Condition category
Urological and Genital Diseases
Date applied
16/03/2009
Date assigned
13/05/2009
Last edited
22/09/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Pelvic organ prolapse is bulging of one or more of the pelvic organs into the vagina. Surgery to treat pelvic organ prolapse is relatively common. Around 1 in 10 women will need prolapse surgery at some point in their lives. There is not enough evidence from research to identify which operation is best. New techniques have been introduced which use mesh to reinforce the surgery, but these have not been properly tested, especially in terms of how well they improve prolapse symptoms. In particular, there is not enough information on the effectiveness and safety of the mesh used in prolapse surgery in women.

Who can participate?
Women having a prolapse operation

What does the study involve?
Women who are having their first repair operation are randomly allocated to undergo either a standard prolapse repair, or a standard repair with a biological graft to support the stitches, or a standard repair with a mesh to support the stitches. Women who are having their second or subsequent repair are randomly allocated to undergo either a standard prolapse repair, or a standard repair with a mesh to support the stitches, or a new mesh repair using an introducer (mesh kit). This last option is only available for women having a secondary operation for prolapse as it is thought that it is more invasive than the other options, and so should be reserved for such women because they have a higher risk of failure. Women who do not wish to be randomly allocated, but are happy for their outcomes to be monitored, are examined and complete the questionnaires in the same way as the other groups. Women have a routine gynaecological examination before surgery and they complete questionnaires both before and after their operation. Further symptom questionnaires are also filled in 6, 12 and 24 months later. The women are examined and reviewed in outpatients at 4 to 6 months after surgery.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
University of Aberdeen (UK)

When is the study starting and how long is it expected to run for?
June 2009 to May 2014

Who is funding the study?
NIHR Health Technology Assessment Programme - HTA (UK)

Who is the main contact?
Dr Cathryn Glazener
c.glazener@abdn.ac.uk

Trial website

https://viis.abdn.ac.uk/HSRU/prospect/

Contact information

Type

Scientific

Primary contact

Dr Cathryn Glazener

ORCID ID

Contact details

Health Services Research Unit
University of Aberdeen
3rd Floor
Health Sciences Building
Foresterhill
Aberdeen
AB25 2ZD
United Kingdom
-
c.glazener@abdn.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 07/60/18

Study information

Scientific title

Clinical and cost-effectiveness of surgical options for the management of anterior and/or posterior vaginal wall prolapse: two randomised controlled trials within a comprehensive cohort study

Acronym

PROSPECT

Study hypothesis

Which prolapse operations are the safest and most effective and cost-effective for women with pelvic organ prolapse?

More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/076018
Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0003/51897/PRO-07-60-18.pdf

Ethics approval

The study will be submitted to the North of Scotland Research Ethics Committee in April 2009 - pending

Study design

Multi-centre randomised controlled trial and comprehensive cohort study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Vaginal wall prolapse

Intervention

All women having primary or secondary pelvic organ prolapse surgery for anterior and/or posterior vaginal wall prolapse and who consent to participate will be included in the study.

If the treating gynaecologist advises that any of the repair procedures are suitable for the patient and the woman agrees to randomisation), she will be randomised into the following arms:

For women having a primary repair:
Arm 1: Standard anterior and/or posterior repair (central plication) (reference technique)
Arm 2: Standard anterior and/or posterior repair with biological mesh inlay
Arm 3: Standard anterior and/or posterior repair with a non-absorbable or hybrid mesh inlay

In women having a secondary repair the three arms are:
Arm 1: Standard anterior and/or posterior repair (central plication) (reference technique)
Arm 2: Standard anterior and/or posterior repair with a non-absorbable or hybrid mesh inlay
Arm 3: A mesh kit (using an introducer device) with a non-absorbable or hybrid mesh

The patients who are not eligible for randomisation (if the gynaecologist advises one particular repair and/or the woman is not willing to be randomised) will be invited to consent to join the comprehensive cohort study.

