Urinary Incontinence, StressPhase 3ESTEEMNCT01959347

Combined Treatment for Mixed Incontinence

A Phase 3 study testing Miduretheral Sling and Miduretheral Sling with behavioral/pelvic floor therapy in people with Urinary Incontinence, Stress and Urinary Incontinence, Urge, run by NICHD Pelvic Floor Disorders Network at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 21 years and older, women only
Conditions the study is for: Urinary Incontinence, Stress, Urinary Incontinence, Urge
What is being tested?: Miduretheral Sling and Miduretheral Sling with behavioral/pelvic floor therapy
Type of treatment: Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 480 participants
Where: 10 sitesUnited States
Study dates: 28 Oct 2013to 29 Sep 2017
Phase: Phase 3
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 21 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Presence of both SUI and UUI on bladder diary; and > 2 IEs/3 days
> 1 Stress IE/3 day diary
> 1 Urge IE/3 day diary
Reporting at least "moderate bother" from UUI item on the UDI "Do you usually experience urine leakage associated with a feeling of urgency, that is a strong sensation of needing to go to the bathroom?"
Reporting at least "moderate bother" from SUI item on UDI "Do you usually experience urine leakage related to coughing, sneezing, or laughing"
Diagnosis of SUI defined by a positive cough stress test (CST) or urodynamic evaluation within the past 18 months

Show all 10Show fewer

Desires surgical treatment for SUI symptoms
Urinary symptoms >3 months
Subjects understand that BPTx is a treatment option for MUI outside of ESTEEM study protocol
Urodynamics within past 18 months

Who cannot join

Anterior or apical compartment prolapse at or beyond the hymen (>0 on POPQ), regardless if patient is symptomatic
a)Women with anterior or apical prolapse above the hymen (<0) who do not report vaginal bulge symptoms will be eligible
Planned concomitant surgery for anterior vaginal wall or apical prolapse > 0
a)Women undergoing only rectocele repair are eligible
Women undergoing hysterectomy for any indication will be excluded
Active pelvic organ malignancy

Show all 20Show fewer

Age <21 years
Pregnant or plans for future pregnancy in next 12 months, or within 12 months post-partum
Post-void residual >150 cc on 2 occasions, or current catheter use
Participation in other trial that may influence results of this study
Unevaluated hematuria
Prior sling, synthetic mesh for prolapse, implanted nerve stimulator for incontinence
Spinal cord injury or advanced/severe neurologic conditions including Multiple Sclerosis, Parkinsons
Women on anti-muscarinic therapy will be eligible after 3 week wash-out period
Non-ambulatory
History of serious adverse reaction to synthetic mesh
Not able to complete study assessments per clinician judgment, or not available for 12 month follow-up
Women who only report "other IE" on bladder diary, and do not report at minimum 1 stress and 1 urge IE/3 days
Diagnosis of and/or history of bladder pain or chronic pelvic pain
Women who had intravesical Botox injection within the past 12 months

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

United States10 sites

University of New Mexico Health Sciences Center, Department of Obstetrics and Gynecology
Albuquerque, New Mexico, 87131-0001
University of Alabama at Birmingham, Department of Obstetrics and Gynecology
Birmingham, Alabama, 35249-7333
Cleveland Clinic, Department OB/GYN
Cleveland, Ohio, 44195
Kaiser Permanente -- Downey
Downey, California, 90242
Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery
Durham, North Carolina, 27707
University of California at San Diego, UCSD Women's Pelvic Medicine Center
La Jolla, California, 92037-0974
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Magee-Womens Hospital, Department of Obstetrics and Gynecology
Pittsburgh, Pennsylvania, 15213
Brown/ Women and Infants Hospital of Rhode Island, Center for Women's Pelvic Medicine and Reconstructive Surgery
Providence, Rhode Island, 02903
Kaiser Permanente -- San Diego
San Diego, California, 92110

Other trials in United States

About this study

Official title: Effects of Surgical Treatment Enhanced With Exercise for Mixed Urinary Incontinence (ESTEEM)

The overarching goal of this randomized trial is to estimate the effect of combined midurethral sling (MUS) and peri-operative behavioral/pelvic floor therapy (BPTx) compared to MUS alone on successful treatment of MUI symptoms in 472 women. Secondary objectives include estimating the effect of combined treatment compared to MUS on improving overactive bladder (OAB) and stress urinary incontinence (SUI) outcomes separately, need for additional treatment, time to failure and identifying predictors of poor outcomes in this MUI population.

