Uphold LITE Post-Market Surveillance Study

Pelvic Organ Prolapse Clinical Trial

— Uphold LITE  

Official title:

A Prospective, Non-Randomized, Parallel Cohort, Multi-center Study of Uphold LITE Versus Native Tissue for the Treatment of Women With Anterior/Apical Pelvic Organ Prolapse

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01917968
• Other study ID #: U8090
• Status: Completed
• Phase: N/A
• Start date: October 10, 2013
• Est. completion date: February 12, 2020

Study information

• Verified date: April 2021
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 289
• Est. completion date: February 12, 2020
• Est. primary completion date: February 12, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

1. Subject is female

2. Subject is =18 years of age

3. Subject has pelvic organ prolapse with the leading edge at or beyond the hymen. At or beyond the hymen is defined as POP-Q scores of Ba=0 or (for prolapse of the anterior compartment alone) C=0 (for prolapse of the apical compartment alone) or C=-1/2 TVL and Ba=0 (for a multi-compartment prolapse that includes the anterior and apical compartments).

4. Subject reports of a bothersome bulge they can see or feel per PFDI-20, question 3 response of 2 or higher (i.e. responses of "somewhat", "moderately" or "quite a bit")

5. Subject or subject's legally authorized representative must be willing to provide written informed consent

6. Subject is willing and able to comply with the follow-up regimen

Exclusion Criteria:

1. Subject has an active or chronic systemic infection including any gynecologic infection, untreated urinary tract infection (UTI) or tissue necrosis

2. Subject has history of pelvic organ cancer (e.g. uterine, ovarian, bladder, colo-rectal or cervical)

3. Subject has had prior or is currently undergoing radiation, laser therapy, or chemotherapy in the pelvic area

4. Subject has taken systemic steroids (within the last month) or immunosuppressive or immunomodulatory treatment (within the last 3 months)

5. Subject has systemic connective tissue disease (e.g. scleroderma, systemic lupus erythematosus (SLE), Marfans syndrome, Ehlers Danlos, collagenosis, polymyositis polymyalgia rheumatica)

6. Subject has a known neurologic or medical condition affecting bladder function (e.g. multiple sclerosis, spinal cord injury, or stroke with residual neurologic deficit)

7. Subject is seeking obliterative vaginal surgery as treatment for pelvic organ prolapse (colpocleisis)

8. Subject has a previous prolapse repair with mesh in the target compartment

9. Subject is planning to undergo a concomitant repair with use of mesh in the non-target compartment

10. Subject is not able to conform to the modified dorsal lithotomy position

11. Subject has chronic systemic pain that includes the pelvic area or chronic focal pain that includes the pelvis

12. Subject has uncontrolled diabetes mellitus (DM)

13. Subject is currently participating in or plans to participate in another device or drug study during this study

14. Subject has a known hypersensitivity to polypropylene mesh

15. Subject is pregnant or intends to become pregnant during the study

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

Device:
• Uphold Lightweight Vaginal Support System
Pelvic organ prolapse repair via transvaginal mesh (Uphold LITE)

Procedure:
• Traditional native tissue repair
Sarcrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy

Locations

Country	Name	City	State
United States	Institute for Female Pelvic Medicine & Reconstructive Surgery	Allentown	Pennsylvania
United States	University of Alabama at Birmingham Kirklin Clinic	Birmingham	Alabama
United States	St. Alexius Medical Center/Mid Dakota Clinic	Bismarck	North Dakota
United States	Holston Medical Group at Seasons Center for Urogynecology & Advanced Pelvic Surgery	Bristol	Tennessee
United States	Presbyterian Hospital	Charlotte	North Carolina
United States	University of Cincinnati Physicians Co	Cincinnati	Ohio
United States	MultiCare Women's Health Care	Covington	Washington
United States	NorthShore University HealthSystem	Evanston	Illinois
United States	Capital Women's Care - Frederick	Frederick	Maryland
United States	Prisma Health System	Greenville	South Carolina
United States	UCSD Health/Women's Pelvic Medicine Center	La Jolla	California
United States	Las Vegas Minimally Invasive Surgery Women's Pelvic Health Center	Las Vegas	Nevada
United States	Montgomery Women's Health Associates, PC	Montgomery	Alabama
United States	Dr. M. Mitchell Silver, FACOG, PA	Nacogdoches	Texas
United States	Kyle P. McMorries, MD	Nacogdoches	Texas
United States	The Florida Bladder Institute	Naples	Florida
United States	Columbia University Irving Medical Center/NY Presbyterian Hospital	New York	New York
United States	Sherry Thomas, PC	North Hollywood	California
United States	Institute for Female Pelvic Medicine & Reconstructive Surgery	North Wales	Pennsylvania
United States	University of CA Irvine Medical Center	Orange	California
United States	Women's OB/GYN Center	Pasadena	Texas
United States	Kaiser Permanente OB/GYN Urogynecology	San Diego	California
United States	Scripps Clinic Carmel Valley	San Diego	California
United States	Regional Urology, LLC	Shreveport	Louisiana
United States	Cooper University Hospital	Voorhees	New Jersey
United States	MedStar Washington Hospital Center	Washington	District of Columbia
United States	Aurora West Allis Medical Center	West Allis	Wisconsin
United States	Lyndhurst Clinical Research	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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: 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.; 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).; 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).	36 Months
Primary	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	36 months
Secondary	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.	6 Month, 12 Months, 18 Months, 24 Months, 36 Months, Overall
Secondary	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.	36 Months
Secondary	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.	6 Month, 12 Months, 18 Months, 24 Months, 36 Months
Secondary	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.	6 Month, 12 Months, 18 Months, 24 Months, 36 Months
Secondary	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.	6 Month, 12 Months, 18 Months, 24 Months, 36 Months
Secondary	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.	6 Month, 12 Months, 18 Months, 24 Months, 36 Months
Secondary	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.	6 Month, 12 Months, 18 Months, 24 Months, 36 Months
Secondary	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.	36 Months
Secondary	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).	36 Months