posterior (A&P) for Female Pelvic Organ Prolapse: A Prospective Post Market Study (NCT NCT01378065)

NCT ID: NCT01378065

Last Updated: 2020-05-12

Results Overview

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

• Recruitment status: COMPLETED
• Target enrollment: 31 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2020-05-12

Participant Flow

Participant milestones

Measure	Restorelle Direct Fix Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A \& P in the anterior and/or posterior compartment.
Overall Study STARTED	30
Overall Study 6 Week	30
Overall Study 3 Months	30
Overall Study 6 Months	30
Overall Study 12 Months	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Restorelle Direct Fix Anterior and Posterior (A&P) for Female Pelvic Organ Prolapse: A Prospective Post Market Study

Baseline characteristics by cohort

Measure	Restorelle Direct Fix n=30 Participants Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A \& P in the anterior and/or posterior compartment.
Age, Continuous	62.1 years STANDARD_DEVIATION 12.8 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants
Body Mass Index (BMI)	27.9 Kg/m^2 STANDARD_DEVIATION 5.6 • n=5 Participants
Weight	164.7 pound STANDARD_DEVIATION 36.8 • n=5 Participants
Height	64.3 Inches STANDARD_DEVIATION 2.9 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Population: All subjects

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

Outcome measures

Measure	Restorelle Direct Fix n=30 Participants Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A \& P in the anterior and/or posterior compartment.
Palpability of the Restorelle Direct Fix Anterior and Posterior (A&P) Posterior - 4 cm from introitus at midline:Severe	0 participants
Palpability of the Restorelle Direct Fix Anterior and Posterior (A&P) Anterior - inside hymenal ring: None	30 participants
Palpability of the Restorelle Direct Fix Anterior and Posterior (A&P) Anterior - inside hymenal ring: Mild	0 participants
Palpability of the Restorelle Direct Fix Anterior and Posterior (A&P) Anterior - inside hymenal ring: Moderate	0 participants
Palpability of the Restorelle Direct Fix Anterior and Posterior (A&P) Anterior - inside hymenal ring: Severe	0 participants
Palpability of the Restorelle Direct Fix Anterior and Posterior (A&P) Anterior - 4 cm from introitus at midline: None	30 participants
Palpability of the Restorelle Direct Fix Anterior and Posterior (A&P) Anterior - 4 cm from introitus at midline: Mild	0 participants
Palpability of the Restorelle Direct Fix Anterior and Posterior (A&P) Anterior - 4 cm from introitus at midline: Moderat	0 participants
Palpability of the Restorelle Direct Fix Anterior and Posterior (A&P) Anterior - 4 cm from introitus at midline: Severe	0 participants
Palpability of the Restorelle Direct Fix Anterior and Posterior (A&P) Anterior - apex: None	30 participants
Palpability of the Restorelle Direct Fix Anterior and Posterior (A&P) Anterior - apex: Mild	0 participants
Palpability of the Restorelle Direct Fix Anterior and Posterior (A&P) Anterior - apex: Moderate	0 participants
Palpability of the Restorelle Direct Fix Anterior and Posterior (A&P) Anterior - apex: Severe	0 participants
Palpability of the Restorelle Direct Fix Anterior and Posterior (A&P) Posterior - inside hymenal ring: None	30 participants
Palpability of the Restorelle Direct Fix Anterior and Posterior (A&P) Posterior - inside hymenal ring: Mild	0 participants
Palpability of the Restorelle Direct Fix Anterior and Posterior (A&P) Posterior - inside hymenal ring: Moderate	0 participants
Palpability of the Restorelle Direct Fix Anterior and Posterior (A&P) Posterior - inside hymenal ring: Severe	0 participants
Palpability of the Restorelle Direct Fix Anterior and Posterior (A&P) Posterior - 4 cm from introitus at midline: None	29 participants
Palpability of the Restorelle Direct Fix Anterior and Posterior (A&P) Posterior - 4 cm from introitus at midline: Mild	1 participants
Palpability of the Restorelle Direct Fix Anterior and Posterior (A&P) Posterior - 4 cm from introitus at midline: Modera	0 participants
Palpability of the Restorelle Direct Fix Anterior and Posterior (A&P) Posterior - apex: None	29 participants
Palpability of the Restorelle Direct Fix Anterior and Posterior (A&P) Posterior - apex: Mild	1 participants
Palpability of the Restorelle Direct Fix Anterior and Posterior (A&P) Posterior - apex: Moderate	0 participants
Palpability of the Restorelle Direct Fix Anterior and Posterior (A&P) Posterior - apex: Severe	0 participants