A supplemental study, The Human Microbiome Study of ESTEEM, will evaluate the urinary and vaginal microbiome as it relates to women with MUI, their treatment and unaffected controls.

Read the detailed description

ESTEEM is a multi-center randomized trial of 472 women with MUI who have elected to undergo surgical treatment for SUI. Participants will be randomized to a peri-operative BPTx program+MUS versus MUS alone. The purpose is to compare combined MUS+BPTx versus MUS alone (control) on improving MUI symptoms at 1 year.

Patients will be assigned to one of the two treatment groups. Randomization will be stratified by clinical site and by UUI "severity," which will be defined by the number of urgency urinary IEs on diary.

The primary outcome for this study is the mean change from baseline in UDI-total score at 1 year postoperative. The UDI is a validated, disease-specific, patient-reported outcome (PRO) measure.

Secondary outcomes UUI/OAB outcomes will be measured using the UDI-irritative subscale that measures symptom burden, impact, and changes related to OAB. It is highly responsive to treatment-related change and is able to discriminate among levels of change in all bladder diary variables (urinary urgency, frequency and urge incontinence) and patient ratings of treatment benefit that will characterize how MUS may affect all OAB symptoms individually and as a whole. SUI symptom outcomes will be measured using the UDI-stress subscale to compare SUI outcomes between women randomized to MUS + BPTx versus MUS alone.

Other UUI/OAB outcomes that will be compared between groups include 1) the change in IE frequency and type, number of urgency episodes, urgency severity with voids, number of diurnal voids, and number of nocturnal voids using a bladder diary; 2) patient satisfaction with treatment using the OAB-SAT-q; 3) bother and heal related quality of life using the OAB-q subscale

For analyzing time to failure, "failure" will be defined as initiation of any additional treatment for either SUI or UUI/OAB symptoms during the follow-up period. Subjects lost to follow up will be censored at the time of their last visit.

Quality of life/global impression will be assessed be compared between treatment groups using the a) Incontinence Impact Questionnaire (IIQ), Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ), c) European Quality of Life-5 Dimensions (EQ-5D), d) Adaptation Index and e) Patient Global Impression of Improvement (PGI-I) and Patient Global Impression of Severity (PGI-S).

Safety/additional treatments will be characterized as a) additional re-treatments for SUI or UUI within 12 months of treatment, and type of re-treatment and b) return to OR for sling revision due to worsened OAB symptoms.

To evaluate the association between PFM strength and improvements in UI symptoms, we will objectively assess PFM strength changes using the Peritron Perineometer, and instrument specifically designed for pelvic floor assessment.

Conditions: Urinary Incontinence, Stress, Urinary Incontinence, Urge
Being tested: Miduretheral Sling, Miduretheral Sling with behavioral/pelvic floor therapy
Keywords: urinary incontinence, midurethral sling, pelvic floor therapy
Medical subject headings: Urinary Incontinence, Stress, Urinary Incontinence, Urge, Urinary Incontinence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Miduretheral SlingProcedure or surgery
Also called MUS
MUS can include the TVT™ (mechanical cut mesh only, Gynecare, ETHICON Women's Health \& Urology, Somerville, NJ), TVT-O™ (mechanical cut mesh only, Gynecare), or Monarc™ (American Medical Systems, Minnetonka, MN).
Miduretheral Sling with behavioral/pelvic floor therapyOther
Also called MUS + BPTx
MUS is combined with components of behavioral therapy (designed to change behaviors to encourage continence), and pelvic floor muscle therapy (designed to strengthen the pelvic floor muscles, enhance the physiological closure of the bladder neck, and improve coordination). This is done prior to MUS (1 visit) and after MUS for 5 visits at 2, 4, 6, 8 weeks and 6 months.

