Stress Urinary IncontinenceNCT03520114
Retropubic vs. Single-Incision Mid-Urethral Sling for Stress Urinary Incontinence
A study testing RP sling placement and SIS placement in people with Stress Urinary Incontinence and Pelvic Floor Disorders, run by Wake Forest University Health Sciences at 6 sites in United States.
Trial summary
One in five women will undergo prolapse surgery in their lifetime, and there is a strong correlation between prolapse and urinary incontinence. Pelvic floor surgeons aspire to improve relevant quality of life outcomes for women with pelvic floor disorders while minimizing complications and unnecessary procedures. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence, Pelvic Floor Disorders
- What is being tested?
- RP sling placement and SIS placement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 6 sitesUnited States
- Study dates
- 12 Dec 2018to 2 Jan 2024
- 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 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 21 years of age
- Women being considered for a native tissue vaginal repair in any vaginal compartment or colpocleisis
- POP ≥ stage II of any vaginal compartment, according to the pelvic organ prolapse quantification (POP-Q) system
- Vaginal bulge symptoms
- Positive standardized cough stress test on clinical examination, or on urodynamic testing
- Surgical plan that includes a native tissue vaginal repair including colpocleisis for symptomatic POP in any compartment
Show all 9Show fewer
- Understanding and acceptance of the need to return for all scheduled follow-up visits
- English speaking and able to give informed consent
- Willing and able to complete all study questionnaires
Who cannot join
- Prior surgery for stress urinary incontinence
- Status post reconstructive pelvic surgery with transvaginal mesh kits or sacrocolpopexy with synthetic mesh for prolapse
- Any serious disease, or chronic condition, that could interfere with the study compliance
- Unwilling to have a synthetic sling
- Inability to give informed consent
- Pregnancy or planning pregnancy in the first postoperative year
Show all 14Show fewer
- Untreated urinary tract infection (may be included after resolution)
- Poorly-controlled diabetes mellitus (HgbA1c > 9 within 3 months of surgery date)
- Prior pelvic radiation
- Incarcerated
- Neurogenic bladder/ pre-operative self-catheterization
- Elevated post-void residual (>150 ml) that does not resolve with prolapse reduction testing (pessary, prolapse reduced uroflow or micturition study)
- Prior augmented (synthetic mesh, autologous graft, xenograft, allograft) prolapse repair
- Planned concomitant bowel related surgery including sphincteroplasty and perineal rectal prolapse surgery, rectovaginal fistula repair, hemorrhoidectomy.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Northwestern Medical Group
Chicago, Illinois, 60611
Cleveland Clinic
Cleveland, Ohio, 44195
Northwell Health
Manhasset, New York, 11030
Women & Infants Hospital of Rhode Island
Providence, Rhode Island, 02903
MedStar Health/National Center for Advance Pelvic Surgery
Washington D.C., District of Columbia, 20010
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
Official title: Randomized Trial of Retropubic Versus Single-incision Mid-Urethral Sling (Altis ) for Concomitant Management of Stress Urinary Incontinence During Native Tissue Vaginal Repair
One in five women will undergo prolapse surgery in their lifetime, and there is a strong correlation between prolapse and urinary incontinence. Pelvic floor surgeons aspire to improve relevant quality of life outcomes for women with pelvic floor disorders while minimizing complications and unnecessary procedures. There has been an experience of disappointment and frustration when a patient returns following POP repair with new symptoms of Stress Urinary Incontinence (SUI) that she ranks as a greater disruption to her quality of life than her original vaginal bulge. While retropubic (RP) slings are considered to be the "gold-standard" referent for other slings with long-term outcomes data, they are associated with the highest risks of intra- and post-operative complications including bladder injury, bleeding, and post-operative voiding dysfunction. Single-incision slings (SIS) are the latest iteration in sling development that build upon the benefits of slings but avoid passage through the muscles of the inner thigh. The hypothesis for this study is that single-incision slings (Altis) are non-inferior to Retropubic mid-urethral slings when placed at the time of native tissue vaginal repair.
