Credibility of Ultrasound Detection of Female Genital Prolapse Mesh
Condition: Ultrasound Therapy; Complications
MeSH terms: Prolapse
Study type: Observational

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.
    

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.
    

Intervention name(s): 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.
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): 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.; 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.
Other intervention name(s): Vaginal ultrasound examination, two different examiners. The examiners are blinded to each other and to the previous prolapse surgery; Vaginal ultrasound examination, two different examiners. The examiners is now being informed of the previous prolapse surgery.
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
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).