Pelvic Health: Terminology and Language

Pelvic Health Language

• Working in pelvic health involves handling intimate and sensitive client stories with reverence and respect.
• Language, both spoken and body language, is crucial in this field.
• Client's choice of words may differ significantly; respect their terminology.
• Pay close attention to their communication style, including word choice, body language, eye contact, hesitations, and unspoken cues when dealing with difficult topics.
• In the context of gender, "female/woman" refers to individuals with a vagina and female anatomy, while "male/man" indicates those with a penis and male anatomy.
• The information primarily addresses issues in teenagers and adults, excluding conditions experienced by children.

Pelvic Health Terminology

Pregnancy Related

• Number of weeks pregnant is written as… /40 e.g. 12 weeks pregnant is 12/40
• GPL means Gravida/Parity/Living
• Gravida: Number of times pregnant.
• Parity: Number of births reaching 20 weeks (live births and stillbirths).
• Living: Number of live babies delivered.
• Nulligravida/nullip/nulliparous: Never been pregnant.
• Primigravida/primip/primiparous: Pregnant for the first time or once.
• Multigravida/multip/multiparous: More than one pregnancy.
• LUSCS: Lower uterine segment Cesarean section.
• NVD: Normal vaginal delivery.
• VD: Vaginal delivery.
• PN: Post-natal.

Anatomical Related

• LAD: Levator avulsion defect.
• GH: Genital hiatus.
• LH: Levator hiatus.
• POP: Pelvic organ prolapse.
• PB: Perineal body.
• TVL: Total vaginal length.
• PFM: Pelvic floor muscles.
• PFMT: Pelvic floor muscle training.
• IC: Iliococcygeus.
• PC: Pubococcygeus.
• PR: Puborectalis (also for per rectal examination).
• EAS: External anal sphincter.
• IAS: Internal anal sphincter.
• TA: Transverse abdominus.

Other

• DPV: Digital per vaginal examination.
• VE: Vaginal examination.
• DPR: Digital per rectal examination.
• ED: Erectile dysfunction.
• HRT: Hormone replacement therapy.
• Sx: Symptoms OR surgery.
• UI: Urinary incontinence.
• UUI: Urge urinary incontinence.
• SUI: Stress urinary incontinence.
• MUI: Mixed urinary incontinence.
• FI: Fecal incontinence.
• PH: Past history.
• PC: Presenting condition.

Pelvic Anatomy

• Understanding the bony and soft tissue anatomy of the pelvis is fundamental for treating musculoskeletal conditions of the pelvic region and sexual dysfunction.

Bony Pelvis and Associated Soft Tissue Structures

• The pelvic girdle connects the lower limb to the axial skeleton.
• Pelvic ligaments arise from the sacrum, attaching to various segments of the pelvic bone.
• Additional ligaments provide pelvic support, extending from the pelvis to the lumbar spine.

Different Types of Pelvises

• Pelvic inlet: Boundary between the pelvic cavity and abdominal cavity, located at the sacral promontory and superior aspect of the pubic bones.
• Pelvic outlet: Inferior aspect of the pelvis, formed by the pubic arch, ischial spines, sacrotuberous ligaments, and the coccyx.
• True pelvis: Enclosed space between the inlet and outlet.
• Four pelvic "styles": Gynecoid, Android, Anthropoid, and Platypelloid.
• Gynecoid: Common in females, slightly oval inlet, blunted ischial spines, broad sacrum, ideal for vaginal delivery.
• Android: Common in males, heart-shaped inlet, conical ischial spines, slightly curved sacrum, ideal for muscle attachment.
• Anthropoid: Features of both android and gynecoid, oval inlet in the anteroposterior axis, blunt ischial spines, long and narrow sacrum.
• Platypelloid: Contracted pelvis, narrow inlet, broad outlet, decreased antero-posterior diameter, slightly curved sacrum.
• Female true pelvis: Shallower, flared sides, wider angle at pubic symphysis, larger pelvic outlet.
• Male true pelvis: Smaller, shorter distance between ischial spines, heart-shaped and narrower inlet.

Ligaments That Support the Female Pelvic Organs

• Round ligaments: Attach the uterus to the mons pubis, preventing excessive movement of the pregnant uterus.
• Broad ligament: A flat sheet of peritoneum associated with the uterus, fallopian tubes, and ovaries.
• Uterosacral ligaments: Attach the upper vagina, cervix, and uterus to the 3rd sacral vertebra, providing posterior stability.
• Cardinal ligaments: Attach the upper vagina, cervix, and uterus to the sidewalls of the pelvis.

