NCT01171846

Brief Summary

Pelvic organ prolapse is a problem experienced by women where a bulge comes down in the vagina, and may even drop down outside the vagina. The bulge in the vagina is caused by other organs moving down from their normal position in the pelvis and pushing into the vagina. This is a very common problem and many women who have given birth will have a very mild bulge which does not cause them symptoms. Women can however experience a variety of pelvic, bladder, bowel and sexual symptoms which impact on daily life. No research studies have properly examined whether or not exercises can prevent prolapse. This study aims to explore whether exercises taught by a physiotherapist can prevent women developing a prolapse which requires them to have treatment.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
337

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2010

Longer than P75 for not_applicable

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2010

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 29, 2010

Completed
3 days until next milestone

Study Start

First participant enrolled

August 1, 2010

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

March 17, 2015

Status Verified

March 1, 2015

Enrollment Period

3.3 years

First QC Date

July 6, 2010

Last Update Submit

March 16, 2015

Conditions

Pelvic Organ Prolapse

Keywords

preventionpelvic floor muscle trainingprolapse symptomsurinary symptomssexual functionrandomised controlled trial

Outcome Measures

Primary Outcomes (5)

  • Pelvic organ prolapse symptom score (POP-SS)

    A summation of responses to seven prolapse symptom questions (range 0-28)

    Baseline (prior to randomisation)

  • Pelvic organ prolapse symptom score (POP-SS)

    A summation of responses to seven prolapse symptom questions (range 0-28)

    1 Year post randomisation

  • Pelvic organ prolapse symptom score (POP-SS)

    A summation of responses to seven prolapse symptom questions (range 0-28)

    2 years post randomisation

  • Pelvic organ prolapse symptom score (POP-SS)

    A summation of responses to seven prolapse symptom questions (range 0-28)

    3 years post randomisation

  • Pelvic organ prolapse symptom score (POP-SS)

    A summation of responses to seven prolapse symptom questions (range 0-28)

    4 years post randomisation

Secondary Outcomes (39)

  • Prolapse-related quality of life

    Baseline (prior to randomisation)

  • Prolapse severity

    Four years post randomisation

  • Lifestyle changes

    1 year post randomisation

  • Urinary symptoms

    Baseline (prior to randomisation)

  • Bowel symptoms

    Baseline (prior to randomisation)

  • +34 more secondary outcomes

Study Arms (2)

Physiotherapy

ACTIVE COMPARATOR
Other: Pelvic Floor Muscle training

Control

NO INTERVENTION

Women allocated to the Control group will only receive, by post, the same Lifestyle Advice Sheet as the intervention group.

Interventions

Pelvic Floor Muscle trainingOTHER

Women allocated to the intervention group will have five appointments with a specialist women's health physiotherapist (intervention physiotherapist) over 16 weeks who will prescribe a daily exercise programme and provide a Lifestyle Advice Sheet (focusing on weight loss, constipation, avoidance of heavy lifting, coughing and high-impact exercise) and relevant tailored advice (phase 1). Thereafter women in the intervention group will be offered Pilates-based classes, including PFMT, as maintenance (phase 2). Classes will be led by a physiotherapist who has undertaken Pilates training and will take place in six week blocks; each woman will be offered two six week blocks over a year. An exercise DVD will be provided for home use. Each woman will be offered a one-to-one review physiotherapy appointment at one and two years after randomisation.

Physiotherapy

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Women involved in the ProLong study who:
  • have some evidence of vaginal laxity in any compartment (POP-Q stage I, II or III)
  • have had no previous treatment for prolapse (surgery, pessary, PFMT)
  • Women must be willing to participate in the Trial and to comply with their group allocation.

You may not qualify if:

  • Women:
  • with stage 0 or IV prolapse
  • who have had previous incontinence surgery (except mid-urethral sling operation)
  • who have had previous formal instruction in PFMT for any diagnosis in preceding five years
  • who are pregnant, or delivered a baby within the last six months
  • who are unable to comply with PFMT treatment
  • who are unable to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Dunedin School of Medicine

Dunedin, 9054, New Zealand

Location

Aberdeen Royal Infirmary

Aberdeen, Aberdeenshire, AB25 2ZN, United Kingdom

Location

Birmingham Women's Hospital

Edgbaston, Birmingham, B15 2TG, United Kingdom

Location

Related Publications (2)

  • Hagen, S., C. Glazener, D. McClurg, C. Macarthur, P. Herbison, D. Wilson, P. Toozs-Hobson et al.

    RESULT

  • Hagen S, Glazener C, McClurg D, Macarthur C, Elders A, Herbison P, Wilson D, Toozs-Hobson P, Hemming C, Hay-Smith J, Collins M, Dickson S, Logan J. Pelvic floor muscle training for secondary prevention of pelvic organ prolapse (PREVPROL): a multicentre randomised controlled trial. Lancet. 2017 Jan 28;389(10067):393-402. doi: 10.1016/S0140-6736(16)32109-2. Epub 2016 Dec 21.

    PMID: 28010994DERIVED

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Prof Hagen, PhD MSc BSc CStat CSci

    NMAHP Research Unit

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Programme Director

Study Record Dates

First Submitted

July 6, 2010

First Posted

July 29, 2010

Study Start

August 1, 2010

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

March 17, 2015

Record last verified: 2015-03

Locations

GB(2)NZ(1)