Superiority of Perineoplasty as Concomitant Surgical Procedure During Pelvic Organ Prolapse Repair

NCT05713422 | Active Not Recruiting

• 1 other identifier: NL82381.018.22
• Study Type: observational
• Target: 305
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this study is to evaluate whether adding perineoplasty is, in comparison to performing vaginal prolapse surgery without adding perineoplasty, superior with respect to efficacy and cost-effectiveness and non-inferior with respect to morbidity, in patients undergoing vaginal surgical correction of pelvic organ prolapse at 24 months after surgery.

Conditions

Pelvic Organ Prolapse

Keywords

POP; prolapse; perineoplasty

Outcome Measures

Primary Outcomes (1)

• Surgical success

  composite outcome defined as meeting the 3 following conditions: \[1\] "much improved" or "improved" in response to the patient global impression of improvement questionnaire, \[2\] no re-intervention performed in the same compartment within the first 12 months after index surgery, \[3\] no stage 2 or more POP in the operated compartment.

  12 months

Secondary Outcomes (4)

• Morbidity

  24 months

• Effectiveness

  24 months

• Anatomical outcomes

  24 months

• Societal costs

  24 months

Study Arms (2)

Operative procedure; standard treatment

Vaginal level I and/or level II repair will be performed as usual (eg anterior and/or posterior colporrhaphy, sacrospinous fixation etc.) without perineoplasty as decided by surgeon and patient. This procedure is considered as the control group.

Operative procedure; standard treatment including level III repair

Vaginal level I and/or level II repair will be performed as usual, but now including perineoplasty (level III repair) as decided by surgeon and patient. The decision of a perineoplasty to vaginal level I and/or level II repair is based on a shared decision made by surgeon together with the patient. The considerations upon which this decision has been established in a consensus meeting of Dutch urogynecologists and will be collected by a questionnaire, This group is considered as the 'intervention' group.

Eligibility Criteria

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

Study Population

Patients indicated for vaginal pelvic organ prolapse surgery.

You may qualify if:

• Female patient \>18 years of age
• Complaints of pelvic organ prolapse
• Indication for prolapse surgery (level I and/or level II repair)
• Genital hiatus (GH) according to POP-Q staging of ≥4 cm and ≤7 cm

You may not qualify if:

• Unable to understand the Dutch language
• Pregnancy at baseline or intendancy to become pregnant during the study period
• Patients with previous surgery for POP (previous mid urethral sling operations for urinary stress incontinence not excluded)
• Unwilling and / or incapable of giving informed consent

Sponsors & Collaborators

• Marjolein Spiering: lead
• Spaarne Gasthuis: collaborator

Study Sites (2)

Spaarne Gasthuis

Haarlem, Netherlands

Location

Bergman Clinics

Hilversum, 1213PA, Netherlands

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse; Prolapse

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MSc

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: February 6, 2023
• Study Start: April 23, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 5, 2024

Record last verified: 2024-08

Locations

NL (2)