Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06000215 |
| Other study ID # |
Dnr: 2018/1523-31 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 21, 2018 |
| Est. completion date |
December 21, 2018 |
Study information
| Verified date |
August 2023 |
| Source |
Karolinska Institutet |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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 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.
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.
