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Pelvic Floor Muscle Training (PFMT) in Treatment and Prevention of POP (POP Study)

NCT00271297 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2009-09-21

No results posted yet for this study

Summary

Background:

The pelvic floor muscles (PFM) are located inside the pelvis, surrounding the urethra, vagina and rectum. They provide structural support for the pelvic organs. Dysfunctional PFM can lead to urine and fecal incontinence, pelvic organ prolapse (POP), sexual problems and chronic pain syndromes. POP increases with age, parity and weakness in the PFM. Symptoms associated with POP are backache, bladder, bowel and sexual dysfunction, and pelvic heaviness. Thus the condition is debilitating and can greatly affect the quality of life, interfering with day-to-day activities and reduce participation in physical activity.

The aim of the project:

As life expectancy increases, more women may experience POP. Hence it is important to prevent and treat the condition at an early stage. Despite being a common disorder among women, little research has been done on POP. The aim of this study is to evaluate the effect of pelvic floor muscle training (PFMT). PFMT is a non-invasive method with no adverse effects. If there is significant effect, the main goal is to incorporate this method in clinical practice among physiotherapists and medical doctors. If PFM training is effective, more emphasis of PFM training can be put into regular female fitness programs. The prevalence of POP increases with age.

Method:

This is a single blind randomised controlled trial to evaluate the effect of PFMT on POP. 100 women with POP will be randomised to either training or control group. The training programme will last for six months, training once a week with a physiotherapist in addition to a structured home training programme. A blinded case-control study will also be carried out. 50 women without POP will be matched for age and vaginal deliveries. Before starting the RCT study, a reproducibility study on perineal ultrasound will be carried out in 18 women.

Conditions

  • Uterine Prolapse
  • Bladder Diseases
  • Cystocele
  • Rectocele

Interventions

BEHAVIORAL

Pelvic floor muscle training

Sponsors & Collaborators

  • Norwegian Foundation for Health and Rehabilitation

    collaborator OTHER

  • The Norwegian Women´s Public Health Association

    collaborator OTHER

  • Norwegian School of Sport Sciences

    lead OTHER

Principal Investigators

  • Kari Bø, Prof, Dr.sci · Norwegian School of Sport Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-12-31
Primary Completion
2009-02-28
Completion
2009-04-30

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00271297 on ClinicalTrials.gov