Study groups in NCT01959347
Study group	Role	What they receive
Miduretheral Sling (Control)	Sham comparator	Miduretheral Sling (Control) Receives: Procedure: Miduretheral Sling
MUS+BPTx	Experimental	Miduretheral Sling with behavioral/pelvic floor therapy Receives: Other: Miduretheral Sling with behavioral/pelvic floor therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline UDI Total Score
The Urogenital Distress Inventory (UDI) is a standardized a measure of overactive bladder symptoms and health-related quality of life. The UDI scale has a range from 0 to 300 with higher scores indicating greater distress. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Measured: 3, 6, and 12 Months

Secondary outcomes (3)

Change From Baseline UDI Stress Score
The Urogenital Distress Inventory is a standardized a measure of overactive bladder symptoms and health-related quality of life. The UDI Stress subscale has a range from 0 to 100 with higher scores indicating greater distress. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Measured: 3, 6, and 12 Months
Change From Baseline UDI Irritative Score
The Urogenital Distress Inventory is a standardized a measure of overactive bladder symptoms and health-related quality of life. The UDI Irritative subscale has a range from 0 to 100 with higher scores indicating greater distress. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Measured: 3, 6, and 12 Months
Change From Baseline UDI Obstructive Score
The Urogenital Distress Inventory is a standardized a measure of overactive bladder symptoms and health-related quality of life. The UDI Obstructive subscale has a range from 0 to 100 with higher scores indicating greater distress. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Measured: 3, 6, and 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Oct 201329 Sep 2017

First posted10 Oct 2013 (estimated)
Study start28 Oct 2013
Primary completion9 Aug 2017
Study completion29 Sep 2017

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 (4)Papers the sponsor has linked to this study.
Other trials for Urinary Incontinence, StressStudies of the same condition, open and under way.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Care provider
Enrolment: 480 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01959347
Sponsor's protocol ID: PFDN-26P01
Other IDs: U10HD041261, U10HD069013, U10HD054215, U10HD041267, U10HD054214, U10HD069025, U10HD069010, U10HD041263
Acronym: ESTEEM
Status last verified: May 2020
First submitted: 8 Oct 2013
Last updated: 14 May 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

Richter HE, Carnes MU, Komesu YM, Lukacz ES, Arya L, Bradley M, Rogers RG, Sung VW, Siddiqui NY, Carper B, Mazloomdoost D, Dinwiddie D, Gantz MG; Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network. Association between the urogenital microbiome and surgical treatment response in women undergoing midurethral sling operation for mixed urinary incontinence. Am J Obstet Gynecol. 2022 Jan;226(1):93.e1-93.e15. doi: 10.1016/j.ajog.2021.07.008. Epub 2021 Jul 21.
PubMed 34297969
Sung VW, Richter HE, Moalli P, Weidner AC, Nguyen JN, Smith AL, Dunivan G, Ridgeway B, Borello-France D, Newman DK, Mazloomdoost D, Carper B, Gantz MG; NICHD Pelvic Floor Disorders Network. Characteristics Associated With Treatment Failure 1 Year After Midurethral Sling in Women With Mixed Urinary Incontinence. Obstet Gynecol. 2021 Aug 1;138(2):199-207. doi: 10.1097/AOG.0000000000004444.
PubMed 34237755
Sung VW, Richter HE, Moalli P, Weidner AC, Nguyen JN, Smith AL, Dunivan G, Ridgeway B, Borello-France D, Newman DK, Mazloomdoost D, Carper B, Gantz MG; Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network*. Characteristics Associated With Treatment Failure 1 Year After Midurethral Sling in Women With Mixed Urinary Incontinence. Obstet Gynecol. 2020 Sep;136(3):482-491. doi: 10.1097/AOG.0000000000003989.
PubMed 32769647
Sung VW, Borello-France D, Newman DK, Richter HE, Lukacz ES, Moalli P, Weidner AC, Smith AL, Dunivan G, Ridgeway B, Nguyen JN, Mazloomdoost D, Carper B, Gantz MG; NICHD Pelvic Floor Disorders Network. Effect of Behavioral and Pelvic Floor Muscle Therapy Combined With Surgery vs Surgery Alone on Incontinence Symptoms Among Women With Mixed Urinary Incontinence: The ESTEEM Randomized Clinical Trial. JAMA. 2019 Sep 17;322(11):1066-1076. doi: 10.1001/jama.2019.12467.
PubMed 31529007

