Clinical trial NCT02246387: Follow-up Study After Manchester Operation for Pelvic Organ Prolapse
Official title: Does the Manchester Operation for Pelvic Organ Prolapse Give Sufficient Apical Fixation?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Organ Prolapse
Keywords: Pelvic Organ Prolapse
Gynecologic Surgery Procedures
Treatment Outcome
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2014-09-22
Enrollment: 209
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women referred to out outpatient clinic for surgery for pelvic organ prolapse.

Brief summary: 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:

* prospectively evaluate if cardinal/sacrouterine ligament plication (as part of the 3-compartment Manchester procedure) gives an adequate elevation and fixation of the vaginal apex.
* assess changes in subjective symptoms between the preoperative evaluation and the 1 and 5-year postoperative evaluations.
* evaluate whether the patients identified with levator avulsions in the investigators population have an increased risk of failure (objectively and subjectively).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Women aged ≥ 18 years, understanding and reading Scandinavian or English language and being able to sign an informed consent. Non- Scandinavian speakers can be enrolled in the study as long as they understand and can communicate in English or Norwegian.
* Subjective distress from pelvic organ prolapse
* Cystocele Stage I - III with descent of the cervix Stage I-III, with or without a defect of the posterior wall (rectocele, enterocele, hypotrophic perineum).

Exclusion Criteria:

* Previous total hysterectomy (including removal of the cervix and the cardinal ligaments) or previous subtotal hysterectomy (removal of copus uteri).
* Previous surgery for POP
* Patients with a true Uterine prolapse with a descent of the corpus uteri stage II-III and not just an elongated cervix, as this group may benefit from other procedures than a Manchester operation (vaginal hysterectomy and sacrospinous fixation)
* Unable to understand patient information (in Norwegian or English) and sign an informed consent.
* Patients in whom a colpocleisis (closing of the vagina) is deemed the better surgical treatment, such as in elderly women not sexually active and not interested in future vaginal intercourse.

Primary outcomes:
measure: 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.
timeFrame: Up to 7 years
measure: 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.
timeFrame: Up to 7 years
Secondary outcomes:
measure: Subjective satisfaction at the 1 and 5 year postoperative control (whole population vs subgroup with levator avulsions).
timeFrame: Up to 7 years
measure: Changes in dyspareunia between the preoperative evaluation and at the 1 and 5 year postoperative control (whole population vs subgroup with levator avulsions).
timeFrame: Up to 7 years
measure: De novo urinary incontinence at the 1 and 5 year postoperative control (whole population vs subgroup with levator avulsions).
timeFrame: Up to 7 years
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Gynekologisk avdeling, Oslo Universitetssykehus Ullevål
Study officials:
affiliation: Oslo University Hospital
name: Sissel H Oversand, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oslo University Hospital; University of Oslo
name: Anne C Staff, PhD
role: STUDY_CHAIR
affiliation: Oslo University Hospital; University of Oslo
name: Rune Svenningsen, PhD
role: STUDY_DIRECTOR
References: