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\title{Re: Hysteropexy in the treatment of uterine prolapse stage 2 or higher:
laparoscopic sacrohysteropexy versus sacrospinous hysteropexy---a
multicenter randomized controlled trial (LAVA trial). (First comment on
BJOG-19-1907.R1)}



\author[1]{Min Huang}%
\author[2]{Cheng-Yu Long}%
\author[3]{Zi-Xi Loo}%
\author[3]{Kun-Ling Lin}%
\affil[1]{Kuo General Hospital}%
\affil[2]{Kaohsiung Municipal Siaogang Hospital}%
\affil[3]{Kaohsiung Medical University Hospital}%


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  \date{May 05, 2024}


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\textbf{Dear Editor,~}

\textbf{}We really appreciate MN van \selectlanguage{polish}Ĳ\selectlanguage{english}sselmuiden et al. for their
efforts in conducting the first ever multicenter randomized controlled
trial to compare laparoscopic sacrohysteropexy (LSH) with sacrospinous
hysteropexy (SSHP).\textsuperscript{1} However, I have some questions
regarding the methodology and results of this trial. What are the
reasons for including patients with histories of previous pelvic floor
or prolapse surgery in the exclusion criteria? Would randomly and
equally allocating these patients into two surgical groups affect the
study result or design? Nevertheless, we are really interested in the
conduct of anterior or posterior colporrhaphy through the laparoscopic
method.

Patients presented with anterior vaginal wall prolapse are higher in
number: POP-Q stage- Aa or Ba \textgreater{} 0 (LSH group:81\%; SSHP
group:72.6\%) than those presented with apical prolapse (LSH
group:46.6\%; SSHP:45.6\%) in Table 1. The majority of study population
appears to have combined anterior and apical compartment prolapse rather
than apical prolapse alone. Furthermore, Table 2 shows that the overall
anterior compartment failure rates are 50.9\% and 56.9\% in the LSH and
SSHP groups, respectively, in a 1 year follow-up interval. The failure
rate is extraordinarily high compared with that in a previous
study.\textsuperscript{2} Hysteropexy surgery is beneficial for patients
with apical prolapse. It is not beneficial for patients with combined
anterior and apical compartment prolapse with prominent cystocele. Most
patients are satisfied with the 1 year surgical results and would
recommend surgery to someone else (LSH: 87.7\%; SSHP: 89.7\%) despite
the high recurrence rate of anterior wall prolapse in a 1 year
follow-up.

In the statistical analysis section, additional anterior vaginal wall
repairs are significantly higher in the SSHP group than those in the LSH
group (SSHP: n = 61, 98.4\%; LSH: n = 55, 85.9\%, P = 0.010). I would
like to know how this small number difference (61 - 55 = 6) in these
groups can cause significant difference in P value and how this P value
is calculated. This trial assumes a failure rate of 3\% on the basis of
the outcomes of SSHP in a previous prospective study. However, the data
population is relatively small, and the non-inferiority margin was set
at 10\%.

The primary outcome is defined as a composite outcome of the surgical
failure of the apical compartment after 12 months of follow-up and as
the recurrence of uterine prolapse (POP-Q [?] stage 2). Surgical success
is defined as the absence of prolapse beyond the hymen. In the POP-Q
stage system, POP-Q stage 2 is defined as the most distal prolapse
between 1 cm above and 1 cm beyond the hymen.\textsuperscript{3} The
most prominent prolapse, which descends beyond hymen, is the stage 2
prolapse. It elicits clinical controversy and conflicts with regard to
the definitions of surgical failure and success. We hope that this
letter will deliver the message that precise preoperative patient
selection and study design are crucial, as they may have substantial
impacts on clinical outcomes and treatment success.

Min-syuan Huang,\textsuperscript{2, 3} Zi-Xi Loo,\textsuperscript{1}Kun-
Ling Lin,\textsuperscript{1, 2} Cheng-Yu Long\textsuperscript{1, 2}

1 Department of Obstetrics and Gynecology, Kaohsiung Medical University
Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan

2 Graduate Institute of Medicine, College of Medicine, Kaohsiung Medical
University, Kaohsiung, Taiwan

3 Department of Obstetrics and Gynecology, Kuo General Hospital, Tainan,
Taiwan

\textbf{References}

\begin{enumerate}
\tightlist
\item
  van IMN, van Oudheusden A, Veen J, van de Pol G, Vollebregt A, Radder
  CM, et al. Hysteropexy in the treatment of uterine prolapse stage 2 or
  higher: laparoscopic sacrohysteropexy versus sacrospinous
  hysteropexy-a multicentre randomised controlled trial (LAVA trial).
  BJOG 2020; 127: 1284-- 1293.
\item
  Lucot JP, Cosson M, Bader G, Debodinance P, Akladios C, Salet-Liz\selectlanguage{ngerman}ée D,
  et al. Safety of Vaginal Mesh Surgery Versus Laparoscopic Mesh
  Sacropexy for Cystocele Repair: Results of the Prosthetic Pelvic Floor
  Repair Randomized Controlled Trial. \emph{European urology} .
  2018;74(2): 167-76.
\item
  Bump RC, Mattiasson A, Bo K, Brubaker LP, DeLancey JO, Klarskov P, et
  al. The standardization of terminology of female pelvic organ prolapse
  and pelvic floor dysfunction. \emph{American journal of obstetrics and
  gynecology} . 1996; 175(1):10-7.
\end{enumerate}

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