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

• Sponsor: Glasgow Caledonian University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01171846
• Collaborator: University of Birmingham (Other), Birmingham Women's NHS Foundation Trust (Other), University of Aberdeen (Other), Aberdeen Royal Infirmary (Other), University of Otago (Other)
• Enrollment: 337
• Locations: 3
• Arms: 2
• Duration (Months): 40
• Patients Per Site: 112.3
• Patients Per Site Per Month: 2.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pelvic Organ Prolapse	Other: Pelvic Floor Muscle training	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 337 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Official Title: A Multicentre Randomised Controlled Trial of Pelvic Floor Muscle Training to Prevent Pelvic Organ Prolapse in Women
• Study Start Date: Aug 1, 2010
• Actual Primary Completion Date: Dec 1, 2013
• Actual Study Completion Date: Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Physiotherapy	Other: Pelvic Floor Muscle training; 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.
No Intervention: Control Women allocated to the Control group will only receive, by post, the same Lifestyle Advice Sheet as the intervention group.

Outcome Measures

Primary Outcome Measures

1. Pelvic organ prolapse symptom score (POP-SS) [Baseline (prior to randomisation)]

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

2. Pelvic organ prolapse symptom score (POP-SS) [1 Year post randomisation]

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

3. Pelvic organ prolapse symptom score (POP-SS) [2 years post randomisation]

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

4. Pelvic organ prolapse symptom score (POP-SS) [3 years post randomisation]

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

5. Pelvic organ prolapse symptom score (POP-SS) [4 years post randomisation]

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

Secondary Outcome Measures

1. Prolapse-related quality of life [Baseline (prior to randomisation)]

   Single item scored 0 to 10

2. Prolapse severity [Four years post randomisation]

   Pelvic Organ Prolapse Quantification assessment

3. Lifestyle changes [1 year post randomisation]

4. Urinary symptoms [Baseline (prior to randomisation)]

   ICIQ urinary incontinence short-form

5. Bowel symptoms [Baseline (prior to randomisation)]

   ICIQ bowel symptoms module

6. Sexual symptoms [Baseline (prior to randomisation)]

   Prolapse Incontinence Sexual Questionnaire - PISQ 12

7. General health status [Baseline (prior to randomisation)]

   SF-12

8. Need for prolapse treatment [1 year post randomisation]

9. The average number of days of prolapse symptoms [Baseline (prior to randomisation)]

10. Prolapse-related quality of life [1 year post randomisation]

    Single item scored 0 to 10

11. Prolapse-related quality of life [2 years post randomisation]

    Single item scored 0 to 10

12. Prolapse-related quality of life [3 years post randomisation]

    Single item scored 0 to 10

13. Prolapse-related quality of life [4 years post of randomisation]

    Single item scored 0 to 10

14. Lifestyle changes [2 years post randomisation]

15. Lifestyle changes [3 years post randomisation]

16. Lifestyle changes [4 years post randomisation]

17. Urinary symptoms [1 year post randomisation]

    ICIQ urinary incontinence short-form

18. Urinary symptoms [2 years post randomisation]

    ICIQ urinary incontinence short-form

19. Urinary symptoms [3 years post randomisation]

    ICIQ urinary incontinence short-form

20. Urinary symptoms [4 years post randomisation]

    ICIQ urinary incontinence short-form

21. Bowel symptoms [1 year post randomisation]

    ICIQ bowel symptoms module

22. Bowel symptoms [2 years post randomisation]

    ICIQ bowel symptoms module

23. Bowel symptoms [3 years post randomisation]

    ICIQ bowel symptoms module

24. Bowel symptoms [4 years post randomisation]

    ICIQ bowel symptoms module

25. Sexual symptoms [1 year post randomisation]

    Prolapse Incontinence Sexual Questionnaire - PISQ 12

26. Sexual symptoms [2 years post randomisation]

    Prolapse Incontinence Sexual Questionnaire - PISQ 12

27. Sexual symptoms [3 years post randomisation]

    Prolapse Incontinence Sexual Questionnaire - PISQ 12

28. Sexual symptoms [4 years post randomisation]

    Prolapse Incontinence Sexual Questionnaire - PISQ 12

29. General health status [1 year post randomisation]

    Prolapse Incontinence Sexual Questionnaire - PISQ 12

30. General health status [2 years post randomisation]

    Prolapse Incontinence Sexual Questionnaire - PISQ 12

31. General health status [3 years post randomisation]

    Prolapse Incontinence Sexual Questionnaire - PISQ 12

32. General health status [4 years post randomisation]

    Prolapse Incontinence Sexual Questionnaire - PISQ 12

33. Need for prolapse treatment [2 years post randomisation]

34. Need for prolapse treatment [3 years post randomisation]

35. Need for prolapse treatment [4 years post randomisation]

36. The average number of days of prolapse symptoms [1 year post randomisation]

37. The average number of days of prolapse symptoms [2 years post randomisation]

38. The average number of days of prolapse symptoms [3 years post randomisation]

39. The average number of days of prolapse symptoms [4 years post randomisation]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dunedin School of Medicine	Dunedin		New Zealand	9054
2	Aberdeen Royal Infirmary	Aberdeen	Aberdeenshire	United Kingdom	AB25 2ZN
3	Birmingham Women's Hospital	Edgbaston	Birmingham	United Kingdom	B15 2TG

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Prof Hagen, PhD MSc BSc CStat CSci, NMAHP Research Unit

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ms Suzanne Hagen, Programme Director, Glasgow Caledonian University
• ClinicalTrials.gov Identifier: NCT01171846
• Other Study ID Numbers: PREVPROL Study RG1271
• First Posted: Jul 29, 2010
• Last Update Posted: Mar 17, 2015
• Last Verified: Mar 1, 2015

• Keywords provided by Ms Suzanne Hagen, Programme Director, Glasgow Caledonian University: prevention; pelvic floor muscle training; prolapse symptoms; urinary symptoms; sexual function; randomised controlled trial
• Additional relevant MeSH terms: Prolapse; Pelvic Organ Prolapse

Study Results

No Results Posted as of Mar 17, 2015