Skip to main content
OpenTrials
Completed

NCT Number: NCT01171846

A Study of the Effects of Physiotherapy to Prevent Pelvic Organ Prolapse

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pelvic Organ Prolapse Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapse

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dunedin School of Medicine, Dunedin, New Zealand

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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

Treatment and study plan

Pelvic Floor Muscle training

Other

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.

Primary outcomes

  1. Pelvic organ prolapse symptom score (POP-SS)

    Time frame: Baseline (prior to randomisation)

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

  2. Pelvic organ prolapse symptom score (POP-SS)

    Time frame: 1 Year post randomisation

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

  3. Pelvic organ prolapse symptom score (POP-SS)

    Time frame: 2 years post randomisation

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

  4. Pelvic organ prolapse symptom score (POP-SS)

    Time frame: 3 years post randomisation

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

  5. Pelvic organ prolapse symptom score (POP-SS)

    Time frame: 4 years post randomisation

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

Secondary outcomes

  1. Prolapse-related quality of life

    Time frame: Baseline (prior to randomisation)

    Single item scored 0 to 10

  2. Prolapse severity

    Time frame: Four years post randomisation

    Pelvic Organ Prolapse Quantification assessment

  3. Lifestyle changes

    Time frame: 1 year post randomisation

  4. Urinary symptoms

    Time frame: Baseline (prior to randomisation)

    ICIQ urinary incontinence short-form

  5. Bowel symptoms

    Time frame: Baseline (prior to randomisation)

    ICIQ bowel symptoms module

  6. Sexual symptoms

    Time frame: Baseline (prior to randomisation)

    Prolapse Incontinence Sexual Questionnaire - PISQ 12

  7. General health status

    Time frame: Baseline (prior to randomisation)

    SF-12

  8. Need for prolapse treatment

    Time frame: 1 year post randomisation

  9. The average number of days of prolapse symptoms

    Time frame: Baseline (prior to randomisation)

  10. Prolapse-related quality of life

    Time frame: 1 year post randomisation

    Single item scored 0 to 10

  11. Prolapse-related quality of life

    Time frame: 2 years post randomisation

    Single item scored 0 to 10

  12. Prolapse-related quality of life

    Time frame: 3 years post randomisation

    Single item scored 0 to 10

  13. Prolapse-related quality of life

    Time frame: 4 years post of randomisation

    Single item scored 0 to 10

  14. Lifestyle changes

    Time frame: 2 years post randomisation

  15. Lifestyle changes

    Time frame: 3 years post randomisation

  16. Lifestyle changes

    Time frame: 4 years post randomisation

  17. Urinary symptoms

    Time frame: 1 year post randomisation

    ICIQ urinary incontinence short-form

  18. Urinary symptoms

    Time frame: 2 years post randomisation

    ICIQ urinary incontinence short-form

  19. Urinary symptoms

    Time frame: 3 years post randomisation

    ICIQ urinary incontinence short-form

  20. Urinary symptoms

    Time frame: 4 years post randomisation

    ICIQ urinary incontinence short-form

  21. Bowel symptoms

    Time frame: 1 year post randomisation

    ICIQ bowel symptoms module

  22. Bowel symptoms

    Time frame: 2 years post randomisation

    ICIQ bowel symptoms module

  23. Bowel symptoms

    Time frame: 3 years post randomisation

    ICIQ bowel symptoms module

  24. Bowel symptoms

    Time frame: 4 years post randomisation

    ICIQ bowel symptoms module

  25. Sexual symptoms

    Time frame: 1 year post randomisation

    Prolapse Incontinence Sexual Questionnaire - PISQ 12

  26. Sexual symptoms

    Time frame: 2 years post randomisation

    Prolapse Incontinence Sexual Questionnaire - PISQ 12

  27. Sexual symptoms

    Time frame: 3 years post randomisation

    Prolapse Incontinence Sexual Questionnaire - PISQ 12

  28. Sexual symptoms

    Time frame: 4 years post randomisation

    Prolapse Incontinence Sexual Questionnaire - PISQ 12

  29. General health status

    Time frame: 1 year post randomisation

    Prolapse Incontinence Sexual Questionnaire - PISQ 12

  30. General health status

    Time frame: 2 years post randomisation

    Prolapse Incontinence Sexual Questionnaire - PISQ 12

  31. General health status

    Time frame: 3 years post randomisation

    Prolapse Incontinence Sexual Questionnaire - PISQ 12

  32. General health status

    Time frame: 4 years post randomisation

    Prolapse Incontinence Sexual Questionnaire - PISQ 12

  33. Need for prolapse treatment

    Time frame: 2 years post randomisation

  34. Need for prolapse treatment

    Time frame: 3 years post randomisation

  35. Need for prolapse treatment

    Time frame: 4 years post randomisation

  36. The average number of days of prolapse symptoms

    Time frame: 1 year post randomisation

  37. The average number of days of prolapse symptoms

    Time frame: 2 years post randomisation

  38. The average number of days of prolapse symptoms

    Time frame: 3 years post randomisation

  39. The average number of days of prolapse symptoms

    Time frame: 4 years post randomisation

Sponsors and collaborators

Lead sponsor

Glasgow Caledonian University

Other

Collaborators

  • Aberdeen Royal Infirmary
  • Birmingham Women's NHS Foundation Trust
  • University of Aberdeen
  • University of Birmingham
  • University of Otago

Registry information

Official study title

A Multicentre Randomised Controlled Trial of Pelvic Floor Muscle Training to Prevent Pelvic Organ Prolapse in Women

Acronym: PREVPROL

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jul 29, 2010
Registry last updated
Mar 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.