N/A
N=698
Pelvic Floor Repair Systems for Prolapse Repair
Pelvic Organ Prolapse
Bottom Line
View on ClinicalTrials.gov: NCT00638235 ↗Enrolled (actual)
698
Serious AEs
8.0%
Results posted
Oct 2016
Primary outcome: Primary: Percent of Subjects With an ICS (International Incontinence Society) POP-Q (Pelvic Organ Prolapse Quantification System) Stage of </= Stage I in the Posterior Compartment at One Year Post Procedure — 93.2; 100; 93.2; 92.5 percentage of participant
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- AMS Apogee™ with IntePro (Device); AMS Apogee™ with Intexen LP (Device); AMS Perigee™ with IntePro (Device); AMS Perigee™ with IntePro Lite (Device); AMS Apogee™ with IntePro Lite (Device); AMS Elevate™ Apical & Posteiror with IntePro Lite (Device); AMS Elevate™ Apical & Posteiror with IntXen LP (Device); AMS Elevate™ Anterior & Apical with IntePro Lite (Gen 1, For Study Use Only) (Device); AMS Elevate™ Anterior & Apical with IntePro Lite (Gen 2) (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- Female
- Sponsor
- ASTORA Women's Health
- Primary completion
- Feb 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Subjects With an ICS (International Incontinence Society) POP-Q (Pelvic Organ Prolapse Quantification System) Stage of </= Stage I in the Posterior Compartment at One Year Post Procedure |
93.2; 100; 93.2; 92.5; 100 | — |
| PRIMARY Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Apical Compartment at One Year Post Procedure |
86.1; 100; 100; 89.2; 90.9; 90.0 | — |
| PRIMARY Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Anterior Compartment at One Year Post Procedure |
71.2; 85.1; 58.8; 87.4 | — |
| SECONDARY QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 |
32.4; 31.7; 34.5; 32.4; 31.9; 34.9 | — |
| SECONDARY Procedural Time |
44.8; 40.8; 50.2; 42.4; 51.7; 45.8 | — |
| SECONDARY Estimated Blood Loss |
68.6; 67.7; 48.8; 58.4; 58.9; 55.4 | — |
| SECONDARY Percent of Subjects Experiencing Major Device Related Complications |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Rate of Graft Extrusions |
9.2; 0; 3.7; 5.4; 7.3; 7.9 | — |
| SECONDARY Rates of de Novo or Worsening Urinary and/or Anal Incontinence |
0; 3.8; 12.3; 1.8; 0; 0 | — |
| SECONDARY Wong-Baker Faces Pain Scale at 6 Weeks Post Procedure |
1.9; 2.0; 1.5; 1.2; 1.4; 1.8 | — |
| SECONDARY Patient Satisfaction Questionnaire at 6 Months by Question (Q#1) |
0.8; 0; 5.5; 0; 0; 2.3 | — |
| SECONDARY Surgical Revision Rate |
7.1; 0; 11.1; 5.4; 3.6; 8.6 | — |
| SECONDARY Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 6 Months |
94.4; 100; NA; NA; 91.3; 96.8 | — |
| SECONDARY Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 24 Months |
93.5; 95.7; NA; NA; 90.9; 91.5 | — |
| SECONDARY Patient Satisfaction Questionnaire at 12 Months by Question (Q#1) |
0; 4.2; 7.0; 0; 0; 1.6 | — |
| SECONDARY Patient Satisfaction Questionnaire at 24 Months by Question (Q#1) |
0; 4.3; 11.1; 2.2; 0; 0.9 | — |
| SECONDARY Patient Satisfaction Questionnaire at 6 Months by Question (Q#2) |
0.8; 0; 5.5; 0; 0; 2.3 | — |
| SECONDARY Patient Satisfaction Questionnaire at 12 Months by Question (Q#2) |
0; 4.2; 7.0; 0; 0; 0.8 | — |
| SECONDARY Patient Satisfaction Questionnaire at 24 Months by Question (Q#2) |
0; 4.3; 11.1; 2.2; 0; 0.9 | — |
| SECONDARY Patient Satisfaction Questionnaire at 6 Months by Question (Q#3) |
2.3; 0; 5.5; 0; 0; 2.3 | — |
| SECONDARY Patient Satisfaction Questionnaire at 12 Months by Question (Q#3) |
1.7; 4.2; 7.0; 0; 0; 2.4 | — |
| SECONDARY Patient Satisfaction Questionnaire at 24 Months by Question (Q#3) |
0.9; 4.3; 11.1; 2.2; 0; 0.9 | — |
| SECONDARY Wong-Baker Faces Pain Scale at 3 Months Post Procedure |
1.9; 2.0; 1.5; 1.2; 1.6; 1.7 | — |
| SECONDARY QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 |
32.4; 31.7; 34.5; 32.4; 31.9; 34.9 | — |
| SECONDARY QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 |
32.4; 31.7; 34.5; 32.4; 31.9; 34.9 | — |
| SECONDARY QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 6M |
70.4; 68.2; 54.9; 61.5; 58.9; 65.4 | — |
| SECONDARY QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 12M |
64.9; 59.3; 59.1; 61.7; 57.5; 65.6 | — |
| SECONDARY QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 24M |
59.1; 55.6; 60.9; 56.5; 59.0; 64.3 | — |
| SECONDARY QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI (Pelvic Floor Distress Inventory) Sub-scale UDI (Urinary Distress Inventory) at 6M |
