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Ultrasound Therapy; ComplicationsKIDSNCT06000215

Credibility of Ultrasound Detection of Female Genital Prolapse Mesh

An observational study of Ultrasound Therapy; Complications, run by Karolinska Institutet at 1 site in Sweden.

Completed

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

Official record
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Trial summary

The aim of the study is to investigate the credibility of ultrasound in detection of synthetic polypropylene vaginal implants. In detail, the study investigates if the ultrasound examiner experience and the standard method of examination may affect the detection of synthetic polypropylene vaginal implants by… Read more about this study

Who is it for?
Ages 18 to 99 years, women only
Conditions the study is for
Ultrasound Therapy; Complications
What is being tested?
Perineal/introital ultrasound examination, two different examiners. The examiners are blinded to each other and to the previous prolapse surgery. and Perineal/introital ultrasound examination, two different examiners. The examiners is now being informed of the previous prolapse surgery.
How many people
120 participants
Where
1 siteSweden
Study dates
21 Oct 2018to 21 Dec 2018
Phase
Observational
Are there results?
None posted in the registry

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 99 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients operated by one of the procedures: 1. Anterior TVM (Uphold™ Lite Vaginal mesh - Boston Scientific. 2. Posterior POP mesh (Pinnacle posterior - Boston Scientific or equal) 3. Y-shaped mesh via robotic assisted sacroclpopexy (Artisyn® Y-Shaped Mesh - Ethicon or equal). 4. patients received anterior and/or posterior colporraphy i.e. native tissue repair i.e. no synthetic materials used (control group).

Who may be able to join

  • Patients operated by one of the procedures mentioned 1. Anterior TVM (Uphold™ Lite Vaginal mesh - Boston Scientific. 2. Posterior POP mesh (Pinnacle posterior - Boston Scientific or equal) 3. Y-shaped mesh via robotic assisted sacroclpopexy (Artisyn® Y-Shaped Mesh - Ethicon or equal). and 4. patients received anterior and/or posterior colporraphy i.e. native tissue repair i.e. no synthetic materials used (control group).
  • All patients should have suffered prolapse symptoms before surgery such as pelvic heaviness and/or vaginal bulging, extra.
  • Being able to make an informed consent on participation
  • Physically and cognitively capable of participating in the examination
  • No exclusion criteria fulfilled

Who cannot join

  • Patients operated by different procedures t.ex. two different mesh types
  • Advanced procedure in the pelvic floor such as current pelvic organ cancer (regardless of treatment)
  • Other clinically relevant pelvic disorders for which surgery with other materials (not polypropylene mesh) was previously provided.

Trial locations and contacts

1 site in 1 country.

Sweden1 site
  • Division of Obstetrics and Gynecology, Department of Clinical Sciences, Karolinska Institutet Danderyd University Hospital

    Stockholm, 18288

Other trials in Sweden

About this study

The aim of the study is to investigate the credibility of ultrasound in detection of synthetic polypropylene vaginal implants. In detail, the study investigates if the ultrasound examiner experience and the standard method of examination may affect the detection of synthetic polypropylene vaginal implants by ultrasound.

The primary hypothesis is if 90% of prolapse mesh could be detected by the ultrasound examiners who are blinded to the previous prolapse surgery, the ultrasound is credible for prolapse mesh detection.

The secondary hypothesis is if the ultrasound detection is not significantly different between the ultrasound examiners, the method of ultrasound examination is mandatory to acheive credible ultrasound detection of the prolapse mesh.

Read the detailed description

Pelvic organ prolapse (POP) is a common condition in post-delivery and post-reproductive aged women (1). The lifetime risk of undergoing a single operation for prolapse or incontinence by age 80 is 11% (2). POP is mainly classified into three compartments: anterior, middle (apical) or posterior (1). Apical defects include descensus uteri or vaginal vault prolapse after previous hysterectomy. Traditional Surgical repairs of POP using native connective tissues are commonly used but the risk for POP recurrence is high if apical prolapse is present (ca 60%) (1). Thus, the development of different mesh types using different approaches to support the vaginal apex (uterus or vaginal top) is highly growing. Surgery may be done by transvaginal mesh (TVM) or robotic-assisted sacroclpopexy (3). Increasing evidence show effectivity of both methods and improved HR-QoL after surgery (4, 5, 6, 7, 8, 9). However, PFD including urinary incontinence, urinary bladder emptying disorders and prolapse recurrence may be postoperative conditions (1, 2).

Growing needs worldwide is to improve diagnostic methods such as ultrasonography (US). This may improve the clinical knowledge to be further used for management of pelvic floor disorders (PFD). US is a cheap and safe method as compared to magnetic resonance (MR) or computed tomography (CT) (10). Thus, if using US to provide clinical examination instead of MR and CT the health care cost may be reduced. Indeed, US can provide imaging in some cross sections giving same imaging results of MR (10).

Some studies have been investigating the use of endo-vaginal, trans-perineal/introital and trans-labial US techniques in detection of implants with more focus on TVT-surgery (Tension-free vaginal tape) for urinary incontinence (UI) and to some extent detection of prolapse mesh (11). However, sensitivity of depiction has been reported to 92% at rest and 72% on physical examination when using endovaginal US examination (11). Also, the depiction is dependent on the US expertise since no standardization has been achieved. Furthermore, the presence of scar tissues following previous POP or UI surgery in the pelvic floor region has been described as an interrupting factor for prediction (10).

Thus, development of a standardized US prediction of implants in order to elucidate anatomical and functional information in the pelvic floor when POP mesh is implanted may be useful in management of PFD. It is to investigate the sensitivity and reproducibility of this US model of examination.

The purpose of the present study is to investigate the credibility of the US detection of prolapse mesh implants when a standardized method of US examination is performed.

Methodology of the present study Perineal/introital and vaginal ultrasound examination is done using a standard protocol by two different US examiners of four groups of patients previously received prolapse surgery. Each examiner is to be entered from the pre-examination room, do all requested examinations in one time, and leave from the examination room to be followed by the next examiner without meeting each other. Thus, the ultrasound examiners are to be blinded to each other and to the previous prolapse surgery. A controller is appointed to introduce each examiner from the pre-examination room, record the time of each examination and collect the results of examinations. The statistician is also to be blinded to the group of examination.

References

  1. Barber MD, Maher C. Apical prolapse. Int Urogynecol J. 2013; 24(11):1815-33.
  2. Olsen AL, Smith VJ, Bergstrom JO, Colling JC, Clark AL. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol. 1997 Apr;89(4):501-6.
  3. Maher C, Feiner B, Baessler K, Schmid C. Surgical management of pelvic organ prolapse in women. Cochrane Database Syst Rev. 2013 Apr 30;(4):CD004014.
  4. Oliver JL, Kim JH. Robotic Sacrocolpopexy-Is It the Treatment of Choice for Advanced Apical Pelvic Organ Prolapse? Curr Urol Rep. 2017 Sep;18(9):66-74.
  5. Rahkola-Soisalo P, Mikkola TS, Altman D, Falconer C; for Nordic TVM Group. Pelvic Organ Prolapse Repair Using the Uphold Vaginal Support System: 5-Year Follow-up. Female Pelvic Med Reconstr Surg. 2017 Dec 11. Fortcoming 2018.
  6. Gutman RE, Rardin CR, Sokol ER, Matthews C, Park AJ, Iglesia CB, st al. Vaginal and laparoscopic mesh hysteropexy for uterovaginal prolapse: a parallel cohort study. Am J Obstet Gynecol. 2017. Jan;216(1):38.e1-38.e11.
  7. Lua LL, Vicente ED, Pathak P, Lybbert D, Dandolu V. Comparative analysis of overall cost and rate of healthcare utilization among apical prolapse procedures. Int Urogynecol J. 2017 Oct;28(10):1481-8.
  8. Rahkola-Soisalo P, Altman D, Falconer C, Morcos E, Rudnicki M, Mikkola TS. Quality of life after Uphold™ Vaginal Support System surgery for apical pelvic organ prolapse-A prospective multicenter study. Eur J Obstet Gynecol Reprod Biol. 2017 Jan;208:86-90. doi: 10.1016/j.ejogrb.2016.11.011. Epub 2016 Nov 14.
  9. Altman D, Geale K, Falconer C, Morcos E. A generic health-related quality of life instrument for assessing pelvic organ prolapse surgery: correlation with condition-specific outcome measures. Int Urogynecol J. 2018 Mar 6. doi: 10.1007/s00192-018-3587-5.
  10. Khatri G, Carmel ME, Bailey AA, Foreman MR, Brewington CC, Zimmern PE, Pedrosa I. Postoperative Imaging after Surgical Repair for Pelvic Floor Dysfunction. Radiographics. 2016 Jul-Aug;36(4):1233-56.
  11. Manonai J, Rostaminia G, Denson L, Shobeiri SA. Clinical and ultrasonographic study of patients presenting with transvaginal mesh complications. Neurourol Urodyn. 2016 Mar;35(3):407-11. doi: 10.1002/nau.22725. Epub 2015 Jan 25.
Being tested
Perineal/introital ultrasound examination, two different examiners. The examiners are blinded to each other and to the previous prolapse surgery., Perineal/introital ultrasound examination, two different examiners. The examiners is now being informed of the previous prolapse surgery.