PRIMARY outcome

Timeframe: 6 weeks

Population: All subjects

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

Outcome measures

Measure	Restorelle Direct Fix n=30 Participants Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A \& P in the anterior and/or posterior compartment.
Palpability of the Restorelle Direct Fix A&P Anterior - inside hymenal ring: None	29 participants
Palpability of the Restorelle Direct Fix A&P Anterior - inside hymenal ring: Mild	1 participants
Palpability of the Restorelle Direct Fix A&P Anterior - inside hymenal ring: Moderate	0 participants
Palpability of the Restorelle Direct Fix A&P Anterior - inside hymenal ring: Severe	0 participants
Palpability of the Restorelle Direct Fix A&P Anterior - 4 cm from introitus at midline: None	27 participants
Palpability of the Restorelle Direct Fix A&P Anterior - 4 cm from introitus at midline: Mild	3 participants
Palpability of the Restorelle Direct Fix A&P Anterior - 4 cm from introitus at midline: Moderat	0 participants
Palpability of the Restorelle Direct Fix A&P Anterior - 4 cm from introitus at midline: Severe	0 participants
Palpability of the Restorelle Direct Fix A&P Anterior - apex: None	26 participants
Palpability of the Restorelle Direct Fix A&P Anterior - apex: Mild	4 participants
Palpability of the Restorelle Direct Fix A&P Anterior - apex: Moderate	0 participants
Palpability of the Restorelle Direct Fix A&P Anterior - apex: Severe	0 participants
Palpability of the Restorelle Direct Fix A&P Posterior - inside hymenal ring: None	30 participants
Palpability of the Restorelle Direct Fix A&P Posterior - inside hymenal ring: Mild	0 participants
Palpability of the Restorelle Direct Fix A&P Posterior - inside hymenal ring: Moderate	0 participants
Palpability of the Restorelle Direct Fix A&P Posterior - inside hymenal ring: Severe	0 participants
Palpability of the Restorelle Direct Fix A&P Posterior - 4 cm from introitus at midline: None	27 participants
Palpability of the Restorelle Direct Fix A&P Posterior - 4 cm from introitus at midline: Mild	2 participants
Palpability of the Restorelle Direct Fix A&P Posterior - 4 cm from introitus at midline: Modera	1 participants
Palpability of the Restorelle Direct Fix A&P Posterior - 4 cm from introitus at midline:Severe	0 participants
Palpability of the Restorelle Direct Fix A&P Posterior - apex: None	27 participants
Palpability of the Restorelle Direct Fix A&P Posterior - apex: Mild	2 participants
Palpability of the Restorelle Direct Fix A&P Posterior - apex: Moderate	1 participants
Palpability of the Restorelle Direct Fix A&P Posterior - apex: Severe	0 participants

