The purpose of this study is to compare transvaginal mesh repair to traditional native tissue repair in women surgically treated for anterior and/or apical pelvic organ prolapse.
The primary objective is to evaluate clinical effectiveness of transvaginal repair with mesh (Uphold LITE) against traditional native tissue repair in women surgically treated for anterior and/or apical pelvic organ prolapse. Secondary objectives are to evaluate Uphold LITE-related complications and subject reported outcomes. The primary endpoint of the study is to achieve superiority of transvaginal repair with mesh (Uphold LITE) over native tissue repair at 36 months as compared to baseline. Success will be based on a composite of objective and subjective measures. Additionally, a co-primary endpoint of the study is to achieve non-inferiority of transvaginal repair with mesh (Uphold LITE) to native tissue repair for safety by comparing rates of serious device or serious procedure related complications between baseline and the 36 month time point. The secondary endpoints of the study include assessments of complications and subject reported outcomes.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
289
Pelvic organ prolapse repair via transvaginal mesh (Uphold LITE)
Sarcrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy
Primary Efficacy Endpoint - Number of Participants With Composite Anatomic and Symptomatic Success at 36 Months
Success based on a composite of objective and subjective measures: 1. Objective success was achieved by the subject having an anatomic outcome defined as the leading edge of prolapse at or above the hymen in the operated compartment: * Anterior segment: Leading edge of anterior prolapse was at or above the hymen or POP-Q point Ba ≤ 0. * Apical segment: The vaginal apex did not descend more than one-half into the vaginal canal (i.e., POP-Q point C \< -1/2 TVL) for multi-compartment prolapse or POP-Q point C ≤ 0 for single compartment apical prolapse. 2. Subjective success was achieved if the patient denied symptoms of vaginal bulging per Pelvic Floor Distress Inventory (PFDI-20) question 3, answering "no" or "yes" but "Not at all" bothersome (\< 2). 3. No retreatment for POP: no additional surgical treatment for POP in the segment(s) of the vagina treated at the index surgery or no pessary use since index surgery (i.e., 'treated segment' refers to the target compartment).
Time frame: 36 Months
Co-Primary Safety Endpoint - Number of Participants With One or More Serious Device-Related and/or Procedure-Related Complications at 36 Months
A co-primary endpoint of the study was to achieve non-inferiority of transvaginal repair with Uphold LITE vs. NTR for safety by comparing the overall complication rate (device-related and/or procedure-related SAEs) at 36 months
Time frame: 36 months
Secondary Endpoint - Number of Participants With Mesh Erosion and Exposures Over Time in Intent-to-Treat Subjects
Provides a summary of the number of subjects who reported mesh erosion or exposure at each of the study follow-up time points.
Time frame: 6 Month, 12 Months, 18 Months, 24 Months, 36 Months, Overall
Secondary Endpoint - Number of Participants With One or More Device-Related and/or Procedure-Related Adverse Events
Number of subjects with the following device-related and/or procedure-related adverse events: de novo dyspareunia, pelvic pain, infection, vaginal shortening, atypical vaginal discharge, neuromuscular problems, vaginal scarring, de novo vaginal bleeding, fistula formation, and/or de novo voiding dysfunction. The Intent-to-Treat (ITT) population includes all enrolled subjects who had a surgery initiated; the As Treated population includes all subjects who successfully completed the surgical procedure. Both ITT and As Treated populations are identical to the Overall Number of Participants Analyzed.
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University of Alabama at Birmingham Kirklin Clinic
Birmingham, Alabama, United States
Montgomery Women's Health Associates, PC
Montgomery, Alabama, United States
UCSD Health/Women's Pelvic Medicine Center
La Jolla, California, United States
Sherry Thomas, PC
North Hollywood, California, United States
University of CA Irvine Medical Center
Orange, California, United States
Kaiser Permanente OB/GYN Urogynecology
San Diego, California, United States
Scripps Clinic Carmel Valley
San Diego, California, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
The Florida Bladder Institute
Naples, Florida, United States
NorthShore University HealthSystem
Evanston, Illinois, United States
...and 18 more locations
Time frame: 36 Months
Secondary Endpoint - PFDI-20 Change From Baseline in Intent-to-Treat Subjects
The Pelvic Floor Distress Inventory-20 (PFDI-20) consists of three components: Pelvic Organ Prolapse Distress Inventory (POPDI; 6 questions), Urinary Distress Inventory (UDI; 6 questions), and Colorectal-Anal Distress Inventory (CRADI; 8 questions). Each individual component score is summed. The total ranges from 0 to 300, with a higher score indicating a greater impact to QOL (i.e., distress symptoms are more noticeable) and a lower score indicating a lesser impact to QOL (i.e., distress symptoms are less noticeable). Reported outcomes are the change from Baseline for the time periods indicated.
