Guided imagery for women with interstitial cystitis: results of a prospective, randomized controlled pilot study.



Carrico D, Peters K, and Diokno, A. Journal of alternative and complementary medicine. 2008. Volume 14. Issue 1. Page 53 - 60.

Laura Scheufele, PT, DPT, WCS

August 5, 2015

Pelvic PT Distance Journal club

Aim: Explore the effects of guided imagery on pelvic pain and urinary symptoms in women with IC.

Design: Prospective, randomized, controlled pilot study. Authors decided that 30 subjects (15 in each arm) would adequately provide preliminary data to decide if larger-powered study would be warranted.

“Guided imagery uses words to direct one’s thoughts and attention to imagined visual, auditory, tactile, or olfactory sensations to elicit the psychologic and physiologic response of relaxation. “

Several theories for how the physiological effect is achieved with guided imagery including Gate Control Theory of pain and endorphin release.

Methodology:

Inclusion: Women at least 18 years of age and previously had IC diagnosis confirmed by cystoscopy and hydrodistension by urologist. All subjects reported urgency, and/or frequency, and pain. Levator ani muscle myalgia was confirmed with digital palpation during vaginal examination by NP. All subjects on stable medication regimen.

Exclusion: If previously participated in other clinical trials in the last 30 days or had previously had a neuromodulation device implanted in the last 90 days prior to study.

Randomization: 30 women were individually randomized by a blinded research staff member not involved in study by having participant draw a folder that included hidden notation for “Treatment group” or “Control group”.

Data Collection: Gathered at enrollment (pre-treatment) and following 8 weeks (post-treatment).

Global Response Assessment (GRA): A 7-category scale that includes responses ranging from “markedly worse” to “markedly improved.” A “moderate or marked improvement” response was needed for a subject to be classified as a “responder.”

Interstitial Cystitis Symptom Index & Problem Index (IC-SIPI): Validated tool to assess the severity and impact of IC symptoms. The IC symptom index is comprised of 4 questions with responses scored 0 to 5. The IC problem index has 4 questions that are scored from 0 to 4.

IC Self-Efficacy Scale: Tool assesses the degree of confidence that women with IC have in managing a variety of IC symptoms successfully. Each response is noted from 0 to 100 (“certain not” to “very certain”) with subscales of: Manage Pain, Fatigue, Distress, and Activity being used in study.

24-hour pain diaries: Kept twice per week, one week day and one weekend day. Recorded pain and medications.

2 day voiding diaries: Used to determine episodes of urgency and frequency, volume voided, fluid intake, and bowel frequency.

Guided Imagery/Relaxation Response Assessment: Questionnaire developed by researchers of this study. The subjects were asked how they felt overall at the end of the study as compared to the start of the study and were given a 7 point scale to respond to that ranged from “markedly worse” to “markedly improved.”

Intervention:

Intervention group subjects were issued a 25-minute guided imagery CD and asked to listen twice a day for 2 weeks.

Control group (wait-list controls) were asked to rest by sitting or laying down twice a day for 25 minutes for the 8 week time-frame.

Statistical analysis: See details in article.

Results: The two groups similar with respect to age (average 44 yo), ethnicity (all Caucasian), and educational level (93% had more than a high-school education). 57% did not work outside the home and 73% married. 5 subjects withdrew (4 from treatment group, one from control group) before completing the study for personal reasons (too busy, not able to follow protocol).

GRA: Figure 2 scores: 5/11 (45.5%) of intervention group and 2/14 (14.3%) of controls deemed responders (rating “moderate or marked improvement” of IC symptoms), however not statistically significant.

IC SIPI:  Scores declined in each group as a whole from start to finish but not statistically significant. (Table 1)

IC Self-Efficacy Scale: Both groups had improvement in scores from pre- to post tests, but not statistically significant.

24-hour 10-point VAS pain score: Figure 3. VAS score significantly reduced in treatment group from 5 to 3 (p=0.027) and reduced but not statistically significant in control group from 5 to 4 (p=0.187).

Voiding diaries: Average episodes of Urgency significantly reduced form pre- to post- intervention in treatment group (from 16 to 12; p=0.02) but no significant change in control group (p=0.684). No other significant differences noted in voids per day or night, volume voided, fluid intake, or bowel movements between groups.

Secondary analysis:

Compared those deemed “responders” on GRA and non-responders.

Ÿ Responders had significantly reduced IC-SIPI scores (problem index, p=0.006; symptom index, p=0.004).

Ÿ   Significant improvement in mean pain score from 5.50 to 2.57 vs non-responders 4.89 to 4.39.

Discussion:

Myofascial pain and pelvic floor muscle over-activity has been described in as many as 85% of patients with IC. IC is often associated with dyspareunia and flares post-coital. Pelvic floor muscle dysfunction may trigger neurogenic inflammation of the bladder wall, which increases urothelial permeability thus resulting in IC symptoms. A multidisciplinary approach can be used to address the biologic, psychosexual, psychosocial, and spiritual factors that contribute to pain.

Guided imagery is potentially another tool to assist with pelvic floor muscle relaxation, which in turn can reduce pain and symptoms. The exact mechanism of how this guided imagery helped to decrease pain and urgency remains to be seen. Although this study had a small sample size, it demonstrates a trend towards symptom reduction. Further study is warranted.

In future studies it would be beneficial to perform lab testing, brain imaging, urodynamic testing and post-treatment repeat cystoscopies. Also to further assess sexual function response as well.

Conclusion: Guided imagery MAY be a useful tool to offer women with IC for pain and urgency symptoms. It is an intervention with no negative side-effects, is readily available, and shows a trend towards reduction of IC symptoms.

Weaknesses:

No log for compliance to intervention.

No long-term follow-up.

16% drop out rate.

Although pelvic floor muscles are palpated for myalgia, no repeat testing was reported at the conclusion of the test and no measure on tone.

No post-treatment cystoscopy.

Not very structured inclusion/exclusion criteria.

Questions:

How do you improve compliance with relaxation strategies at home?

In a typical treatment when do you introduce imagery?

How does this compliment neuroscience education?

 

Resources:

Guided Imagery for Relaxation in Women with Pelvic Pain or Interstitial Cystitis. Beaumont William Beaumont Hospital. (This was the actual CD used in study)

Guided Imagery to Enhance Healing. Form Women with Pelvic Pain, Interstitial Cystitis or Vulvodynia. Beaumont William Beaumont Hospital.