PRIMARY outcome

Timeframe: 3 months

Population: All study subjects

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

Outcome measures

Measure	Restorelle Direct Fix n=30 Participants Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A \& P in the anterior and/or posterior compartment.
Palpability of the Restorelle Direct Fix A&P Anterior - inside hymenal ring: None	29 participants
Palpability of the Restorelle Direct Fix A&P Anterior - inside hymenal ring: Mild	1 participants
Palpability of the Restorelle Direct Fix A&P Anterior - inside hymenal ring: Moderate	0 participants
Palpability of the Restorelle Direct Fix A&P Anterior - inside hymenal ring: Severe	0 participants
Palpability of the Restorelle Direct Fix A&P Anterior - 4 cm from introitus at midline: None	26 participants
Palpability of the Restorelle Direct Fix A&P Anterior - 4 cm from introitus at midline: Mild	4 participants
Palpability of the Restorelle Direct Fix A&P Anterior - 4 cm from introitus at midline: Moderat	0 participants
Palpability of the Restorelle Direct Fix A&P Anterior - 4 cm from introitus at midline: Severe	0 participants
Palpability of the Restorelle Direct Fix A&P Anterior - apex: None	26 participants
Palpability of the Restorelle Direct Fix A&P Anterior - apex: Mild	4 participants
Palpability of the Restorelle Direct Fix A&P Anterior - apex: Moderate	0 participants
Palpability of the Restorelle Direct Fix A&P Anterior - apex: Severe	0 participants
Palpability of the Restorelle Direct Fix A&P Posterior - inside hymenal ring: None	28 participants
Palpability of the Restorelle Direct Fix A&P Posterior - inside hymenal ring: Mild	2 participants
Palpability of the Restorelle Direct Fix A&P Posterior - inside hymenal ring: Moderate	0 participants
Palpability of the Restorelle Direct Fix A&P Posterior - inside hymenal ring: Severe	0 participants
Palpability of the Restorelle Direct Fix A&P Posterior - 4 cm from introitus at midline: None	28 participants
Palpability of the Restorelle Direct Fix A&P Posterior - 4 cm from introitus at midline: Mild	2 participants
Palpability of the Restorelle Direct Fix A&P Posterior - 4 cm from introitus at midline: Modera	0 participants
Palpability of the Restorelle Direct Fix A&P Posterior - 4 cm from introitus at midline:Severe	0 participants
Palpability of the Restorelle Direct Fix A&P Posterior - apex: None	28 participants
Palpability of the Restorelle Direct Fix A&P Posterior - apex: Mild	2 participants
Palpability of the Restorelle Direct Fix A&P Posterior - apex: Moderate	0 participants
Palpability of the Restorelle Direct Fix A&P Posterior - apex: Severe	0 participants

PRIMARY outcome

Timeframe: 6 months

Population: All subjects

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

Outcome measures

Measure	Restorelle Direct Fix n=30 Participants Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A \& P in the anterior and/or posterior compartment.
Palpability of the Restorelle Direct Fix A&P Anterior - apex: Mild	2 participants
Palpability of the Restorelle Direct Fix A&P Anterior - apex: Moderate	3 participants
Palpability of the Restorelle Direct Fix A&P Anterior - apex: Severe	0 participants
Palpability of the Restorelle Direct Fix A&P Posterior - inside hymenal ring: None	28 participants
Palpability of the Restorelle Direct Fix A&P Posterior - inside hymenal ring: Mild	1 participants
Palpability of the Restorelle Direct Fix A&P Posterior - inside hymenal ring: Moderate	1 participants
Palpability of the Restorelle Direct Fix A&P Posterior - inside hymenal ring: Severe	0 participants
Palpability of the Restorelle Direct Fix A&P Posterior - 4 cm from introitus at midline: None	26 participants
Palpability of the Restorelle Direct Fix A&P Posterior - 4 cm from introitus at midline: Mild	3 participants
Palpability of the Restorelle Direct Fix A&P Posterior - 4 cm from introitus at midline: Modera	1 participants
Palpability of the Restorelle Direct Fix A&P Posterior - 4 cm from introitus at midline:Severe	0 participants
Palpability of the Restorelle Direct Fix A&P Posterior - apex: None	27 participants
Palpability of the Restorelle Direct Fix A&P Posterior - apex: Mild	1 participants
Palpability of the Restorelle Direct Fix A&P Posterior - apex: Moderate	2 participants
Palpability of the Restorelle Direct Fix A&P Posterior - apex: Severe	0 participants
Palpability of the Restorelle Direct Fix A&P Anterior - inside hymenal ring: None	30 participants
Palpability of the Restorelle Direct Fix A&P Anterior - inside hymenal ring: Mild	0 participants
Palpability of the Restorelle Direct Fix A&P Anterior - inside hymenal ring: Moderate	0 participants
Palpability of the Restorelle Direct Fix A&P Anterior - inside hymenal ring: Severe	0 participants
Palpability of the Restorelle Direct Fix A&P Anterior - 4 cm from introitus at midline: None	25 participants
Palpability of the Restorelle Direct Fix A&P Anterior - 4 cm from introitus at midline: Mild	4 participants
Palpability of the Restorelle Direct Fix A&P Anterior - 4 cm from introitus at midline: Moderat	1 participants
Palpability of the Restorelle Direct Fix A&P Anterior - 4 cm from introitus at midline: Severe	0 participants
Palpability of the Restorelle Direct Fix A&P Anterior - apex: None	25 participants