Endopelvic Fascia

• Endopelvic fascia: Connective tissue network enveloping the pelvic viscera and pelvis, consisting of parietal fascia (covering pelvic muscles) and visceral fascia (covering pelvic organs).
• Three levels of endopelvic fascial support in women:
  • Level 1: Suspends the upper portion of the vagina and cervix.
  • Level 2: Supports the middle portion of the vagina and posterior bladder wall.
  • Level 3: Attaches the lower portion of the vagina to the perineal membrane, including urethral suspensory ligaments.

External Female Genitals

• Vulva: Collective term for external female reproductive structures.
• Mons pubis: A pad of fat over the pubic bone.
• Labia majora: Hair-covered skin folds posterior to the mons pubis.
• Labia minora: Thinner, pigmented folds medial to the labia majora, protecting the urethra and entrance to the reproductive tract.
• Clitoris: An organ with abundant nerves, important for sexual sensation and orgasm.
• Hymen: A thin membrane partially covering the entrance to the vagina.
• Vaginal opening: Located between the urethra and anus, flanked by outlets to the Bartholin’s glands.

Vagina

• Muscular canal (approximately 10 cm long) serving as the entrance to the reproductive tract and exit for menses and childbirth.
• Outer walls form longitudinal columns, or ridges.
• Fornix: Superior portion of the vagina meeting the protruding cervix.
• Walls lined with outer adventitia, middle smooth muscle layer, and inner mucous membrane with rugae.
• Hymen: Thin membrane, ruptures with exercise, intercourse, or childbirth.
• Bartholin’s glands and lesser vestibular glands secrete mucus to keep the vestibular area moist.
• Home to microorganisms, predominantly Lactobacillus, maintaining an acidic pH (below 4.5) for protection against pathogens.

Uterus and Cervix

• Uterus: Muscular organ supporting the growing embryo (approximately 5 cm wide by 7 cm long when not pregnant).
• Fundus: Portion superior to the opening of the uterine tubes.
• Body (corpus): Middle section of the uterus.
• Cervix: Narrow inferior portion projecting into the vagina, producing mucus secretions that facilitate sperm movement.
• Wall consists of three layers: serous membrane (perimetrium), myometrium (smooth muscle for contractions), and endometrium (connective tissue lining).

Clitoris

• Erectile structure, homologous to the male penis, located inferior to the mons pubis.
• Composed of paired crura, a body, and a glans.
• It is not circumscribed by a foreskin nor is it perforated by the urethra
• Four-fifths of the clitoris is internal with only its glans, measuring an average length of 5 to 8 mm, externally positioned.
• During sexual arousal, fills with blood due to contraction of pelvic floor muscles, leading to ingurgitation and potential orgasm.

Penis

• External organ of the male reproductive system with two main functions: sexual intercourse and micturition.
• During sexual stimulation, it undergoes erection, and ejaculation occurs.
• Contains the urethra, which carries urine from the bladder.
• Structures include root, body and glans.
• The penis has three cylinders of erectile tissue: two corpora cavernosa, and the corpus spongiosum
• The glans is the most distal part of the penis which is conical in shape, formed by the distal expansion of the corpus spongiosum.

Erectile Tissues

• Root and body of the penis contain erectile tissue: crura and bulb in the root, corpora cavernosa and corpus spongiosum in the body.
• The corpus spongiosum expands distally to form the glans penis.

Neurovascular Supply

• Arterial supply: Dorsal arteries, deep arteries, and bulbourethral artery (branches of the internal pudendal artery).
• Venous drainage: Deep dorsal vein drains cavernous spaces into the prostatic venous plexus.

Prostate

• Part of the male reproductive system, located below the bladder and above the pelvic floor muscles.
• Produces fluid that makes up semen.
• Muscles ensure semen is forcefully expelled during ejaculation.
• The prostate is a gland about the size of a chestnut and weighs about 30 grams.
• "Penile fracture" in humans is the rupture of the fibrous covering of the corpora cavernosa, not an actual bone fracture.
• Approximately 50% of a penis’s length is housed inside the body

