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

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ClinicalTrials.gov Identifier: NCT00271297
Recruitment Status : Completed
First Posted : December 30, 2005
Last Update Posted : September 21, 2009
Norwegian Foundation for Health and Rehabilitation
The Norwegian Women´s Public Health Association
Information provided by:
Norwegian School of Sport Sciences

Brief Summary:


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.


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.

Condition or disease Intervention/treatment Phase
Uterine Prolapse Bladder Diseases Cystocele Rectocele Behavioral: Pelvic floor muscle training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Effect of Pelvic Floor Muscle Training (PFMT) in Prevention and Treatment of Female Pelvic Organ Prolapse (POP).
Study Start Date : December 2005
Actual Primary Completion Date : February 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. RCT:
  2. Localisation of bladder neck, cervix and rectal ampulla at rest (translabial ultrasound)
  3. Subjective symptoms score (Mouritsen and Larsen 2003, Tegerstedt et al in press, Avery et al 2004)
  4. Ultrasound measurement of changes in muscle morphology: 1. thickness of levator ani
  5. Size of levator hiatus
  6. Levator activity during contraction, coughing and Valsava manoeuvre.
  7. Case control study:
  8. Comparison of background variables and risk factors
  9. Presence of "Benign Hypermobility Joint Syndrome"
  10. Measurement PFM strength
  11. Reproducibility study:
  12. Reproducibility of ultrasound examination of localisation and function of PFM and POP (same measurements as in the RCT)

Secondary Outcome Measures :
  1. RCT study:
  2. Independent variables (muscle function and strength)is vaginal palpation, visual observation of perineum, measurement of muscle strength with Camtech fibreoptic microtransducer connected to a vaginal balloon(Camtech AS, Sandvika, Norway)
  3. * Training diary for registration of adherence

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Pelvic organ prolapse (POP) is defined as grade 1 or more on POP-Q. This means that the most distal portion of the prolapse is less than 1 cm above the level of the hymen or that the distal edge of the cervix or vaginal cuff (post hysterectomy) is more than 2 cm lower than the total vaginal length.

Inclusion Criteria:

  • Parous women in Oslo and Akershus
  • POP grade 1-3 on POP-Q.
  • Age 18-70

Exclusion Criteria:

  • Women with POP-Q grade 0 or 4 and women with cervix elongation
  • Women with other disease: radiating back pain, neurological disorders, previous pelvic cancer, psychiatric or other disorders that have an impact on ability to train or the condition (l.o. asthma). Women who is under treatment for cancer or uses muscle relaxants
  • Previous POP surgery
  • Women who wants to use pessary/ ring during the intervention period and three weeks prior to this
  • Pregnant or nursing women, or women planning to become pregnant in the intervention period
  • Women with untreated urinary tract infection
  • Women who do not understand Norwegian
  • Woman planning to be away more than 4 weeks of the intervention period
  • Women who cannot contract the PFM

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00271297

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Norwegian School of Sport Sciences, department of Sports Medicine
Oslo, Norway, 0806
Sponsors and Collaborators
Norwegian School of Sport Sciences
Norwegian Foundation for Health and Rehabilitation
The Norwegian Women´s Public Health Association
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Study Director: Kari Bø, Prof, Dr.sci Norwegian School of Sport Sciences
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00271297    
Other Study ID Numbers: S-05146
200501371 SM/RH (NSD)
First Posted: December 30, 2005    Key Record Dates
Last Update Posted: September 21, 2009
Last Verified: September 2009
Keywords provided by Norwegian School of Sport Sciences:
pelvic floor
exercise therapy
risk factors
Additional relevant MeSH terms:
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Uterine Prolapse
Urinary Bladder Diseases
Pathological Conditions, Anatomical
Urologic Diseases
Pelvic Organ Prolapse
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Uterine Diseases