98.4; 106.7; 65.5; 93.2; 93.0; 97.6 | — |
| SECONDARY QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale UDI (Urinary Distress Inventory) at 12M |
97.5; 103.6; 66.7; 92.4; 93.4; 97.6 | — |
| SECONDARY QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale UDI (Urinary Distress Inventory) at 24M |
96.5; 94.9; 69.9; 89.6; 95.8; 97.6 | — |
| SECONDARY QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 6M |
137.0; 128.9; 102.3; 112.0; 115.7; 122.7 | — |
| SECONDARY QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 6M |
129.6; 125.8; 52.6; 82.4; 94.1; 110.0 | — |
| SECONDARY QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 12M |
135.1; 128.2; 103.3; 105.7; 116.1; 122.0 | — |
| SECONDARY QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 24M |
132.4; 113.2; 107.4; 104.7; 116.1; 121.7 | — |
| SECONDARY QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 12M |
129.8; 123.5; 50.9; 85.1; 100.8; 108.2 | — |
| SECONDARY QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 24M |
126.9; 110.6; 58.3; 79.8; 95.5; 105.9 | — |
| SECONDARY Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Posterior Compartment at 6M Post Procedure |
94.4; 100; 91.3; 96.8; 100 | — |
| SECONDARY Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Posterior Compartment at 24M Post Procedure |
93.5; 95.7; 90.9; 91.5; 100 | — |
| SECONDARY Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Anterior Compartment at 6M Post Procedure |
76.7; 91.5; 61.8; 86.3 | — |
| SECONDARY Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Anterior Compartment at 24M Post Procedure |
69.1; 87.0; 81.6 | — |
Summary
1. This is a prospective, multi-center, post market study, which will be conducted under a common protocol.
2. The primary objective of the study is to evaluate long-term efficacy of the AMS Pelvic Floor Repair System devices for prolapse repair.
3. The study population is female subjects > 21 years of age who require surgical reconstruction of their pelvic floor due to prolapse.
4. The clinical data will be analyzed by comparing post-treatment data with the baseline data, with the subject acting as her own control. The follow-up is for two years after the procedure.
5. Prolapse improvement measured by ICS POP-Q Stage at 12-months will be the primary endpoint of the study. The secondary endpoints include quality of life changes from baseline and adverse event rates.
Eligibility Criteria
Inclusion Criteria
-Have been diagnosed with one or more clinically significant anterior, apical or posterior genital prolapse disorder(s) (symptomatic POP-Q stage II or higher) requiring surgical repair
Exclusion Criteria
- The Investigator determines the subject is not a candidate for surgical repair of her genital prolapse.
- Subject has had a prior prolapse implant/procedure (i.e., IVS tunneler, Perigee, Apogee, graft augmented repair, etc) Note: previous traditional repairs are allowed.
- Subject has active or latent systemic infection or signs of tissue necrosis.
- Subject has restricted leg motion (inability to abduct or adduct leg positioning in the lithotomy position) with or without a hip replacement/prosthesis.
- Subject is currently pregnant or intends to become pregnant during the study period. Note: the risks and benefits of performing the procedure if the subject is planning future pregnancies should be carefully considered.
- Subject has had radiation therapy to the pelvic area.
- Subject has pelvic cancer, has had pelvic cancer within the past 12 months or has been on cytostatic medication within the past 12 months.
- Subject has a known hypersensitivity to the graft material(s).
- Subject has uncontrolled diabetes.
- Subject is on any medication which could result in compromised immune response, such as immune modulators.
- Subject was involved in any other research trial < 30 days of enrollment into this study.
- Subject has undergone previous pelvic surgery < 6 months prior to enrollment in this study.
- Subject is unwilling or unable to give valid informed consent.
- Subject is unwilling or unable to comply with the requirements of the protocol, complete all Quality of Life questionnaires and return for all follow-up visits.
- Subject is contraindicated based on intended use and warnings in the AMS PFR System devices for prolapse repair Instructions for Use (IFU).
Data sourced from ClinicalTrials.gov (NCT00638235). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.