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Wednesday, November 21, 2012

Can pelvic floor muscle training reverse pelvic organ prolapse and reduce prolapse symptoms? An assessor-blinded, randomized, controlled trial.


Braekken IH, Majida M, Engh ME, Bo K. Am J Obstet Gynecol 2010;203:170e1-7.

Laura Scheufele PT, DPT, WCS
November 7, 2012

Primary Aim: To evaluate whether PFMT can (1) reverse and prevent further development of POP and (2) reduce symptoms related to POP.

Subjects: 109 women at least 1 year post-partum with POP stages I, II and III as determined by POP-Q regardless of symptoms.

Exclusion criteria as follows:  POP stage 0 or IV, inability to contract the PFM, breastfeeding, previous POP surgery, radiating back pain, pelvic cancer, neurologic disorders, psychiatric disorders, untreated urinary tract infection, planning to become pregnant during the next 6 months, or to be away for more than 4 weeks during the intervention period.
 
Study Design: An assessor-blinded, randomized, controlled, parallel group trial with stratification on severity of POP.

                Stratified into 2 groups by severity of prolapse: (1) maximal vaginal descent at or above the hymen, and (2) maximal descent below the hymen. Within each strata randomization proceeded.  

Methods:

Procedures

PFMT and control groups both advised to avoid straining and taught how to perform “the Knack”.

Controls (n=50): Asked not to start or stop PFMT during intervention period.

PFMT Group ( n=59): Advised to perform 3 sets of 8-12 close to maximum PFM contractions per day and to record home training in an exercise diary. Each subject individually supervised by a PT once a week during the first 3 months and every 2 weeks the last 3 months. Also issued a booklet and DVD showing the exercise program.

Outcome measures (assessed pre-intervention and 6 months post-test)

Stages of POP: POP-Q

Position of bladder and rectum: Standing ultrasound examination with standing technique described by Schaer et al and previously found to be reliable. The positions of the bladder and rectum quantified by locating the urethrovesical junction (bladder neck) and rectal ampulla.

Frequency and bother of prolapse symptoms: Used a previously validated scale to describe frequency (daily, weekly, monthly, or less than once per month) and 4-point scale of prolapse symptoms:  feeling of vaginal bulging and/or heaviness (none, mild, moderate, severe bother).

Frequency and bother of bladder and bowel symptoms: Same validated scale as above to describe frequency and bother of bladder symptoms (SUI, UUI) and bowel symptoms (flatus, loose, and solid FI, problems with emptying bowel). In addition, the International Consultation on Incontinence UI Short Form questionnaire (ICIQ-UI SF) used to assess UI and impact on quality of life. This is a 4 question validated incontinence screen with score of 0-21 possible.

PFM function: Evaluated by vaginal balloon catheter manometry. Strength calculated as the mean of 3 maximal voluntary contractions. Endurance defined as a sustained maximal contraction and was quantified during the first 10 seconds as the area under the curve (cmH2O sec). Pelvic floor assessment not blinded.

Results:

Stages of POP: See Table 2. Significantly more women in PFMT compared to control group improved 1 POP-Q stage (19% vs 8%).

Within the PFMT group, the number of women improving 1 stage on POP-Q increased with increasing degree of POP (0% for stage I, 16.7% stage II, 35.7% stage III).

Position of bladder and rectum: Paired ultrasound volumes (pre- and posttest) was 47 each group for position of bladder and 36 of PFMT and 38 controls for position of rectum.

The PFMT group had significantly greater cranial elevation of the bladder 2.3 mm vs -0.6 mm and rectum 4.4 mm vs -1.1 mm. The effect size calculated was 0.79 for elevation of the bladder and 0.63 for the rectum.

Frequency and bother of prolapse symptoms: See Table 3. Significant improvements with prolapse, bladder, and bowel (only flatus and loose FI) symptoms and bother for subjects who were symptomatic at baseline. After adjustment for baseline values, women in PFMT group had significantly reduced frequency (P=.015) and prolapse bother (P=.04) compared to controls. Subgroup analyses of the 40 women with prolapse below the level of hymen demonstrated a reduction in frequency of prolapse symptoms in 56% of PFMT group as compared with 15% of controls.

PFM function: PFMT group had significantly greater improvement in strength than the control group(13.1 cmH2O vs 1.1 cmH2O; P<.001) as well as endurance (107 cmH2O sec vs 8 cmH2O sec, P< .001)

Effect size for muscle strength and endurance 1.21 and 0.96 respectively.

No change in vaginal resting pressure between groups.

There were positive correlations between increased PFM strength and cranial elevation of the bladder and rectum, but no correlations between increase in PFM strength and change in POP-Q values or prolapse symptoms.

Strengths. Inclusion of stages I, II and II prolapse. Randomization. Blinding of primary outcome assessors. Use of POP-Q. Ultrasound imaging and validated questionnaires. Standardized training protocol. Low dropout rates. High adherence to training protocol.

Weaknesses: Differences between groups in prolapse symptoms at baseline: 72.9%of PFMT group vs 52% of controls (may overestimate the subjective improvement rate). Relatively small sample size. Control subjects also instructed in “the Knack”.

Conclusion: “Pelvic floor muscle training is without adverse effects and can be used as treatment for prolapse.” PFMT can help to reduce prolapse, bladder and some bowel incontinence symptoms. PFMT can significantly improve pelvic floor muscle strength, endurance, and cranial position of bladder and rectum.
 
Impact on practice: This is an important study for PT’s who treat POP. This trial provides the strongest evidence to date to support supervised PFMT as an effective treatment for POP symptoms and reduction of anatomic descent of the prolapse. Article would be excellent choice for marketing.

Food for thought:

1)     If a patient asked if pelvic exercise could reverse their prolapse, how would you respond?

2)     How does the 6 month intervention time-frame compare to your current standard of care? Does this study change how long/frequent you will treat your patients?

3)     What physiological rationale explains why there was no change in resting vaginal pressure, yet there was a significant increase in pelvic muscle strength and endurance, and the bladder and rectum were in a more elevated position following the 6 month training program?

Additional research:

Hagen S, Stark D. Conservative management of pelvic organ prolapse in women. Cochrane Database of Systematic Reviews 2011,Issue 12, Art No.:CD003882. DOI: 10.1002/14651858.CD003882.pub4.

Stupp L, Resende APM, Oliveira E, Castro RA, Girao MJBC, Sartori MGF. Pelvic floor muscle training for treatment of pelvic organ prolapse: an assessor-blinded randomized controlled trial. Int Urogynecol J. 2011;22:1233-1239. 

Braekken IH, Majida M, Engh ME, Bo K. Morphological changes after pelvic floor muscle training measured by 3-dimensional ultrasonography: A randomized controlled trial. Obstet Gynecol. 2010;115:317-24.
 
Hagen S, Stark D, Glazener C, Sinclair L, Ramsay I. A randomized controlled trial of pelvic floor muscle training for stages I and II pelvic organ prolapse. Int Urogynecol J.2009;20:45-51.
 
Ghroubi S, Kharrat O, Chaari M, Ayed B, Guermazi M, Elleuch MH. Effect of conservative treatment in the management of low-degree urogenital prolapse. Ann Readapt Med Phys. 2008;51:96-102.

Piya-Anant M, Therasakvichya S,Leelaphatanadit C,  Techatrisak K. Integrated health research program for the Thai elderly:prevalence of genital prolapse and effectiveness of pelvic floor exercise to prevent worsening of genital prolapse in elderly women. J Med Assoc Thai. 2003;86(6):509-515.

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