1. To assess anatomical outcome before and after sacrospinous hysteropexy by a POP-Q and to compare with anatomical situation before surgery.2. To assess urogenital and defecatory symptoms, sexual disfunction and quality of life after sacrospinous…
ID
Source
Brief title
Condition
- Obstetric and gynaecological therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Anatomical outcome will be assessed with a POP-Q assessment and will be
compared with the POP-Q assessment before surgery.
Secondary outcome
- Quality of life after surgery will be assessed by using a standardized
general quality of life questionnaire (SF-36) and subjective outcome after
surgery by validated disease-specific Qol questionnaires (Urogenital Disease
Inventory, Defecation Distress Inventory and Incontinence Impact
Questionnaire).
- Sexual functioning after surgery will be assessed using the PISQ-12
translated in Dutch and selected items from the *Vragenlijst Seksuele
Disfuncties*.
Background summary
Among aging women, uterovaginal prolapse is a common health problem. About 40%
of parous woman have uterovaginal prolapse, and one in every 10 women will have
a uterovaginal prolapse that requires surgery. Unfortunately, the prolapse
recurs in 29% of women, with the need for a second surgical intervention.
Vaginal hysterectomy, combined with other prolapse surgery if necessary, is
currently the leading treatment in the Netherlands, for patients with
symptomatic uterovaginal prolapse. However, it has been suggested that
hysterectomy may cause an increased risk for bladder dysfunction and stress
incontinence, vaginal vault prolapse and/or enterocele and defaecatory
symptoms. Moreover, conceptually vaginal hysterectomy is not the logical first
choice in treating women with symptomatic uterovaginal prolapse, and data from
literature support this.
Many other procedures have been described, including vaginal, abdominal and
laparoscopic approaches. If one chooses a vaginal procedure to correct
uterovaginal prolapse, one can choose to retain and suspend the prolapsed
uterus rather than removing it. Women have several reasons for wanting to
preserve the uterus, such as retaining fertility and maintaining their personal
identity. Studies comparing vaginal hysterectomy (removing uterus) to
sacrospinous hysteropexy (suspending uterus), demonstrated a longer hospital
stay, more pain and longer recovery in the hysterectomy group.
Conflicting data about anatomical outcome and patient satisfaction after
sacrospinous hysteropexy have appeared in the literature. Several studies have
shown the sacrospinous hysteropexy is anatomically effective and safe and most
women are highly satisfied about the procedure. Outcome in these studies is
mainly assessed in terms of anatomical results, but there is also an evaluation
about urogenital symptoms and quality of life with validated questionnaires.
Results show that scores on all domains of urogenital symptoms and defecatory
symptoms, except for the pain and fecal incontinence domain, improved
significantly. Also, quality of life improved on all domains.
However, the only randomised controlled trial study comparing vaginal
hysterectomy and sacrospinous hysteropexy showed recurrences after one year in
27% after sacrospinous hysteropexy versus 3% after vaginal hysterectomy.
We will performe a cross-sectional study to evaluate anatomical outcome of
sarcospinous hysteropexy and to assess urogenital and defectory symptoms and
quality of life, including sexual functioning, after sacrospinous hysteropexy.
Study objective
1. To assess anatomical outcome before and after sacrospinous hysteropexy by a
POP-Q and to compare with anatomical situation before surgery.
2. To assess urogenital and defecatory symptoms, sexual disfunction and quality
of life after sacrospinous hysteropexy, in women with uterovaginal prolaps.
Study design
The proposed study concerns a cross-sectional single centre cohort study, in
Medisch Centrum Leeuwarden. This study is designed to assess quality of life,
urogenital en defecatory symptoms, sexual functioning and anatomical outcome,
in women with uterovaginal prolaps.
After inclusion, patients will receive validated questionnaires which they can
fill in at home. After that, they will come to the hospital and undergo
gynecological examination, including a POP-Q test.
Study burden and risks
-
Postbus 888
8901 BR LEEUWARDEN
NL
Postbus 888
8901 BR LEEUWARDEN
NL
Listed location countries
Age
Inclusion criteria
women who underwent a sacrospinous fixation at Medisch Centrum Leeuwarden between April 2008 and October 2009
Exclusion criteria
-
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL32941.099.10 |