Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Follow-up Study After Manchester Operation for Pelvic Organ Prolapse (MAP-POP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02246387
Recruitment Status : Completed
First Posted : September 22, 2014
Last Update Posted : April 12, 2018
Sponsor:
Information provided by (Responsible Party):
Sissel Oversand, Oslo University Hospital

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).

Condition or disease Intervention/treatment
Pelvic Organ Prolapse Procedure: Manchester Operation

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.


Layout table for study information
Study Type : Observational
Actual Enrollment : 209 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Does the Manchester Operation for Pelvic Organ Prolapse Give Sufficient Apical Fixation?
Actual Study Start Date : October 2014
Actual Primary Completion Date : January 2018
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Manchester Operation
Manchester Operation: Native tissue repair
Procedure: Manchester Operation
A 3- compartment native tissue repair procedure for Pelvic Organ Prolapse.




Primary Outcome Measures :
  1. Percentage with POP-Q point C equal to or less than -5 at the 1 year postoperative control compared to preoperative findings for the whole population vs subgroup with levator avulsions. [ Time Frame: Up to 36 months ]
  2. Changes in point C and D at the 1 year postoperative control compared to preoperative findings for the whole population vs subgroup with levator avulsions. [ Time Frame: Up to 36 months ]

Secondary Outcome Measures :
  1. Subjective satisfaction at the 1 year postoperative control (whole population vs subgroup with levator avulsions). [ Time Frame: Up to 36 months ]
  2. Changes in dyspareunia between the preoperative evaluation and at the 1 year postoperative control (whole population vs subgroup with levator avulsions). [ Time Frame: Up to 36 months ]
  3. De novo urinary incontinence at the 1 year postoperative control (whole population vs subgroup with levator avulsions). [ Time Frame: Up to 36 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women referred to out outpatient clinic for surgery for pelvic organ prolapse.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02246387


Locations
Layout table for location information
Norway
Gynekologisk avdeling, Oslo Universitetssykehus Ullevål
Oslo, Norway, 0424
Sponsors and Collaborators
Oslo University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Sissel H Oversand, MD Oslo University Hospital
Study Chair: Anne C Staff, PhD Oslo University Hospital; University of Oslo
Study Director: Rune Svenningsen, PhD Oslo University Hospital; University of Oslo

Layout table for additonal information
Responsible Party: Sissel Oversand, MD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT02246387     History of Changes
Other Study ID Numbers: 2013/2093/REK
First Posted: September 22, 2014    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018
Keywords provided by Sissel Oversand, Oslo University Hospital:
Pelvic Organ Prolapse
Gynecologic Surgery Procedures
Treatment Outcome
Additional relevant MeSH terms:
Layout table for MeSH terms
Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical