Pelvic Organ ProlapseUphold LITENCT01917968
Uphold LITE Post-Market Surveillance Study
A study testing Uphold Lightweight Vaginal Support System and Traditional native tissue repair in people with Pelvic Organ Prolapse, run by Boston Scientific Corporation at 28 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Uphold Lightweight Vaginal Support System and Traditional native tissue repair
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 289 participants
- Where
- 28 sitesUnited States
- Study dates
- 10 Oct 2013to 12 Feb 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is female
- Subject is ≥18 years of age
- 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).
- 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")
- Subject or subject's legally authorized representative must be willing to provide written informed consent
- Subject is willing and able to comply with the follow-up regimen
Who cannot join
- Subject has an active or chronic systemic infection including any gynecologic infection, untreated urinary tract infection (UTI) or tissue necrosis
- Subject has history of pelvic organ cancer (e.g. uterine, ovarian, bladder, colo-rectal or cervical)
- Subject has had prior or is currently undergoing radiation, laser therapy, or chemotherapy in the pelvic area
- Subject has taken systemic steroids (within the last month) or immunosuppressive or immunomodulatory treatment (within the last 3 months)
- Subject has systemic connective tissue disease (e.g. scleroderma, systemic lupus erythematosus (SLE), Marfans syndrome, Ehlers Danlos, collagenosis, polymyositis polymyalgia rheumatica)
- Subject has a known neurologic or medical condition affecting bladder function (e.g. multiple sclerosis, spinal cord injury, or stroke with residual neurologic deficit)
Show all 15Show fewer
- Subject is seeking obliterative vaginal surgery as treatment for pelvic organ prolapse (colpocleisis)
- Subject has a previous prolapse repair with mesh in the target compartment
- Subject is planning to undergo a concomitant repair with use of mesh in the non-target compartment
- Subject is not able to conform to the modified dorsal lithotomy position
- Subject has chronic systemic pain that includes the pelvic area or chronic focal pain that includes the pelvis
- Subject has uncontrolled diabetes mellitus (DM)
- Subject is currently participating in or plans to participate in another device or drug study during this study
- Subject has a known hypersensitivity to polypropylene mesh
- Subject is pregnant or intends to become pregnant during the study
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
United States28 sites
Institute for Female Pelvic Medicine & Reconstructive Surgery
Allentown, Pennsylvania, 18103
University of Alabama at Birmingham Kirklin Clinic
Birmingham, Alabama, 35233
St. Alexius Medical Center/Mid Dakota Clinic
Bismarck, North Dakota, 58501
Holston Medical Group at Seasons Center for Urogynecology & Advanced Pelvic Surgery
Bristol, Tennessee, 37620
Presbyterian Hospital
Charlotte, North Carolina, 28210
University of Cincinnati Physicians Co
Cincinnati, Ohio, 45267
MultiCare Women's Health Care
Covington, Washington, 98042
NorthShore University HealthSystem
Evanston, Illinois, 60201
Capital Women's Care - Frederick
Frederick, Maryland, 21702
Prisma Health System
Greenville, South Carolina, 29605
UCSD Health/Women's Pelvic Medicine Center
La Jolla, California, 92037
Las Vegas Minimally Invasive Surgery Women's Pelvic Health Center
Las Vegas, Nevada, 89135
Montgomery Women's Health Associates, PC
Montgomery, Alabama, 36117
Dr. M. Mitchell Silver, FACOG, PA
Nacogdoches, Texas, 25965
Kyle P. McMorries, MD
Nacogdoches, Texas, 75965
The Florida Bladder Institute
Naples, Florida, 34109
Columbia University Irving Medical Center/NY Presbyterian Hospital
New York, New York, 10032
Sherry Thomas, PC
North Hollywood, California, 91301
Institute for Female Pelvic Medicine & Reconstructive Surgery
North Wales, Pennsylvania, 19454
University of CA Irvine Medical Center
Orange, California, 92868
Women's OB/GYN Center
Pasadena, Texas, 77505
Kaiser Permanente OB/GYN Urogynecology
San Diego, California, 92110
Scripps Clinic Carmel Valley
San Diego, California, 92130
Regional Urology, LLC
Shreveport, Louisiana, 71106
Cooper University Hospital
Voorhees Township, New Jersey, 08043
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Aurora West Allis Medical Center
West Allis, Wisconsin, 53227
Lyndhurst Clinical Research
Winston-Salem, North Carolina, 27103
About this study
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
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.