Read the detailed description
Pelvic floor surgeons aspire to improve relevant quality of life outcomes for women with pelvic floor disorders while minimizing complications and unnecessary procedures. Efficacy and risk always compete for equilibrium. Level I evidence has demonstrated a positive efficacy benefit of a concomitant synthetic mid-urethral sling in women with, and without, pre-operative symptoms of SUI who are undergoing POP repair. Concomitant sling placement has been shown to reduce the risk of de novo or persistent SUI from 50% to 23%. The combination of surgical treatment of POP and SUI at the same time, however, increases the risk of incomplete bladder emptying. While retropubic (RP) slings are considered to be the "gold-standard" referent for other slings with long-term outcomes data, they are associated with the highest risks of intra- and post-operative complications including bladder injury, bleeding, and post-operative voiding dysfunction. Single-incision slings (SIS) are the latest iteration in sling development that build upon the benefits of slings but avoid passage through the muscles of the inner thigh. As the combination of POP and sling surgery increases the risk of voiding dysfunction, and rates of incomplete bladder emptying appear significantly lower for SIS than RP slings, the study team hypothesizes that the use of the Single-incision Mid-Urethral Sling SIS will be non-inferior to RP slings in efficacy and superior in irritative voiding symptoms/voiding dysfunction at one year after combined surgery.
- Being tested
- RP sling placement, SIS placement
- Keywords
- Retropubic sling, Single-incision sling, Vaginal repair, Management
- Medical subject headings
- Urinary Incontinence, Stress, Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RP sling placementDevice
A 1.5 cm incision will be made at the mid-urethra through a separate vaginal incision with lateral dissection with Metzembaum scissors. After placement of both trocars, cystoscopy with a 70-degree scope will be performed to assess for bladder and urethral injury. Surgeons will set the tension of the tension-free vaginal tape (TVT) slings so that a spacer can be placed between the sling and the urethra. Sling tensioning will be performed after anterior and apical prolapse is corrected.
SIS placementDevice
The sling is introduced through a single anterior vaginal incision of 1.5 cm at the mid-urethra. The sling/needle assembly is advanced behind the ischiopubic rami in a transobturator trajectory toward the obturator space bilaterally. The needle is then removed by simply sliding the fixating tip back out. The other side is then completed in an identical fashion. After the fixation of the two anchors at the 2 and 10 o'clock positions, the patient's bladder is filled with 250 mL of Sodium Chloride (NaCl). Afterward, an intraoperative crede maneuver is performed and the tension adjustment suture is pulled, when necessary, to achieve the desired continence. The mesh will lie in direct apposition to the urethra. The adjustment thread is then cut short and the vaginal incision is closed with an absorbable suture.
| Study group | Role | What they receive |
|---|---|---|
| RP sling group | Experimental | Participants assigned to the retropubic (RP) sling group will have the RP sling placement procedure. Receives: Device: RP sling placement |
| SIS group | Experimental | Participants assigned to the single-incision sling (SIS) group will have the SIS placement procedure. Receives: Device: SIS placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Subjectively Bothersome Stress Incontinence
Dichotomous outcome (Yes/No), measured by a positive response of > 1 to Question 17 on Pelvic Floor Distress Inventory short form-20 (PFDI-20). Response scale from 0 to 4. Symptoms Not Present = NO 0 = not present Symptoms Present = YES, scale of bother: 1 = not at all, 2 = somewhat, 3 = moderately, 4 = quite a bit
Measured: 12 months post-operatively
Count of Participants Needing Retreatment for Stress Incontinence
This includes pelvic floor physical therapy; incontinence pessary; urethral bulking injection; repeat incontinence surgery.
Measured: 12 months post-operatively
Count of Participants With De Novo or Worsening Urge Incontinence Symptoms
Dichotomous outcome (Yes/No), measured by a worsening change in response to Question 16 on PFDI-20 with at least somewhat bothersome symptoms. Response scale from 0 to 4. Symptoms Not Present = NO 0 = not present Symptoms Present = YES, scale of bother: 1 = not at all, 2 = somewhat, 3 = moderately, 4 = quite a bit
Measured: 12 months post-operatively
Count of Participants Requiring Bladder Drainage
Beyond 2 weeks post-operatively with PVR > 150 ml OR > 1/3 total voided volume up to 12 Month post-operatively..
Measured: 12 Month post-operatively
Count of Participants Needing Surgical Intervention for Urinary Retention
Sling lysis or revision at any time point post-operatively up to 12 Month post-operatively.
Measured: 12 Month post-operatively
Secondary outcomes (2)
Number of Participants With Adverse Events
Reporting of adverse events intra- and post-operatively and include adverse events as measured by the Dindo classification system.
Measured: 12 months post-operatively
Surgeon Satisfaction Scores
Surgeon satisfaction with the sling will be assessed with a 10-point Likert Scale. The scale has a score range of 0-10, with 0=no satisfaction 10=extremely satisfied.
Measured: post-operatively up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2018
- Study start12 Dec 2018
- Primary completion2 Jan 2024
- Study completion2 Jan 2024
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 (3)Papers the sponsor has linked to this study.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for Female Health Awareness
- Responsible party
- Sponsor
- Investigators
- Catherine Matthews, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03520114
- Sponsor's protocol ID
- IRB00050256
- Status last verified
- Sep 2023
- First submitted
- 26 Apr 2018
- Last updated
- 16 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Mezes CM, Russell GB, Gutman RE, Iglesia C, Rardin C, Kenton K, Collins S, Matthews CA. Effect of Vaginal Prolapse Repair and Midurethral Sling on Urgency Incontinence Symptoms. Urogynecology (Phila). 2025 Mar 1;31(3):250-257. doi: 10.1097/SPV.0000000000001620. Epub 2024 Dec 13.
PubMed 39689213Matthews CA, Rardin CR, Sokol A, Iglesia C, Collins S, Ferrando C, Winkler H, Kenton K, Geynisman-Tan J, Gutman RE. A randomized trial of retropubic vs single-incision sling among patients undergoing vaginal prolapse repair. Am J Obstet Gynecol. 2024 Aug;231(2):261.e1-261.e10. doi: 10.1016/j.ajog.2024.04.036. Epub 2024 May 3.
PubMed 38705225Carter E, Johnson EE, Still M, Al-Assaf AS, Bryant A, Aluko P, Jeffery ST, Nambiar A. Single-incision sling operations for urinary incontinence in women. Cochrane Database Syst Rev. 2023 Oct 27;10(10):CD008709. doi: 10.1002/14651858.CD008709.pub4.
PubMed 37888839
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Retropubic Versus Single-incision Mid-Urethral Sling (Altis ) for Concomitant Management of Stress Urinary Incontinence During Native Tissue Vaginal Repair
- ClinicalTrials.gov ID
- NCT03520114
- Acronym / sponsor ID
- IRB00050256
- Keywords
- Retropubic sling, Single-incision sling, Vaginal repair, Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Foundation for Female Health Awareness
- Study start
- 12 Dec 2018 (actual)
- Primary completion
- 2 Jan 2024 (actual)
- Study completion
- 2 Jan 2024 (actual)
- First posted
- 9 May 2018 (actual)
- Results
- Posted 16 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
One in five women will undergo prolapse surgery in their lifetime, and there is a strong correlation between prolapse and urinary incontinence. Pelvic floor surgeons aspire to improve relevant quality of life outcomes for women with pelvic floor disorders while minimizing complications and unnecessary procedures. There has been an experience of disappointment and frustration when a patient returns following POP repair with new symptoms of Stress Urinary Incontinence (SUI) that she ranks as a greater disruption to her quality of life than her original vaginal bulge. While retropubic (RP) slings are considered to be the "gold-standard" referent for other slings with long-term outcomes data, they are associated with the highest risks of intra- and post-operative complications including bladder injury, bleeding, and post-operative voiding dysfunction. Single-incision slings (SIS) are the latest iteration in sling development that build upon the benefits of slings but avoid passage through the muscles of the inner thigh. The hypothesis for this study is that single-incision slings (Altis) are non-inferior to Retropubic mid-urethral slings when placed at the time of native tissue vaginal repair.
