Follow-up Study After Manchester Operation for Pelvic Organ Prolapse

NCT02246387 | Completed

• 1 other identifier: 2013/2093/REK
• Study Type: observational
• Target: 209
• Locations: 1 country
• Sites: 1

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).

Conditions

Pelvic Organ Prolapse

Keywords

Pelvic Organ Prolapse; Gynecologic Surgery Procedures; Treatment Outcome

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Up to 7 years

Secondary Outcomes (3)

• Subjective satisfaction at the 1 and 5 year postoperative control (whole population vs subgroup with levator avulsions).

  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).

  Up to 7 years

• De novo urinary incontinence at the 1 and 5 year postoperative control (whole population vs subgroup with levator avulsions).

  Up to 7 years

Study Arms (1)

Manchester Operation

Manchester Operation: Native tissue repair

Procedure: Manchester Operation

Interventions

Manchester Operation PROCEDURE

A 3- compartment native tissue repair procedure for Pelvic Organ Prolapse.

Manchester Operation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women referred to out outpatient clinic for surgery for pelvic organ prolapse.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Gynekologisk avdeling, Oslo Universitetssykehus Ullevål

Oslo, 0424, Norway

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Sissel H Oversand, MD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

• Anne C Staff, PhD

  Oslo University Hospital; University of Oslo

  STUDY CHAIR

• Rune Svenningsen, PhD

  Oslo University Hospital; University of Oslo

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 11, 2014
• First Posted: September 22, 2014
• Study Start: October 1, 2014
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2023
• Last Updated: November 2, 2023

Record last verified: 2023-10

Locations

NO (1)