What participants receive

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

  • Perineal/introital ultrasound examination, two different examiners. The examiners are blinded to each other and to the previous prolapse surgery.Diagnostic test

    Also called Vaginal ultrasound examination, two different examiners. The examiners are blinded to each other and to the previous prolapse surgery

    Each examiner to answer:

    1. Is there a mesh or not: Yes or No
    2. If Yes:
    • Which type of mesh? Uphold, Pinnacle Posterior or Artisyn® Y-Shaped Mesh
    • What is the length of the mesh in a single midsagittal view image
    1. Examination record time is to be registered.
  • Perineal/introital ultrasound examination, two different examiners. The examiners is now being informed of the previous prolapse surgery.Diagnostic test

    Also called Vaginal ultrasound examination, two different examiners. The examiners is now being informed of the previous prolapse surgery.

    Each examiner to answer:

    1. Is there a mesh or not: Yes or No
    2. If Yes:
    • Which type of mesh? Uphold, Pinnacle Posterior or Artisyn® Y-Shaped Mesh
    • What is the length of the mesh in a single midsagittal view image
    1. Examination record time is to be registered.
Study groups in NCT06000215
Study groupRoleWhat they receive
Uphold™ Lite Vaginal mesh - Boston Scientific (Anterior)Patients previousely received the Uphold™ Lite for the surgical management of apical and/or anterior vaginal mesh prolapse.
Receives: Diagnostic Test: Perineal/introital ultrasound examination, two different examiners. The examiners are blinded to each other and to the previous prolapse surgery.; Diagnostic Test: Perineal/introital ultrasound examination, two different examiners. The examiners is now being informed of the previous prolapse surgery.
Pinnacle posterior Vaginal mesh - Boston ScientificPatients previousely received the Pinnacle posterior Vaginal mesh for the surgical management of posterior and/or apical vaginal mesh prolapse.
Receives: Diagnostic Test: Perineal/introital ultrasound examination, two different examiners. The examiners are blinded to each other and to the previous prolapse surgery.; Diagnostic Test: Perineal/introital ultrasound examination, two different examiners. The examiners is now being informed of the previous prolapse surgery.
Artisyn® Y-Shaped Mesh (Robotic-assisted Sacral colpopexy)Patients previousely received the Artisyn® Y-Shaped Mesh via robotic-assisted approach Patients previousely received th Artisyn® Y-Shaped Mesh via robotic-assisted approach for the surgical management of apical prolapse..
Receives: Diagnostic Test: Perineal/introital ultrasound examination, two different examiners. The examiners are blinded to each other and to the previous prolapse surgery.; Diagnostic Test: Perineal/introital ultrasound examination, two different examiners. The examiners is now being informed of the previous prolapse surgery.
Native tissue repairPatients previousely received native tissue repair for the surgical management of prolapse.
Receives: Diagnostic Test: Perineal/introital ultrasound examination, two different examiners. The examiners are blinded to each other and to the previous prolapse surgery.; Diagnostic Test: Perineal/introital ultrasound examination, two different examiners. The examiners is now being informed of the previous prolapse surgery.

What is being measured

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

  1. Detection of which mesh without being informed of previous surgery

    Without being informed of previous surgery, examiners are to separately diagnose which mesh vs no mesh

    Measured: Maximum of 10 minutes for all examination

  2. Precision of mesh detection

    Being informed of which surgery, examiners are to separately measure the midsagittal lengths of the mesh.

    Measured: Maximum of 10 minutes for all examination

Timeline

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

  1. First posted21 Aug 2023
  2. Study start21 Oct 2018
  3. Primary completion21 Dec 2018
  4. Study completion21 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06000215
Sponsor's protocol ID
Dnr: 2018/1523-31
Acronym
KIDS
Status last verified
Aug 2023
First submitted
16 Feb 2023
Last updated
22 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: IPD is only available to the principal investigator.

Questions about this trial

What is this clinical trial studying?

An observational study of Ultrasound Therapy; Complications, run by Karolinska Institutet at 1 site in Sweden.

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 5 inclusion and 3 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 22 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Detection of which mesh without being informed of previous surgery (time frame: Maximum of 10 minutes for all examination). 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?
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 22 Aug 2023.

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