All women, whether in the randomised controlled trials or the comprehensive cohort, will be followed-up in the Gynaecology Outpatients Department at around 3 to 6 months after surgery. Questionnaires will be posted to all participants at 6, 12 and 24 months after randomisation.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

1. Primary patient-reported outcome:
1.1. Symptoms of prolapse, measured as the frequency of prolapse symptoms on the Pelvic Organ Prolapse Symptom Scale (POP-SS) at two years after surgery
1.2. Quality of life (Visual Analogue Scale) outcome measured as the overall effect of prolapse symptoms on everyday life
2. Cost effectiveness: incremental cost per quality-adjusted life year (QALY) based on Euroqol EQ-5D data

All primary and secondary outcomes are measured at 6, 12 and 24 months, measured in participant-completed questionnaires.

Secondary outcome measures

1. General
1.1. Immediate and late post-operative morbidity
1.2. Other adverse effects or complications including mesh erosion or removal
1.3. Operating time
1.4. Blood loss
1.5. Number of nights in hospital
1.6. Time until resumption of usual activities
1.7. Need for further surgery for prolapse or for urinary incontinence
1.8. Time to further surgery
1.9. Satisfaction with surgery

2. Prolapse outcomes
2.1. Subjective recurrence of prolapse
2.2. Subjective continuation /recurrence of prolapse symptoms
2.3. Objective residual prolapse stage (POP-Q) at original site
2.4. Development of new (de novo) prolapse at another site
2.5. Need for other conservative prolapse treatment (e.g., pelvic floor muscle training [PFMT], mechanical device)

3. Urinary outcomes
3.1. Urinary incontinence (persistent or de novo, and types of incontinence)
3.2. Need for alternative management for incontinence (e.g., PFMT, mechanical devices, surgery, drugs, intermittent catheterisation)

4. Bowel outcomes
4.1. Constipation (persistent or de novo)
4.2. Faecal incontinence (persistent or de novo)

5. Sexual function outcomes
5.1. Dyspareunia/ apareunia/ difficulty with intercourse
5.2. Vaginal symptoms

6. Quality of life outcome measures
6.1. Condition-specific quality of life measure (e.g. physical activity, social, hygiene, sexual)
6.2. General health measures

7. Economic outcome measures
7.1. Cost and use of NHS services
7.2. Cost to the women and their families/carers
7.3. QALYs estimated from the responses to Euroqol EQ-5D
7.4. Incremental cost per QALY (QALYs based on the SF-12® Health Survey data)
7.5. The incremental costs, QALYs and incremental cost per QALY derived by the economic model

All primary and secondary outcomes are measured at 6, 12 and 24 months, measured in participant-completed questionnaires.

Overall trial start date

01/06/2009

Overall trial end date

30/04/2020

Reason abandoned

Eligibility

Participant inclusion criteria

Women (no age limits) having primary or secondary pelvic organ prolapse surgery for anterior and/or posterior vaginal wall prolapse who are willing and eligible to be randomised

Notes:
1. Women who are unwilling or ineligible for randomisation will be eligible to be followed up using the same protocol as part of the comprehensive cohort
2. Women undergoing concurrent hysterectomy/cervical amputation, vault surgery or continence procedures are also eligible

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

4,500

Participant exclusion criteria

1. Women undergoing prolapse surgery who are unwilling or unable to participate in the study
2. Women who are unable or unwilling to give competent informed consent, or are unable to complete study questionnaires

Recruitment start date

01/06/2009

Recruitment end date

31/05/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Aberdeen
Aberdeen
AB25 2ZD
United Kingdom

Sponsor information

Organisation

University of Aberdeen (UK)

Sponsor details

Research and Innovation
University Office
King's College
Aberdeen
AB24 3FX
United Kingdom

Sponsor type

University/education

Website

http://www.abdn.ac.uk/

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The first results should be published late 2016 with future publications due around one year after the overall end date.

Intention to publish date

30/04/2021

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

22/09/2016: The publication and dissemination plan has been added. 07/09/2016: The overall trial end date has been updated from 31/05/2014 to 30/04/2020. 20/04/2016: Plain English summary added.