Native Tissue Repair With Surgical Pelvic Organ Pessary - an RCT (NTRSPOP)

June 16, 2016 updated by: Dr Ivilina Pandeva, Cambridge University Hospitals NHS Foundation Trust

VAGINAL NATIVE TISSUE REPAIR AUGMENTATION WITH POST OPERATIVE PLACEMENT OF SURGICAL PELVIC ORGAN PESSARY (SPOP). A MULTICENTRE SINGLE BLINDED RANDOMISED CONTROLLED STUDY

This is an RCT looking at the primary outcome of composite success following anterior repair with native tissue at 6, 12, 24 months in two arms. One arm will be randomised to have a soft silicone pessary inserted into the vagina post operatively for three weeks and the other will not.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Prolapse of the vagina is a common problem for women and varies from mildly bothersome to very problematic. About one in ten women in the developed world will require surgery for prolapse in their lifetime. The results of surgery are not perfect and some of women will develop prolapse again or not be satisfied with the result.

In this study a soft silicone support (SPOP) is inserted into the vagina straight after prolapse surgery. Women who have agreed to the study will be randomly chosen to have the SPOP at the time of surgery. There will be 120 patients in the study; so 60 women will have the SPOP inserted.

The investigators think that SPOP will support the vagina as it heals, improving the results of surgery. There are already some studies of the SPOP with other surgeries that show improved results. The SPOP is inserted while the patient is sleeping and is removed four weeks after surgery. It is attached with two dissolving stiches to the vagina. After four weeks is will be removed in the out patient clinic without any discomfort. It is not usually painful or uncomfortable at any time.

The actual surgery the women have will not be any different had they not been in the study. All the women in the study will have the normal assessment prior to their operation, and will fill out some questionnaires about their symptoms too. All women involved in the study will come back the clinic to be seen after six months, one year and two years from the date of the surgery. This is regardless of whether they had the SPOP or not. When the women return they will be examined and complete the questionnaires again each visit.

The results of the study will be reported and published.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom
        • Department of Urogynaecology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women with symptomatic pelvic organ prolapse requiring an anterior vaginal repair at the study centre.
  • Currently on the hospital waiting list for vaginal native tissue repair
  • Willingness to participate
  • Medically fit for surgery
  • 18 years or over
  • Reasonable level of English to complete questionnaires
  • Patients have not been recommended surgery that involves colpocliesis, mesh, or laparoscopic approach

Exclusion Criteria:

  • Asymptomatic pelvic organ prolapse
  • Refusal to participate
  • Medically unfit for surgery
  • Under 18
  • Unable to complete questionnaires due to poor level of english
  • Patients has been recommended surgery that involves colpocliesis, mesh, or laparoscopic approach

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: SPOP
This arm will have the soft silicone pessary inserted post operatively and it will remain in-situ for 3 weeks.
Other: Surgical Pelvic Organ Pessary
In participants randomized to intervention, the SPOP will be placed at the completion of surgery, following routine placement of IDC and prior to placement of vaginal pack. The SPOP is available in 4 sizes and the surgeon will select the appropriate size so that the SPOP rests snugly without undue tension inside the hymeneal remnant. The SPOP is sutured in place with 2/0 Vicryl to prevent dislodgement at the level of the hymen.
No Intervention: Non Intervention
Routine post operative care

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Success in anterior compartment.
Time Frame: 6 months post operative

Success defined as composite of success based on objective findings and subjective patient report.

Objective anatomic success as Anterior Prolapse no greater than Stage 1 (reference point Ba <-1cm) on validated POPQ examination. Subjective success as defined as absence of 'bulge' symptom on PDFI-20 validated questionnaire.

Failure will be defined as leading edge of anterior vaginal wall a Stage 2 or more (reference point Ba =>-1cm), or presence of 'vaginal bulge' symptom on validated questionnaire.
6 months post operative
Success in Anterior Compartment
Time Frame: 12 months post operative

Success defined as composite of success based on objective findings and subjective patient report.

Objective anatomic success as Anterior Prolapse no greater than Stage 1 (reference point Ba <-1cm) on validated POPQ examination. Subjective success as defined as absence of 'bulge' symptom on PDFI-20 validated questionnaire.

Failure will be defined as leading edge of anterior vaginal wall a Stage 2 or more (reference point Ba =>-1cm), or presence of 'vaginal bulge' symptom on validated questionnaire.
12 months post operative
Success in Anterior Compartment
Time Frame: 24months post operative

Success defined as composite of success based on objective findings and subjective patient report.

Objective anatomic success as Anterior Prolapse no greater than Stage 1 (reference point Ba <-1cm) on validated POPQ examination. Subjective success as defined as absence of 'bulge' symptom on PDFI-20 validated questionnaire.

Failure will be defined as leading edge of anterior vaginal wall a Stage 2 or more (reference point Ba =>-1cm), or presence of 'vaginal bulge' symptom on validated questionnaire.
24months post operative

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in POP-Q quantitative measurements from baseline
Time Frame: 6 months
6 months
Change in POP-Q quantitative measurements from baseline
Time Frame: 12 months
12 months
Change in POP-Q quantitative measurements from baseline
Time Frame: 24 months
24 months
Division of vaginal band
Time Frame: 6months
Any patient requiring repeat procedure for division vaginal band with in 6 months post operative.
6months
Anatomic success of any associated posterior repair procedure
Time Frame: 24 months post operative
Objective anatomic success as Posterior Prolapse no greater than Stage 1 (reference point Bp <-1cm) on validated POPQ examination.
24 months post operative
Anatomic success of any associated posterior repair procedure
Time Frame: 6 months
Objective anatomic success as Posterior Prolapse no greater than Stage 1 (reference point Bp <-1cm) on validated POPQ examination.
6 months
Anatomic success of any associated posterior repair procedure
Time Frame: 12 months
Objective anatomic success as Posterior Prolapse no greater than Stage 1 (reference point Bp <-1cm) on validated POPQ examination.
12 months
Anatomic success of any associated apical repair procedure
Time Frame: 6 months
Objective anatomic success as apical prolapse no greater than Stage 1 (reference point C <-1cm) on validated POPQ examination.
6 months
Anatomic success of any associated apical repair procedure
Time Frame: 12 months
Objective anatomic success as apical prolapse no greater than Stage 1 (reference point C <-1cm) on validated POPQ examination.
12 months
Anatomic success of any associated apical repair procedure
Time Frame: 24 months
Objective anatomic success as apical prolapse no greater than Stage 1 (reference point C <-1cm) on validated POPQ examination.
24 months
Five point Patient Global Assessment of Change (PGA-C) visual analogue scale 6 months following surgery
Time Frame: 6 months
6 months
Five point Patient Global Assessment of Change (PGA-C) visual analogue scale 6 months following surgery
Time Frame: 12 months
12 months
Five point Patient Global Assessment of Change (PGA-C) visual analogue scale 6 months following surgery
Time Frame: 24months
24months
Change in PISQ-IR
Time Frame: 6 months
Validated patient reported outcome - pelvic organ prolapse incontinence questionnaire IUGA revised
6 months
Change in PISQ-IR
Time Frame: 12 months
Validated patient reported outcome - pelvic organ prolapse incontinence questionnaire IUGA revised
12 months
Change in PISQ-IR
Time Frame: 24 months
Validated patient reported outcome - pelvic organ prolapse incontinence questionnaire IUGA revised
24 months
Change in PFDI - 20
Time Frame: 24 months
Validated patient reported outcome (pelvic floor distress inventory) -
24 months
Change in PFDI-20
Time Frame: 12 months
Validated patient reported outcome (pelvic floor distress inventory) -
12 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Complications of surgery as per the Clavien-Dindo classification system
Time Frame: Peri operative
Peri operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cambridge University Hospitals NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 7, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 21, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 21, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A094029

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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