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 14 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Surgical Treatment Enhanced With Exercise for Mixed Urinary Incontinence (ESTEEM)
ClinicalTrials.gov ID: NCT01959347
Acronym / sponsor ID: ESTEEM / PFDN-26P01
Conditions: Urinary Incontinence, Stress, Urinary Incontinence, Urge
Keywords: urinary incontinence, midurethral sling, pelvic floor therapy
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 480 participants (actual)
Lead sponsor: NICHD Pelvic Floor Disorders NetworkResearch network
Collaborators: Women and Infants Hospital of Rhode Island, The Cleveland Clinic, Duke University, University of Alabama at Birmingham, University of New Mexico, University of Pennsylvania, University of Pittsburgh, University of California, San Diego, Kaiser Permanente, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), RTI International
Study start: 28 Oct 2013
Primary completion: 9 Aug 2017 (actual)
Study completion: 29 Sep 2017 (actual)
First posted: 10 Oct 2013 (estimated)
Results: Posted 14 May 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A supplemental study, The Human Microbiome Study of ESTEEM, will evaluate the urinary and vaginal microbiome as it relates to women with MUI, their treatment and unaffected controls.

Detailed description

The primary outcome for this study is the mean change from baseline in UDI-total score at 1 year postoperative. The UDI is a validated, disease-specific, patient-reported outcome (PRO) measure.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (care provider)
Number of arms: 2

Arm	Type	Receives
Miduretheral Sling (Control)	Sham comparator	Procedure: Miduretheral SlingMiduretheral Sling (Control)
MUS+BPTx	Experimental	Other: Miduretheral Sling with behavioral/pelvic floor therapyMiduretheral Sling with behavioral/pelvic floor therapy

Who may qualify

Ages: 21 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Presence of both SUI and UUI on bladder diary; and > 2 IEs/3 days
Reporting at least "moderate bother" from UUI item on the UDI "Do you usually experience urine leakage associated with a feeling of urgency, that is a strong sensation of needing to go to the bathroom?"
Reporting at least "moderate bother" from SUI item on UDI "Do you usually experience urine leakage related to coughing, sneezing, or laughing"
Diagnosis of SUI defined by a positive cough stress test (CST) or urodynamic evaluation within the past 18 months
Desires surgical treatment for SUI symptoms

Key exclusion criteria (20 listed)

Anterior or apical compartment prolapse at or beyond the hymen (>0 on POPQ), regardless if patient is symptomatic
a)Women with anterior or apical prolapse above the hymen (<0) who do not report vaginal bulge symptoms will be eligible
Planned concomitant surgery for anterior vaginal wall or apical prolapse > 0
a)Women undergoing only rectocele repair are eligible
Women undergoing hysterectomy for any indication will be excluded

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
Miduretheral SlingAlso: MUSMUS can include the TVT™ (mechanical cut mesh only, Gynecare, ETHICON Women's Health \& Urology, Somerville, NJ), TVT-O™ (mechanical cut mesh only, Gynecare), or Monarc™ (American Medical Systems, Minnetonka, MN).	Procedure or surgery	Miduretheral Sling (Control)
Miduretheral Sling with behavioral/pelvic floor therapyAlso: MUS + BPTxMUS is combined with components of behavioral therapy (designed to change behaviors to encourage continence), and pelvic floor muscle therapy (designed to strengthen the pelvic floor muscles, enhance the physiological closure of the bladder neck, and improve coordination). This is done prior to MUS (1 visit) and after MUS for 5 visits at 2, 4, 6, 8 weeks and 6 months.	Other	MUS+BPTx

Primary outcome

Change From Baseline UDI Total Score
Time frame: 3, 6, and 12 Months
The Urogenital Distress Inventory (UDI) is a standardized a measure of overactive bladder symptoms and health-related quality of life. The UDI scale has a range from 0 to 300 with higher scores indicating greater distress. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