Read the detailed 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.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Uphold Lightweight Vaginal Support System, Traditional native tissue repair
- Keywords
- POP, Transvaginal, Native Tissue Repair, Repair Augmented with Mesh, Pelvic Organ Prolapse
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uphold Lightweight Vaginal Support SystemDevice
Also called Uphold LITE
Pelvic organ prolapse repair via transvaginal mesh (Uphold LITE)
Traditional native tissue repairProcedure or surgery
Sarcrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy
| Study group | Role | What they receive |
|---|---|---|
| Uphold Lightweight Vaginal Support System | Active comparator | Transvaginal repair with mesh (Uphold LITE) Receives: Device: Uphold Lightweight Vaginal Support System |
| Traditional native tissue repair | Active comparator | Sacrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy Receives: Procedure: Traditional native tissue repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: 36 months
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 36 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2013 (estimated)
- Study start10 Oct 2013
- Primary completion12 Feb 2020
- Study completion12 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 289 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karen Noblett, MD, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01917968
- Sponsor's protocol ID
- U8090
- Acronym
- Uphold LITE
- Status last verified
- Apr 2021
- First submitted
- 18 Jul 2013
- Last updated
- 20 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Kahn B, Varner RE, Murphy M, Sand P, Thomas S, Lipetskaia L, Chung DE, Mahdy A, Noblett K. Transvaginal Mesh Compared With Native Tissue Repair for Pelvic Organ Prolapse. Obstet Gynecol. 2022 Jun 1;139(6):975-985. doi: 10.1097/AOG.0000000000004794. Epub 2022 May 2.
PubMed 35675593
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01917968
- Acronym / sponsor ID
- Uphold LITE / U8090
- Conditions
- Pelvic Organ Prolapse
- Keywords
- POP, Transvaginal, Native Tissue Repair, Repair Augmented with Mesh, Pelvic Organ Prolapse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 289 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 10 Oct 2013 (actual)
- Primary completion
- 12 Feb 2020 (actual)
- Study completion
- 12 Feb 2020 (actual)
- First posted
- 7 Aug 2013 (estimated)
- Results
- Posted 15 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Uphold Lightweight Vaginal Support System | Active comparator | Device: Uphold Lightweight Vaginal Support SystemTransvaginal repair with mesh (Uphold LITE) |
| Traditional native tissue repair | Active comparator | Procedure: Traditional native tissue repairSacrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject is female
- Subject is ≥18 years of age
- 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).
- 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")
- Subject or subject's legally authorized representative must be willing to provide written informed consent
Key exclusion criteria (15 listed)
- Subject has an active or chronic systemic infection including any gynecologic infection, untreated urinary tract infection (UTI) or tissue necrosis
- Subject has history of pelvic organ cancer (e.g. uterine, ovarian, bladder, colo-rectal or cervical)
- Subject has had prior or is currently undergoing radiation, laser therapy, or chemotherapy in the pelvic area
- Subject has taken systemic steroids (within the last month) or immunosuppressive or immunomodulatory treatment (within the last 3 months)
- Subject has systemic connective tissue disease (e.g. scleroderma, systemic lupus erythematosus (SLE), Marfans syndrome, Ehlers Danlos, collagenosis, polymyositis polymyalgia rheumatica)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Uphold Lightweight Vaginal Support SystemAlso: Uphold LITEPelvic organ prolapse repair via transvaginal mesh (Uphold LITE) | Device | Uphold Lightweight Vaginal Support System |
| Traditional native tissue repairSarcrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy | Procedure or surgery | Traditional native tissue repair |
Primary outcome
Primary Efficacy Endpoint - Number of Participants With Composite Anatomic and Symptomatic Success at 36 Months
Time frame: 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).
Co-Primary Safety Endpoint - Number of Participants With One or More Serious Device-Related and/or Procedure-Related Complications at 36 Months
Time frame: 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
9 secondary outcomes
Secondary Endpoint - Number of Participants With Mesh Erosion and Exposures Over Time in Intent-to-Treat Subjects
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
Time frame: 36 Months
Secondary Endpoint - PFDI-20 Change From Baseline in Intent-to-Treat Subjects
Time frame: 6 Month, 12 Months, 18 Months, 24 Months, 36 Months
Secondary Endpoint - PFIQ-7 Change From Baseline in Intent-to-Treat Subjects
Time frame: 6 Month, 12 Months, 18 Months, 24 Months, 36 Months
Secondary Endpoint - PISQ-12 Change From Baseline in Intent-to-Treat Subjects
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
Time frame: 6 Month, 12 Months, 18 Months, 24 Months, 36 Months
Secondary Endpoint: PGI-I for Prolapse Symptoms in Intent-to-Treat Subjects
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
Time frame: 36 Months
Secondary Efficacy Endpoint - Number of Participants With Composite Anatomic and Symptomatic Success at 36 Months
Time frame: 36 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35675593Kahn B, Varner RE, Murphy M, Sand P, Thomas S, Lipetskaia L, Chung DE, Mahdy A, Noblett K. Transvaginal Mesh Compared With Native Tissue Repair for Pelvic Organ Prolapse. Obstet Gynecol. 2022 Jun 1;139(6):975-985. doi: 10.1097/AOG.0000000000004794. Epub 2022 May 2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Noblett, MD principal investigator
University of California, Irvine
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Uphold Lightweight Vaginal Support System and Traditional native tissue repair in people with Pelvic Organ Prolapse, run by Boston Scientific Corporation at 28 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Efficacy Endpoint - Number of Participants With Composite Anatomic and Symptomatic Success at 36 Months (time frame: 36 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01917968, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2021.