PRIMARY outcome

Timeframe: 12 months

Population: All subjects

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

Outcome measures

Measure	Restorelle Direct Fix n=30 Participants Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A \& P in the anterior and/or posterior compartment.
Palpability of the Restorelle Direct Fix A&P Anterior - inside hymenal ring: Moderate	0 participants
Palpability of the Restorelle Direct Fix A&P Anterior - inside hymenal ring: Severe	0 participants
Palpability of the Restorelle Direct Fix A&P Anterior - apex: Severe	0 participants
Palpability of the Restorelle Direct Fix A&P Anterior - inside hymenal ring: None	29 participants
Palpability of the Restorelle Direct Fix A&P Anterior - inside hymenal ring: Mild	1 participants
Palpability of the Restorelle Direct Fix A&P Anterior - 4 cm from introitus at midline: None	26 participants
Palpability of the Restorelle Direct Fix A&P Anterior - 4 cm from introitus at midline: Mild	3 participants
Palpability of the Restorelle Direct Fix A&P Anterior - 4 cm from introitus at midline: Moderat	1 participants
Palpability of the Restorelle Direct Fix A&P Anterior - 4 cm from introitus at midline: Severe	0 participants
Palpability of the Restorelle Direct Fix A&P Anterior - apex: None	26 participants
Palpability of the Restorelle Direct Fix A&P Anterior - apex: Mild	4 participants
Palpability of the Restorelle Direct Fix A&P Anterior - apex: Moderate	0 participants
Palpability of the Restorelle Direct Fix A&P Posterior - inside hymenal ring: None	29 participants
Palpability of the Restorelle Direct Fix A&P Posterior - inside hymenal ring: Mild	1 participants
Palpability of the Restorelle Direct Fix A&P Posterior - inside hymenal ring: Moderate	0 participants
Palpability of the Restorelle Direct Fix A&P Posterior - inside hymenal ring: Severe	0 participants
Palpability of the Restorelle Direct Fix A&P Posterior - 4 cm from introitus at midline: None	28 participants
Palpability of the Restorelle Direct Fix A&P Posterior - 4 cm from introitus at midline: Mild	2 participants
Palpability of the Restorelle Direct Fix A&P Posterior - 4 cm from introitus at midline: Modera	0 participants
Palpability of the Restorelle Direct Fix A&P Posterior - 4 cm from introitus at midline:Severe	0 participants
Palpability of the Restorelle Direct Fix A&P Posterior - apex: None	27 participants
Palpability of the Restorelle Direct Fix A&P Posterior - apex: Mild	3 participants
Palpability of the Restorelle Direct Fix A&P Posterior - apex: Moderate	0 participants
Palpability of the Restorelle Direct Fix A&P Posterior - apex: Severe	0 participants

SECONDARY outcome

Timeframe: 6 weeks

Population: 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 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."

Outcome measures

Measure	Restorelle Direct Fix n=12 Participants Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A \& P in the anterior and/or posterior compartment.
Rates of de Novo Dyspareunia	8.3 percentage of subjects

SECONDARY outcome

Timeframe: 3 months

Population: 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."

Outcome measures

Measure	Restorelle Direct Fix n=12 Participants Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A \& P in the anterior and/or posterior compartment.
Rates of de Novo Dyspareunia	8.3 percentage of subjects

SECONDARY outcome

Timeframe: 6 months

Population: 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."

Outcome measures

Measure	Restorelle Direct Fix n=12 Participants Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A \& P in the anterior and/or posterior compartment.
Rates of de Novo Dyspareunia	0 percentage of subjects

SECONDARY outcome

Timeframe: 12 months

Population: 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.

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."

Outcome measures

Measure	Restorelle Direct Fix n=11 Participants Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A \& P in the anterior and/or posterior compartment.
Rates of de Novo Dyspareunia	9.1 percentage of subjects

SECONDARY outcome

Timeframe: 6 weeks

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

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).

Outcome measures

Measure	Restorelle Direct Fix n=27 Participants Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A \& P in the anterior and/or posterior compartment.
Percentage of Participants With Surgical Success Rates of the Anterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at 6 Weeks	100 percentage of subjects

SECONDARY outcome

Timeframe: 3 months

Population: 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).

Outcome measures

Measure	Restorelle Direct Fix n=27 Participants Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A \& P in the anterior and/or posterior compartment.
Percentage of Participants With Surgical Success Rates of the Anterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at 3 Months	100 percentage of subjects

SECONDARY outcome

Timeframe: 6 months

Population: 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).