3 secondary outcomes

Change From Baseline UDI Stress Score
Time frame: 3, 6, and 12 Months
Change From Baseline UDI Irritative Score
Time frame: 3, 6, and 12 Months
Change From Baseline UDI Obstructive Score
Time frame: 3, 6, and 12 Months

Results and safety

Results posted to the registry on 14 May 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MUS Only	238	229
MUS+BPTx	242	235

Primary outcome: Change From Baseline UDI Total Score

Time frame: 3, 6, and 12 Months. Mean (95% Confidence Interval). Unit: units on a scale

Measure	MUS Only n = 229	MUS+BPTx n = 235
3 Months	-138.8 (-145.9 to -131.7)	-142.7 (-150.7 to -134.8)
6 Months	-137 (-145 to -128.9)	-147.4 (-155.4 to -139.4)
12 Months	-137.9 (-145.9 to -129.8)	-147.7 (-156.4 to -139)

Population analysed: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 Months. Other adverse events reported at 0.00% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MUS Only	28 of 238 (11.8%)	163 of 238 (68.5%)	0 of 238
MUS+BPTx	21 of 242 (8.7%)	172 of 242 (71.1%)	0 of 242

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34297969Richter HE, Carnes MU, Komesu YM, Lukacz ES, Arya L, Bradley M, Rogers RG, Sung VW, Siddiqui NY, Carper B, Mazloomdoost D, Dinwiddie D, Gantz MG; Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network. Association between the urogenital microbiome and surgical treatment response in women undergoing midurethral sling operation for mixed urinary incontinence. Am J Obstet Gynecol. 2022 Jan;226(1):93.e1-93.e15. doi: 10.1016/j.ajog.2021.07.008. Epub 2021 Jul 21.
Derived from this study: PubMed 34237755Sung VW, Richter HE, Moalli P, Weidner AC, Nguyen JN, Smith AL, Dunivan G, Ridgeway B, Borello-France D, Newman DK, Mazloomdoost D, Carper B, Gantz MG; NICHD Pelvic Floor Disorders Network. Characteristics Associated With Treatment Failure 1 Year After Midurethral Sling in Women With Mixed Urinary Incontinence. Obstet Gynecol. 2021 Aug 1;138(2):199-207. doi: 10.1097/AOG.0000000000004444.
Derived from this study: PubMed 32769647Sung VW, Richter HE, Moalli P, Weidner AC, Nguyen JN, Smith AL, Dunivan G, Ridgeway B, Borello-France D, Newman DK, Mazloomdoost D, Carper B, Gantz MG; Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network*. Characteristics Associated With Treatment Failure 1 Year After Midurethral Sling in Women With Mixed Urinary Incontinence. Obstet Gynecol. 2020 Sep;136(3):482-491. doi: 10.1097/AOG.0000000000003989.
Derived from this study: PubMed 31529007Sung VW, Borello-France D, Newman DK, Richter HE, Lukacz ES, Moalli P, Weidner AC, Smith AL, Dunivan G, Ridgeway B, Nguyen JN, Mazloomdoost D, Carper B, Gantz MG; NICHD Pelvic Floor Disorders Network. Effect of Behavioral and Pelvic Floor Muscle Therapy Combined With Surgery vs Surgery Alone on Incontinence Symptoms Among Women With Mixed Urinary Incontinence: The ESTEEM Randomized Clinical Trial. JAMA. 2019 Sep 17;322(11):1066-1076. doi: 10.1001/jama.2019.12467.
Individual participant dataSharing planned: No

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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.

Vivian W. Sung principal investigator

Brown/ Women and Infants Hospital of Rhode Island, Center for Women's Pelvic Medicine and Reconstructive Surgery

Dennis Wallace principal investigator

RTI International

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 10 inclusion and 20 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 14 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 May 2020). 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?

Change From Baseline UDI Total Score (time frame: 3, 6, and 12 Months). 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 NCT01959347, which also lists 4 linked publications.

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 14 May 2020.