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.
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
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
- Barber MD, Maher C. Apical prolapse. Int Urogynecol J. 2013; 24(11):1815-33.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Conditions
- Ultrasound Therapy; Complications
- 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:
- Is there a mesh or not: Yes or No
- 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
- 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:
- Is there a mesh or not: Yes or No
- 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
- Examination record time is to be registered.
| Study group | Role | What 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 Scientific | Patients 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 repair | Patients 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.
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
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.
- First posted21 Aug 2023
- Study start21 Oct 2018
- Primary completion21 Dec 2018
- Study completion21 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ultrasound Therapy; ComplicationsStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edward Morcos, Karolinska Institutet
- Investigators
- Edward Morcos, MD, PhD, Principal investigator, Karolinska Institutet - Danderyds Sjukhus (KIDS)
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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Credibility of Ultrasound Detection of Female Genital Prolapse Mesh
- ClinicalTrials.gov ID
- NCT06000215
- Acronym / sponsor ID
- KIDS / Dnr: 2018/1523-31
- Conditions
- Ultrasound Therapy; Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 21 Oct 2018 (actual)
- Primary completion
- 21 Dec 2018 (actual)
- Study completion
- 21 Dec 2018 (actual)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Barber MD, Maher C. Apical prolapse. Int Urogynecol J. 2013; 24(11):1815-33.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Uphold™ Lite Vaginal mesh - Boston Scientific (Anterior) | – | 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.Patients previousely received the Uphold™ Lite for the surgical management of apical and/or anterior vaginal mesh prolapse. |
| Pinnacle posterior Vaginal mesh - Boston Scientific | – | 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.Patients previousely received the Pinnacle posterior Vaginal mesh for the surgical management of posterior and/or apical vaginal mesh prolapse. |
| Artisyn® Y-Shaped Mesh (Robotic-assisted Sacral colpopexy) | – | 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.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.. |
| Native tissue repair | – | 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.Patients previousely received native tissue repair for the surgical management of prolapse. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- 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).
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Perineal/introital ultrasound examination, two different examiners. The examiners are blinded to each other and to the previous prolapse surgery.Also: Vaginal ultrasound examination, two different examiners. The examiners are blinded to each other and to the previous prolapse surgeryEach 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 3. Examination record time is to be registered. | Diagnostic test | Artisyn® Y-Shaped Mesh (Robotic-assisted Sacral colpopexy), Native tissue repair, Pinnacle posterior Vaginal mesh - Boston Scientific, Uphold™ Lite Vaginal mesh - Boston Scientific (Anterior) |
| Perineal/introital ultrasound examination, two different examiners. The examiners is now being informed of the previous prolapse surgery.Also: 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 3. Examination record time is to be registered. | Diagnostic test | Artisyn® Y-Shaped Mesh (Robotic-assisted Sacral colpopexy), Native tissue repair, Pinnacle posterior Vaginal mesh - Boston Scientific, Uphold™ Lite Vaginal mesh - Boston Scientific (Anterior) |
Primary outcome
Detection of which mesh without being informed of previous surgery
Time frame: Maximum of 10 minutes for all examination
Without being informed of previous surgery, examiners are to separately diagnose which mesh vs no mesh
Precision of mesh detection
Time frame: Maximum of 10 minutes for all examination
Being informed of which surgery, examiners are to separately measure the midsagittal lengths of the mesh.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
- Individual participant dataSharing planned: No. IPD is only available to the principal investigator.
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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.
Edward Morcos, MD, PhD principal investigator
Karolinska Institutet - Danderyds Sjukhus (KIDS)
1 site in 1 country: see every site and its status.
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.