Outcome measures

Measure	Restorelle Direct Fix n=27 Participants Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A \& P in the anterior and/or posterior compartment.
Percentage of Participants With Surgical Success Rates of the Anterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at 6 Months	96.3 percentage of subjects

SECONDARY outcome

Timeframe: 12 months

Population: 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).

Outcome measures

Measure	Restorelle Direct Fix n=27 Participants Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A \& P in the anterior and/or posterior compartment.
Percentage of Participants With Surgical Success Rates of the Anterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at 12 Months	100 percentage of subjects

SECONDARY outcome

Timeframe: 12 months

Population: All study 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."

Outcome measures

Measure	Restorelle Direct Fix n=30 Participants Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A \& P in the anterior and/or posterior compartment.
Percentage of Participants With Mesh Exposure/Extrusion After Vaginal Reconstruction Surgery at 12 Months. Rate of mesh exposure	3.3 percentage of subjects
Percentage of Participants With Mesh Exposure/Extrusion After Vaginal Reconstruction Surgery at 12 Months. Rate of mesh extrusion	0.0 percentage of subjects

SECONDARY outcome

Timeframe: 6 week

Population: 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 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).

Outcome measures

Measure	Restorelle Direct Fix n=6 Participants Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A \& P in the anterior and/or posterior compartment.
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	100 percentage of subjects

SECONDARY outcome

Timeframe: 3 month

Population: 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 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).

Outcome measures

Measure	Restorelle Direct Fix n=6 Participants Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A \& P in the anterior and/or posterior compartment.
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	100 percentage of subjects

SECONDARY outcome

Timeframe: 6 month

Population: 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 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).

Outcome measures

Measure	Restorelle Direct Fix n=5 Participants Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A \& P in the anterior and/or posterior compartment.
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	100 percentage of subjects

SECONDARY outcome

Timeframe: 12 month

Population: 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 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).

Outcome measures

Measure	Restorelle Direct Fix n=6 Participants Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A \& P in the anterior and/or posterior compartment.
Percentage of Participants With Surgical Success of the Posterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at the12 Month Visit	100 percentage of subjects

SECONDARY outcome

Timeframe: 6 weeks

Population: 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 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.

Outcome measures

Measure	Restorelle Direct Fix n=29 Participants Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A \& P in the anterior and/or posterior compartment.
Patient Global Impression of Improvement (PGI-I) Questionnaire Since Treatment at 6 Weeks. Very much better	15 participants
Patient Global Impression of Improvement (PGI-I) Questionnaire Since Treatment at 6 Weeks. Much better	10 participants
Patient Global Impression of Improvement (PGI-I) Questionnaire Since Treatment at 6 Weeks. A little better	1 participants
Patient Global Impression of Improvement (PGI-I) Questionnaire Since Treatment at 6 Weeks. No change	1 participants
Patient Global Impression of Improvement (PGI-I) Questionnaire Since Treatment at 6 Weeks. A little worse	0 participants
Patient Global Impression of Improvement (PGI-I) Questionnaire Since Treatment at 6 Weeks. Much worse	2 participants
Patient Global Impression of Improvement (PGI-I) Questionnaire Since Treatment at 6 Weeks. Very much worse	0 participants

SECONDARY outcome

Timeframe: 3 months

Population: 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 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.

Outcome measures

Measure	Restorelle Direct Fix n=29 Participants Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A \& P in the anterior and/or posterior compartment.
Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 3 Months. Very much better	14 participants
Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 3 Months. Much better	9 participants
Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 3 Months. A little better	2 participants
Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 3 Months. No change	3 participants
Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 3 Months. A little worse	1 participants
Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 3 Months. Much worse	0 participants
Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 3 Months. Very much worse	0 participants

SECONDARY outcome

Timeframe: 6 months

Population: 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 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.

Outcome measures

Measure	Restorelle Direct Fix n=29 Participants Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A \& P in the anterior and/or posterior compartment.
Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 6 Months. Very much better	12 participants
Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 6 Months. Much better	7 participants
Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 6 Months. A little better	6 participants
Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 6 Months. No change	2 participants
Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 6 Months. A little worse	1 participants
Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 6 Months. Much worse	1 participants
Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 6 Months. Very much worse	0 participants

SECONDARY outcome

Timeframe: 12 months

Population: All subjects

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.