Bladder and Bowel

Bladder

• Organ of the urinary system.
• Consists of epithelium, lamina propria, muscularis propria/detrusor muscle, and perivesical soft tissue.
• The epithelial acts as a lining for the bladder
• The muscularis propria or detrusor muscle contracts to expel urine during micturition.
• The neck of the bladder is supported by pubocervical/pubourethral ligaments and fascia, active support by PFM, endopelvic fascia.
• External urethral sphincter: Skeletal muscle under voluntary control, surrounds the urethra.
• Sympathetic innervation (T10 – L2): Relaxes detrusor muscle, promoting urine retention.
• Parasympathetic innervation (S2-S4): Contracts detrusor muscle, stimulating micturition.
• Somatic innervation (S2-4): Innervates the external urethral sphincter, providing voluntary control over micturition.
• Sensory nerves in the bladder wall signal the need to urinate.
• The bladder is a hollow organ with distensible walls.
• It has a folded internal lining (known as rugae)

Bladder Stretch Reflex

• Micturition stimulated in response to stretch of the bladder wall.
• Bladder walls stretch, sensory nerves transmit to the spinal cord.
• Interneurons relay signal to parasympathetic efferents, pelvic nerve contracts detrusor muscle.

Normal Voiding

• Requires a functioning central nervous system, a contractile bladder, and urethral relaxation.
• Normal bladder holds 300-400ml during the day and 500-600ml overnight.
• Voiding frequency: Six times per day and zero to once overnight in people under 65 years of age. Over 65 years of age daily void frequency increases to around seven times a day and once overnight.
• Voiding eight times a day and twice overnight is considered pathological.

Bladder Diaries

• Used to collect information about urinary storage and output.
• Completed for three days, measures fluid intake, bladder volumes, voiding frequency, and urge.

Bowel

• Works to digest food, absorb nutrients, and expel waste.
• Small intestine: 6 meters long, absorbs nutrients.
• Colon: 1.5 meters long, absorbs water.
• Rectum: Stores waste material.
• Sympathetic nervous supply to the rectum is from the lumbar splanchnic nerves and the superior and inferior hypogastric plexuses.
• Parasympathetic supply is from S2-4 via the pelvic splanchnic nerves and inferior hypogastric plexuses.
• The anal canal is surrounded by internal and external anal sphincters
• Internal anal sphincter: surrounds the upper 2/3 of the anal canal
• External anal sphincter: surrounds the lower 2/3 of the anal canal

Bowel Habits

• Vary between individuals, but most need to defecate 30 minutes after a meal.
• Stool formation and ease of defecation are important.
• Anything from several times a day to several times a week can be normal

Bristol Stool Chart

• Classifies feces into seven categories.
• Type 1-2 indicate constipation, Type 3-4 are ideal, Type 5-7 may indicate diarrhea and urgency.

Colorectal and Colonic Motility

• Colorectal and colonic motility refers to the movement of food and waste through the colon.
• Involves Segmental and Propagating complexes, Anterograde contractions propel gut contents towards the anus.
• Retrograde: Propel gut contents towards the mouth.
• Rectal Motility triggered by the arrival of stool into the rectum.

Control of Colonic Motility

• Sleep has an inhibitory effect on the gut.
• Eating increases segmental and propagating complexes, overall colonic tone, colonic sensitivity and rectocolonic reflexes.
• Physical stress causes a simultaneous increase in segmental contraction of differing areas of the bowel via a mediated via autonomic pathways.
• Psychological stress causes slow gastric emptying but accelerates colonic transit with increased activity persisting in the absence of stress.

Normal Bowel Function

• Ability to hold on after the first urge to defecate.
• Pass a stool within approximately 1 minute of sitting to defecate.
• Pass a stool without strain or pain.
• Completely empty the bowel.

Bowel Diary

• Used to record stools and defecation to assist in the treatment of bowel dysfunction.
• Should be recorded for seven days

Fibre

• Soluble fibre becomes part of your stool making a well-formed stool.
• Insoluble fibre helps to “sweep” feces out.
• It is recommended that adult females consume 25g of fibre/day and adult males 30g per day.

Water

• Essential for good gut motility and defecation.
• Most foods, even those that look hard and dry, contain water.

Flatulence

• Normal bodily function, result of bacteria breaking down food in the large intestine.
• Average adult produces a median 705 millilitres of gas every day.

The Pelvic Floor Muscles

• The pelvic floor is a group of muscles that support the pelvic organs and help with urinary and fecal continence.

The Perineum

• The anterior half of the perineum is the urogenital triangle.
• The posterior portion of the perineum is called the anal triangle.
• The perineal body, also referred to as the central tendon of the perineum, is a fibro-muscular structure located in the midline of the perineum.

Urogenital Triangle

• Bounded by the pubic symphysis, ischiopubic rami, and a theoretical line between the two ischial tuberosities.
• Contains several muscles important for sexual function and urinary control: Bulbospongiosus, Ischiocavernosus, Superficial transverse perineal
• Bulbospongiosus and Ischiocavernosus muscles assist with voiding by emptying the urethra after micturition Bulbospongiosus also expels semen or vaginal secretions during the ejaculatory process. Bulbospongiosus acts as a sphincter to close the vaginal opening.

