Pelvic Floor Muscle Training (PFMT) in Treatment and Prevention of POP (POP Study)
Condition: Uterine Prolapse; Bladder Diseases; Cystocele; Rectocele
MeSH terms: Rectocele; Cystocele; Urinary Bladder Diseases; Uterine Prolapse; Prolapse
Study type: Interventional

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.
    

Detailed description: 
      Background for the study:

      The incidences and prevalence of POP is difficult to determine, since many women do not seek
      medical advice and treatment for the condition. It has been estimated that half of women who
      have given birth lose some of the pelvic floor support, resulting in some degree of prolapse.
      Of these 10-20% will seek medical help. About 10% of all women will at one point in life
      undergo surgery for a prolapse condition. The incidence of POP requiring surgery after a
      hysterectomy is 3.6% per 1,000 women per year in the UK.

      Treatment of POP can be conservative (PFMT), mechanical (use of a pessary) or surgical. A
      recently published Cochrane review concluded that there are no studies evaluating the effect
      of PFMT on POP. PFMT is without adverse effects, and theoretical knowledge of anatomy and
      function of the PFM provides a basis for trying strength training of the PFM both to prevent
      and to reverse POP.

      In Norway Bø (1990, 1999) PhD, physiotherapist and professor at the Norwegian School of Sport
      Sciences (NSSS), has developed a training model for strengthening the PFM. The results from
      several randomised controlled trials of this program have shown high cure and improvement
      rates both in prevention and treatment of urinary incontinence.

      Ultrasound and MR examinations have shown that after vaginal delivery the pelvic floor is
      situated in a lower position than in nullipara. In addition, the pelvic floor of stress urine
      incontinent (SUI) women is in a lower position than of continent women. DeLancey et al (2003)
      showed that women with POP generated 43% less maximum force and had more atrophy of the
      pelvic floor muscles than women without prolapse. One of the main theories explaining the
      effectiveness of PFMT on SUI includes factors that may change through strength training:
      increased cross-sectional area of the muscle (muscle volume), neurogen adaptation, imposed
      viscoelastic properties ("stiffness") of the connective tissue and altered location of the
      PFM at a higher level in the pelvic cavity. Morphological changes in relation to PFMT have
      not been examined in RCTs, but have shown a cure rate of 44-70% measured as < 2 gram leakage
      in various pad tests and significant increase in muscle strength after PFMT.

      Several studies have shown that > 30% of women are unable to contract the PFM properly at the
      first consultation. Bump et al (1991) showed that 25% were pushing downwards instead of
      lifting up and in. Other common mistakes are to use muscle groups outside the pelvic area
      instead of the PFM. Instruction, feedback, close follow-up and high adherence are important
      factors if the strength training.

      Objective:

      The aim of the present study is to evaluate whether PFMT can reverse and prevent further
      development of POP. The project comprises a RCT (main study). In addition we will conduct a
      case-control study to investigate risk factors, such as muscle strength and joint flexibility
      in women with and without POP. The project description below will focus on the RCT. The same
      measurements will be used in the case-control study, and women participating in the RCT will
      be cases of the case-control study.

      Method, design:

      The main study is a prospective randomised trial. Women with POP will be referred by selected
      community gynaecologists working in Oslo and Akershus. Those who express an interest in
      participating in the project will be referred to physiotherapist and manual therapist
      Ingeborg Hoff Brækken, who is the project manager. The women will participate in a structured
      interview; complete a questionnaire about symptoms and quality of life and undergo a clinical
      examination at. Gynaecologist Majida at Akershus university hospital will conduct the
      ultrasound examination. The women will be stratified by the stage of prolapse after the
      pelvic floor prolapse quantifying (POPQ). They will then be randomised into two groups; PFMT
      or control. Brækken will train the intervention group at Hans & Olaf Fysioterapi A/S. The
      gynaecologist will be blinded for group allocation. After 6 months all women from both groups
      will be referred to the physiotherapist where they will complete the same questionnaire about
      symptoms and quality of life and measure PFM strength. The gynaecologist will then conduct
      the same ultrasound examination and POPQ.

      Drop-out routines:

      The "intention to treat" principle will be followed. Moreover, a per-protocol analysis will
      be carried out in those who have completed ≥ 80% of the recommended training regimen.

      Protocol for PFMT:

        1. Pre-contraction (the "knack"). All women will be taught how to contract the PFM before,
           during and after increases in abdominal pressure (coughing, sneezing, heavy lifting)

        2. Home training. The intervention group will be asked to perform 3 sets of 8-12 near
           maximum contractions per day in different positions with the legs abducted. All women
           will receive a booklet and a DVD showing the exercise program. Adherence will be noted
           in a diary

        3. Training and follow-up with a physiotherapist. The women visit the physiotherapist for
           training with vaginal pressure biofeedback once a week for 3 months. For the next 3
           months they train once every second week with the physiotherapist (total of 18 times).
           Muscle strength is registered at each visit.

      The control group receives no treatment. After the project period they will be referred to a
      physiotherapist if they so wish.

      Case-control study:

      In parallel with the training intervention, 50 female controls without POP will be referred
      from the same gynaecologists. In this case-control study only women with stage 0 on POPQ will
      be included in the control group. They will be examined in the same way as the main study
      group by the physiotherapist and gynaecologist. PFM strength and clinical tests for "benign
      hypermobility joint syndrome" will be conducted. They also complete the same forms as in the
      RCT.

      Statistical analysis:

      We use SPSS version 11 for data analysis with relevant statistical methods to compare the
      groups. Results of continuous variables will be given as an average of 95% CI. Results will
      be given as numbers needed to treat (NNT). The level of significance will be set at < 5%.
      Professor of statistics, Ingar Holme PhD, NSSS, is advising the project.

      Ethics

      Names and personal identity numbers will not be registered. All data will be stored in a
      locked and fireproof cabinet. Data is filed in the same way as all the project data at
      Norwegian Social Sciences Data Services (NSD) in Bergen. The project complies with the
      Helsinki declaration in requiring all participants to give their written informed consent.
      The project has been approved by the Southern Regional Health Authority's committee on
      medical ethics.
    

Intervention name(s): Pelvic floor muscle training
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: pelvic floor; exercise therapy; prevention; ultrasonography; risk factors