An observational study in Pelvic Organ Prolapse, sponsored by Oslo University Hospital. Completed at 1 site in Norway. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-02.
Sponsored by Oslo University Hospital · Observational
Native tissue repair for pelvic organ prolapse (POP) is the predominant surgical technique in the investigators department and the Manchester operation the preferred procedure. The investigators long-term reoperation rates for pevic organ prolapse are very low, as documented in the investigators previous long-term follow-up study (Oversand et al, International Urogynecology Journal 2013), however the data were retrospective and patients with avulsions of the levator ani muscle were not identified. The investigators hypothesize that correct fixation and elevation of the vaginal apex, as part of a three-compartment repair procedure, is essential in the POP surgical repair, also when treating women with levator ani avulsions.
The purpose of this study is to:
Many studies have shown high recurrence rates after POP surgical repair using native tissue techniques, and this led to the introduction of synthetic meshes in vaginal repair in the early 2000s. However the use of mesh has recently been put under scrutiny due to a high risk of complications, such as mesh exposure. The gran majority of the investigators patients are operated with native tissue repairs, about 60% of them by a Manchester procedure, where ligament plication is an essential part of the procedure. The investigators previous study documented high patient satisfaction and low risk of recurrence, but the data available were mainly collected retrospectively and no data were available on possible levator avulsions. Lateral defects caused by avulsions of the levator ani muscle represent a special sub-group amongst patients with POP, and are shown in several studies to have higher recurrence rates. There is no consensus on how to best repair a lateral defect in a POP, but since the prevalence of levator avulsions in patients with POP is shown to be high, the investigators find it credible that the Manchester Operation can give good results .
The main justification for this study is that the investigators already have identified a surgical technique that has documented excellent results, but studies with more detailed data quality are needed in order to better evaluate the procedure's advantages and potential disadvantages. As the use of mesh in vaginal surgery has shown unacceptable high risks of new and serious complications, there is an international focus and interest in traditional native tissue repairs and how to optimize their performance.
676 studies on the registry are indexed under Prolapse; 79 are open to participants now.
This study's enrollment of 209 is above the median of 126 across 222 observational studies indexed under Prolapse.
Browse Prolapse studies →Oslo University Hospital is the lead sponsor of 810 studies on the registry; 148 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Women referred to out outpatient clinic for surgery for pelvic organ prolapse.
Exclusion Criteria:
Manchester Operation: Native tissue repair
Procedure: Manchester Operation
A 3- compartment native tissue repair procedure for Pelvic Organ Prolapse.
Percentage with POP-Q point C equal to or less than -5 at the 1 and 5 year postoperative control compared to preoperative findings for the whole population vs subgroup with levator avulsions.
Time frame: Up to 7 years
Changes in point C and D at the 1 and 5 year postoperative control compared to preoperative findings for the whole population vs subgroup with levator avulsions.
Time frame: Up to 7 years
Subjective satisfaction at the 1 and 5 year postoperative control (whole population vs subgroup with levator avulsions).
Time frame: Up to 7 years
Changes in dyspareunia between the preoperative evaluation and at the 1 and 5 year postoperative control (whole population vs subgroup with levator avulsions).
Time frame: Up to 7 years
De novo urinary incontinence at the 1 and 5 year postoperative control (whole population vs subgroup with levator avulsions).
Time frame: Up to 7 years
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Oslo University Hospital