Outcome measures

Measure	Restorelle Direct Fix n=30 Participants Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A \& P in the anterior and/or posterior compartment.
Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 12 Months. Very much better	18 participants
Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 12 Months. Much better	4 participants
Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 12 Months. A little better	4 participants
Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 12 Months. No change	3 participants
Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 12 Months. A little worse	1 participants
Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 12 Months. Much worse	0 participants
Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 12 Months. Very much worse	0 participants

SECONDARY outcome

Timeframe: Baseline and 6 weeks

Population: 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.

Outcome measures

Measure	Restorelle Direct Fix n=30 Participants Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A \& P in the anterior and/or posterior compartment.
Bladder Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Urinary Distress Inventory-6 (UDI-6) Questionnaire at 6 Weeks Baseline	45.1 units on a scale Standard Deviation 27.2
Bladder Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Urinary Distress Inventory-6 (UDI-6) Questionnaire at 6 Weeks 6 weeks	25.7 units on a scale Standard Deviation 19.0

SECONDARY outcome

Timeframe: Baseline and 3 months

Population: 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.

Outcome measures

Measure	Restorelle Direct Fix n=30 Participants Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A \& P in the anterior and/or posterior compartment.
Bladder Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Urinary Distress Inventory-6 (UDI-6) Questionnaire at 3 Months Baseline	45.1 units on a scale Standard Deviation 27.2
Bladder Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Urinary Distress Inventory-6 (UDI-6) Questionnaire at 3 Months 3 months	17.1 units on a scale Standard Deviation 17.3

SECONDARY outcome

Timeframe: Baseline and 6 months

Population: 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.

Outcome measures

Measure	Restorelle Direct Fix n=30 Participants Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A \& P in the anterior and/or posterior compartment.
Bladder Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Urinary Distress Inventory-6 (UDI-6) Questionnaire at 6 Months Baseline	45.1 units on a scale Standard Deviation 27.2
Bladder Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Urinary Distress Inventory-6 (UDI-6) Questionnaire at 6 Months 6 months	16.4 units on a scale Standard Deviation 18.7

SECONDARY outcome

Timeframe: Baseline and 12 months

Population: 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.

Outcome measures

Measure	Restorelle Direct Fix n=30 Participants Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A \& P in the anterior and/or posterior compartment.
Bladder Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Urinary Distress Inventory-6 (UDI-6) Questionnaire at 12 Months Baseline	45.1 units on a scale Standard Deviation 27.2
Bladder Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Urinary Distress Inventory-6 (UDI-6) Questionnaire at 12 Months 12 months	18.1 units on a scale Standard Deviation 21.3

SECONDARY outcome

Timeframe: Baseline and 6 weeks

Population: 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 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.

Outcome measures

Measure	Restorelle Direct Fix n=28 Participants Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A \& P in the anterior and/or posterior compartment.
Sexual Function After Vaginal Reconstruction With Restorelle Direct Fix Measured by Participant Sexual Function Questionnaire-12 (PISQ-12) at 6 Weeks Baseline	15.7 units on a scale Standard Deviation 6.2
Sexual Function After Vaginal Reconstruction With Restorelle Direct Fix Measured by Participant Sexual Function Questionnaire-12 (PISQ-12) at 6 Weeks 6 weeks	14.7 units on a scale Standard Deviation 4.9

SECONDARY outcome

Timeframe: Baseline and 3 months

Population: 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 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.

Outcome measures

Measure	Restorelle Direct Fix n=25 Participants Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A \& P in the anterior and/or posterior compartment.
Sexual Function After Vaginal Reconstruction With Restorelle Direct Fix Measured by Participant Sexual Function Questionnaire-12 (PISQ-12) at 3 Months 3 month	12.2 units on a scale Standard Deviation 5.2
Sexual Function After Vaginal Reconstruction With Restorelle Direct Fix Measured by Participant Sexual Function Questionnaire-12 (PISQ-12) at 3 Months Baseline	15.7 units on a scale Standard Deviation 6.2

SECONDARY outcome

Timeframe: Baseline and 6 months

Population: 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 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.