Time frame: 6 Month, 12 Months, 18 Months, 24 Months, 36 Months
Secondary Endpoint - PFIQ-7 Change From Baseline in Intent-to-Treat Subjects
The Pelvic Floor Impact Questionnaire (PFIQ-7) is composed of 3 separate but related assessments: the Urinary Impact Questionnaire, addresses the impact of urinary incontinence symptoms, the Colorectal-Anal Impact Questionnaire addresses the impact of colorectal-anal or bowel symptoms, and the Pelvic Organ Prolapse Impact Questionnaire addresses impact of vaginal and pelvic symptoms. For each question, the low score (0) corresponds to "not at all" and the high score (3) corresponds to "quite a bit". The scores for the UIQ-7, CRAIQ-7 and POPIQ-7 are additive to yield the final PFIQ-7 score, which ranges from 0-300. A lower score means there is a lesser effect on quality of life.
Time frame: 6 Month, 12 Months, 18 Months, 24 Months, 36 Months
Secondary Endpoint - PISQ-12 Change From Baseline in Intent-to-Treat Subjects
The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) is a validated short form that can be used to ascertain improvement in sexual function and desire in women undergoing therapy for pelvic organ prolapse. The PISQ-12 consists of 12 questions graded on a five-point Likert scale ranging from 0 (always) to 4 (never). Values range from 0-48 and a higher score indicates better sexual function. Reported outcomes are the change from Baseline for the time periods indicated.
Time frame: 6 Month, 12 Months, 18 Months, 24 Months, 36 Months
Secondary Endpoint - TOMUS Pain Score Change From Baseline in Intent-to-Treat Subjects
The TOMUS Pain Score, a visual analog instrument with a scale of 0 (no pain sensation) to 10 (most intense pain sensation imaginable), was used to assess pain associated with surgery for pelvic organ prolapse. There are seven (7) questions each with a maximum score of 10 and a possible score range of 0-70. Reported outcomes are the change from Baseline for the time periods indicated.
Time frame: 6 Month, 12 Months, 18 Months, 24 Months, 36 Months
Secondary Endpoint: PGI-I for Prolapse Symptoms in Intent-to-Treat Subjects
The Patient Global Impression of Improvement (PGI-I) for prolapse symptoms is a validated QOL instrument that assesses patient perception of overall improvement after surgical interventions for pelvic organ prolapse. The scale is as follows: 1- Very much better; 2- Much better; 3- A little better; 4- No change; 5- A little worse; 6- Much worse; 7- Very much worse.
Time frame: 6 Month, 12 Months, 18 Months, 24 Months, 36 Months
Secondary Endpoint - Number of Participants With Intervention for Recurrent Prolapse and Complications at 36 Months Post Index Procedure
Compares the office-based and surgical intervention for recurrent prolapse and complications between the Uphold LITE arm and the NTR arm 36 months from the index procedure in the Intent-to-Treat (ITT) and As Treated populations. The ITT population includes all enrolled subjects who had a surgery initiated; the As Treated population includes all subjects who successfully completed the surgical procedure. Both ITT and As Treated populations are identical to the Overall Number of Participants Analyzed.
Time frame: 36 Months
Secondary Efficacy Endpoint - Number of Participants With Composite Anatomic and Symptomatic Success at 36 Months
Secondary efficacy endpoint defined similarly to the primary efficacy endpoint except for the definition of objective success. Objective success for this endpoint is defined as: * Anatomic success in the operated compartment was achieved by: * Anterior segment: No anterior prolapse at or beyond the hymen or POP-Q point Ba \< 0. * Apical segment: The vaginal apex did not descend more than one-half into the vaginal canal (i.e., POP-Q point C \< -1/2 TVL) for multi-compartment prolapse or POP-Q point C \< 0 for single compartment apical prolapse. * Subjective success was achieved if the patient denied symptoms of vaginal bulging per PFDI-20 question 3, answering "no" or "yes" but "Not at all" bothersome (\< 2). * No retreatment for POP: No additional surgical treatment for POP in segment(s) of the vagina treated at the index surgery or no pessary use since index surgery ('treated segment' refers to the target compartments in this study, which are the anterior and apical compartments).
Time frame: 36 Months