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

G

Glasgow Caledonian University

Status

Completed

Conditions

Pelvic Organ Prolapse

Treatments

Other: Pelvic Floor Muscle training

Study type

Interventional

Funder types

Other

Identifiers

NCT01171846
PREVPROL Study RG1271

Details and patient eligibility

About

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.

Enrollment

337 patients

Sex

Female

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

337 participants in 2 patient groups

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

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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