Outcome measures

Measure	Restorelle Direct Fix n=26 Participants Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A \& P in the anterior and/or posterior compartment.
Sexual Function After Vaginal Reconstruction With Restorelle Direct Fix Measured by Participant Sexual Function Questionnaire-12 (PISQ-12) at 6 Months 6 months	12.8 units on a scale Standard Deviation 5.4
Sexual Function After Vaginal Reconstruction With Restorelle Direct Fix Measured by Participant Sexual Function Questionnaire-12 (PISQ-12) at 6 Months Baseline	15.7 units on a scale Standard Deviation 6.2

SECONDARY outcome

Timeframe: Baseline and 12 months

Population: The 25 subjects who completed the PISQ-12 at the twelve 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.

Outcome measures

Measure	Restorelle Direct Fix n=25 Participants Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A \& P in the anterior and/or posterior compartment.
Sexual Function After Vaginal Reconstruction With Restorelle Direct Fix Measured by Participant Sexual Function Questionnaire-12 (PISQ-12) at 12 Months 12 month	12.8 units on a scale Standard Deviation 6.2
Sexual Function After Vaginal Reconstruction With Restorelle Direct Fix Measured by Participant Sexual Function Questionnaire-12 (PISQ-12) at 12 Months Baseline	15.7 units on a scale Standard Deviation 6.2

SECONDARY outcome

Timeframe: Baseline and 6 weeks

Population: All subjects

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).

Outcome measures

Measure	Restorelle Direct Fix n=30 Participants Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A \& P in the anterior and/or posterior compartment.
Bowel Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Colorectal-Anal Distress Inventory 8 (CRADI-8) Questionnaire at the 6 Week Visit Baseline	24.9 units on a scale Standard Deviation 20.7
Bowel Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Colorectal-Anal Distress Inventory 8 (CRADI-8) Questionnaire at the 6 Week Visit 6 weeks	15.7 units on a scale Standard Deviation 15.7

SECONDARY outcome

Timeframe: Baseline and 3 months

Population: 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).

Outcome measures

Measure	Restorelle Direct Fix n=30 Participants Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A \& P in the anterior and/or posterior compartment.
Bowel Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Colorectal-Anal Distress Inventory 8 (CRADI-8) Questionnaire at the 3 Month Visit Baseline	24.9 units on a scale Standard Deviation 20.7
Bowel Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Colorectal-Anal Distress Inventory 8 (CRADI-8) Questionnaire at the 3 Month Visit 3 months	15.3 units on a scale Standard Deviation 16.7

SECONDARY outcome

Timeframe: Baseline and 6 months

Population: 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).

Outcome measures

Measure	Restorelle Direct Fix n=30 Participants Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A \& P in the anterior and/or posterior compartment.
Bowel Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Colorectal-Anal Distress Inventory 8 (CRADI-8) Questionnaire at the 6 Month Visit Baseline	24.9 units on a scale Standard Deviation 20.7
Bowel Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Colorectal-Anal Distress Inventory 8 (CRADI-8) Questionnaire at the 6 Month Visit 6 months	14.1 units on a scale Standard Deviation 16.1

SECONDARY outcome

Timeframe: Baseline and 12 months

Population: 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).

Outcome measures

Measure	Restorelle Direct Fix n=30 Participants Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A \& P in the anterior and/or posterior compartment.
Bowel Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Colorectal-Anal Distress Inventory 8 (CRADI-8) Questionnaire at the12 Month Visit Baseline	24.9 units on a scale Standard Deviation 20.7
Bowel Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Colorectal-Anal Distress Inventory 8 (CRADI-8) Questionnaire at the12 Month Visit 12 months	10.8 units on a scale Standard Deviation 14.0

Adverse Events

Restorelle Direct Fix

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Restorelle Direct Fix n=30 participants at risk Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A \& P in the anterior and/or posterior compartment.
Reproductive system and breast disorders Recurrent prolapse: Anterior Stage 2	3.3% 1/30 • Number of events 1
Reproductive system and breast disorders Right ureteral obstruction, hydronephrosis	3.3% 1/30 • Number of events 1

Other adverse events

Measure	Restorelle Direct Fix n=30 participants at risk Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A \& P in the anterior and/or posterior compartment.
Reproductive system and breast disorders Recurrent anterior prolapse	6.7% 2/30 • Number of events 2
Reproductive system and breast disorders Wound dehiscence	3.3% 1/30 • Number of events 1

Additional Information

Cathy Bartz

Coloplast Corp

Phone: 612-834-3127

Email: uscmba@coloplast.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60