Transvaginal mesh repair of recurrent vaginal prolaps (prolift technique); a cross sectional study of 65 cases in a Dutch teaching hospital.

Uterovaginal prolapse is a frequent disorder among women, especially for those
who experienced one or more vaginal births . In the Netherlands, 40% of the
women who have reached the age of 45 years or beyond have uterovaginal prolapse
. In case of 10% of these women will need a surgical approach as a remedy for
this health problem, rather than the conservative non-surgical treatment.

Historically, the most frequent way of treating women with uterovaginal
prolapse that needs surgery, is vaginal hysterectomy with, when needed,
surgical repair of any other pelvic organ prolapse. Even with various other
techniques developed over the past decades, there is still no gold standard
available . Unfortunately, recurrence of prolapse after a prior operation is
29% among these women and frequently re-operation is necessary .

One of the new techniques which have been developed in the past decades
involves the use of a nonabsorbable mesh , with the possibility to combine the
repair of anterior, posterior and apical compartment prolapse. Literature
reveals a high success rate when using this approach to correct the pelvic
floor dysfunction. However, complications are also reported. One of them is
called mesh erosion of the visceral wall and related morbidity. This is
reported to occur in 4.6-10.7% of patients. Other complications of this
procedure are perianal pain, exposure of the graft, vaginal adhesions,
infection, fistulas and dyspareunia6.
Although this procedure is widely used by gynecologists, there have been a few
randomized trials that compared mesh repair to other techniques7,9,10. Outcome
of these studies mainly reflect anatomical results. Subjective outcome is still
underexposed and are concerning quality of life, urogenital as well as
defecatory symptoms and sexual functioning .

In a cross-sectional study we will observe anatomical outcome after a procedure
using a mesh to discontinue pelvic organ prolapse. Besides these outcomes, we
will also assess subjective outcomes. These will include quality of life,
urogenital and defecatory symptoms and sexual functioning. This study will
assess the long term effects of vaginal mesh for prolapse, with minimum
follow-up of one year.

1. to measure anatomical outcome after vaginal repair with mesh (Prolift
technique) and compare with pre-operative scorings, using POP-Q test.
2. to estimate quality of life, sexual functioning, urogenital en defecatory
symptoms after vaginal repair with mesh (Prolift technique), in women with
uterovaginal prolapse.

The design of the study will be a cross-sectional study, in Medisch Centrum
Leeuwarden. The aims of this study are to assess objective outcomes and
different subjectives outcomes in women who underwent correction of
uterovaginal prolapse through vaginal repair with mesh. The patients who are
included in this study will receive questionnaires at home about quality of
life, sexual functioning, urogenital and defecatory symptoms, subjective
outcomes. Once they filled in the questionnaires, objective outcome will be
assessed by a gynecological examination in the hospital, POP-Q included.

Regulation statement
This study and its researchers will follow the principles of the Declaration of
Helsinki and those of the Medical Research Involving Human Subjects Acts (WMO).

Recruitment and consent
Patients who are eligible for this study will be approached by the research
student, who will sent them written information about the procedure and aims of
this study. When patients agree to be in this study, they receive the
questionnaires at their home address and thereby an appointment for OPD
consultation will be made for the gynecological examination.
The aim of this study is to assess anatomical and subjective outcome after
surgery, therefore interventions will not take place. As for any other
treatment decisions, these study results will not influence the outcome of it.
To obtain informed consent of all the patients individually, should be
necessary. This study proposal will be submitted by the committee of ethics of
Medisch Centrum Leeuwarden for ethical clearance.

Benefits and risk assessment
- Patients will be asked to fill in five questionnaires, this will take them
about 40 minutes on average of their time.
- Patients will visit the hospital one time to hand over their questionnaires,
when necessary discuss any indistinctiveness of the questionnaires, and undergo
gynecological examination.
- No interventions will take place during the gynecological examination.