Detailed description
Pelvic floor surgeons aspire to improve relevant quality of life outcomes for women with pelvic floor disorders while minimizing complications and unnecessary procedures. Efficacy and risk always compete for equilibrium. Level I evidence has demonstrated a positive efficacy benefit of a concomitant synthetic mid-urethral sling in women with, and without, pre-operative symptoms of SUI who are undergoing POP repair. Concomitant sling placement has been shown to reduce the risk of de novo or persistent SUI from 50% to 23%. The combination of surgical treatment of POP and SUI at the same time, however, increases the risk of incomplete bladder emptying. While retropubic (RP) slings are considered to be the "gold-standard" referent for other slings with long-term outcomes data, they are associated with the highest risks of intra- and post-operative complications including bladder injury, bleeding, and post-operative voiding dysfunction. Single-incision slings (SIS) are the latest iteration in sling development that build upon the benefits of slings but avoid passage through the muscles of the inner thigh. As the combination of POP and sling surgery increases the risk of voiding dysfunction, and rates of incomplete bladder emptying appear significantly lower for SIS than RP slings, the study team hypothesizes that the use of the Single-incision Mid-Urethral Sling SIS will be non-inferior to RP slings in efficacy and superior in irritative voiding symptoms/voiding dysfunction at one year after combined surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RP sling group | Experimental | Device: RP sling placementParticipants assigned to the retropubic (RP) sling group will have the RP sling placement procedure. |
| SIS group | Experimental | Device: SIS placementParticipants assigned to the single-incision sling (SIS) group will have the SIS placement procedure. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- At least 21 years of age
- Women being considered for a native tissue vaginal repair in any vaginal compartment or colpocleisis
- POP ≥ stage II of any vaginal compartment, according to the pelvic organ prolapse quantification (POP-Q) system
- Vaginal bulge symptoms
- Positive standardized cough stress test on clinical examination, or on urodynamic testing
Key exclusion criteria (14 listed)
- Prior surgery for stress urinary incontinence
- Status post reconstructive pelvic surgery with transvaginal mesh kits or sacrocolpopexy with synthetic mesh for prolapse
- Any serious disease, or chronic condition, that could interfere with the study compliance
- Unwilling to have a synthetic sling
- Inability to give informed consent
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 |
|---|---|---|
| RP sling placementA 1.5 cm incision will be made at the mid-urethra through a separate vaginal incision with lateral dissection with Metzembaum scissors. After placement of both trocars, cystoscopy with a 70-degree scope will be performed to assess for bladder and urethral injury. Surgeons will set the tension of the tension-free vaginal tape (TVT) slings so that a spacer can be placed between the sling and the urethra. Sling tensioning will be performed after anterior and apical prolapse is corrected. | Device | RP sling group |
| SIS placementThe sling is introduced through a single anterior vaginal incision of 1.5 cm at the mid-urethra. The sling/needle assembly is advanced behind the ischiopubic rami in a transobturator trajectory toward the obturator space bilaterally. The needle is then removed by simply sliding the fixating tip back out. The other side is then completed in an identical fashion. After the fixation of the two anchors at the 2 and 10 o'clock positions, the patient's bladder is filled with 250 mL of Sodium Chloride (NaCl). Afterward, an intraoperative crede maneuver is performed and the tension adjustment suture is pulled, when necessary, to achieve the desired continence. The mesh will lie in direct apposition to the urethra. The adjustment thread is then cut short and the vaginal incision is closed with an absorbable suture. | Device | SIS group |
Primary outcome
Number of Participants With Subjectively Bothersome Stress Incontinence
Time frame: 12 months post-operatively
Dichotomous outcome (Yes/No), measured by a positive response of > 1 to Question 17 on Pelvic Floor Distress Inventory short form-20 (PFDI-20). Response scale from 0 to 4. Symptoms Not Present = NO 0 = not present Symptoms Present = YES, scale of bother: 1 = not at all, 2 = somewhat, 3 = moderately, 4 = quite a bit
Count of Participants Needing Retreatment for Stress Incontinence
Time frame: 12 months post-operatively
This includes pelvic floor physical therapy; incontinence pessary; urethral bulking injection; repeat incontinence surgery.
Count of Participants With De Novo or Worsening Urge Incontinence Symptoms
Time frame: 12 months post-operatively
Dichotomous outcome (Yes/No), measured by a worsening change in response to Question 16 on PFDI-20 with at least somewhat bothersome symptoms. Response scale from 0 to 4. Symptoms Not Present = NO 0 = not present Symptoms Present = YES, scale of bother: 1 = not at all, 2 = somewhat, 3 = moderately, 4 = quite a bit
Count of Participants Requiring Bladder Drainage
Time frame: 12 Month post-operatively
Beyond 2 weeks post-operatively with PVR > 150 ml OR > 1/3 total voided volume up to 12 Month post-operatively..
Count of Participants Needing Surgical Intervention for Urinary Retention
Time frame: 12 Month post-operatively
Sling lysis or revision at any time point post-operatively up to 12 Month post-operatively.
2 secondary outcomes
Number of Participants With Adverse Events
Time frame: 12 months post-operatively
Surgeon Satisfaction Scores
Time frame: post-operatively up to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39689213Mezes CM, Russell GB, Gutman RE, Iglesia C, Rardin C, Kenton K, Collins S, Matthews CA. Effect of Vaginal Prolapse Repair and Midurethral Sling on Urgency Incontinence Symptoms. Urogynecology (Phila). 2025 Mar 1;31(3):250-257. doi: 10.1097/SPV.0000000000001620. Epub 2024 Dec 13.
- Derived from this study: PubMed 38705225Matthews CA, Rardin CR, Sokol A, Iglesia C, Collins S, Ferrando C, Winkler H, Kenton K, Geynisman-Tan J, Gutman RE. A randomized trial of retropubic vs single-incision sling among patients undergoing vaginal prolapse repair. Am J Obstet Gynecol. 2024 Aug;231(2):261.e1-261.e10. doi: 10.1016/j.ajog.2024.04.036. Epub 2024 May 3.
- Derived from this study: PubMed 37888839Carter E, Johnson EE, Still M, Al-Assaf AS, Bryant A, Aluko P, Jeffery ST, Nambiar A. Single-incision sling operations for urinary incontinence in women. Cochrane Database Syst Rev. 2023 Oct 27;10(10):CD008709. doi: 10.1002/14651858.CD008709.pub4.
- Individual participant dataSharing planned: No
Related trials for Stress Urinary Incontinence
RecruitingPhase 3
A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight
Urinary Incontinence,Stress
Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
RecruitingPhase 1
Allogeneic Use of Expanded Mesenchymal Stem Cells Derived From Adipose Tissue (HC106), Female Urinary Incontinence Women Over 50 Years Old
Urinary Incontinence Stress
Recruiting
The Application of Somatosensory Interactive Pelvic Floor Muscle Training for Stress Urinary Incontinence in Men Underwent Radical Prostatectomy
Prostate Cancer (Post Prostatectomy)
RecruitingObservational study
Standardized 4D Transperineal Ultrasound Assessment of Urethrovesical Junction Mobility After Vaginal Laser Treatment for Stress Urinary Incontinence.
Urinary Incontinence , Stress, Laser Therapy
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.
Catherine Matthews, MD principal investigator
Wake Forest University Health Sciences
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RP sling placement and SIS placement in people with Stress Urinary Incontinence and Pelvic Floor Disorders, run by Wake Forest University Health Sciences at 6 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 9 inclusion and 14 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 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 16 Jan 2025). 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?
Number of Participants With Subjectively Bothersome Stress Incontinence (time frame: 12 months post-operatively). The study lists 5 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 NCT03520114, which also lists 3 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 16 Jan 2025.