Intermediate Layer

• It is known as the perineal membrane or urogenital diaphragm.
• Its function is to work in conjunction with the external urethral sphincter.
• Contains: Urethral sphincter and Compressor urethrae and deep transverse perineal

Levator Ani

• A wide but thin muscular layer of tissue that forms the inferior border of the abdominopelvic cavity.
• Provides support to the pelvic viscera and resist increases in intra-abdominal pressure
• Assists urinary and fecal continence, and act in association with the internal and external anal sphincter during the process of defecation
• Assists in sexual function
• Assists in proper positioning of the foetal head during childbirth
• Supplied by sacral roots on its pelvic surface (S-2, S-3, and S-4) and by the perineal branch of the pudendal nerve on its inferior surface.

The Levator Ani Consists of Three Paired Striated Muscles

• Puborectalis supports the pelvic organs and regulates defecation. It is primarily supplied by the nerve to the levator ani (S4) and to a lesser degree the pudendal nerve (S2-4).
• Pubococcygeus lifts and draws forward, compresses the urethra, vagina, and anus. It is supplied by the pudendal nerve (S2,3) and from small branches of the sacral ventral rami (S2,3).
• Iliococcygeus presses the urethra and vagina against the pubis creating a functional sphincter. It is supplied by the pudendal nerve (S2,3) and from small branches of the sacral ventral rami (S2,3).

Anal Triangle

• Lacks any fascial components and is essentially a single layer made up of skeletal muscle, including the external anal sphincter.
• Contains the anal canal, anus and the external anal sphincter.
• Formed by the coccyx, sacrotuberous ligaments, and an imaginary line between the ischial tuberosities.

Characteristics of Pelvic Floor Muscles

• Type 1
  • Slow twitch and makes up 70%- 80% of fibres
  • Small motor neurons
  • Low power producers
  • Aerobic
  • Work for hours
• Type 2
  • Fast twitch and makes up 20-30% of fibres
  • Large motor neurons
  • High power producers
  • Anaerobic
  • Work for 1 min- 30 min
• Operate consciously and reflexively; comprised of type 1 and type 2 fibers.
• Muscles have strength, power, endurance, speed, agility, tone, and range of motion.
• They can become overactive and tight.

Other Muscles of the Pelvis That Can Impact Pelvic Health

• Obturator internus may play an important role in normal function of PFM.
• Piriformis also plays an important role in hip stability,

Training the Pelvic Floor Muscles

• Effective training of the pelvic floor muscles is crucial in promoting stability, support, and overall well-being
• Before we look at what is involved in pelvic floor muscle training let’s review muscle training principles.

Considerations for Muscle Training

• Individuality
• Specificity
• Volume
• Progression
• Reversibility

How Can We Assess Pelvic Floor Muscle Function?

• Objective assessment of the pelvic floor muscles to formulate a training program is the gold standard for treatment.
• External Visual Observation is the initial step in assessing pelvic floor muscle function.
• Real Time Ultrasound can be performed as a trans abdominal or trans perineal technique to assess pelvic floor muscle function.
• Transabdominal ultrasound is a non-invasive imaging technique
• Transperineal ultrasound has proven reliability and validity and is a powerful form of visual biofeedback.
• Internal digital examination may be performed vaginally, or rectally on a woman or a man.

Rating Pelvic Floor Muscle Strength

• Grading
  • The scale used most commonly by physiotherapists is the Modified Oxford Scale (MOS). This is a 6-point scale
  • Either of the above grading methods are acceptable to use.

Training the PFM

• There is level 1 evidence and Grade A recommendation for pelvic floor muscle training being offered as the first line treatment of incontinence, both urinary (stress, urge and mixed urinary) and faecal, and symptomatic pelvic organ prolapse (POP)

How to Perform a Pelvic Floor Muscle Squeeze?

• `Imagine what muscles you would tighten to stop yourself from passing wind or to ‘hold on’ from passing urine.
• ‘Tighten them around your front passage, vagina and back passage as strongly as possible and hold for three to five seconds.

Training the PFM

Exercise Positions

• Lying ➟ sitting ➟ standing ➟ movement and function
• The degree of difficulty increases as we increase the load on the pelvic floor muscles.

Pelvic Floor Muscle Training Program Design

• Consider:
  • PFM hold time
  • PFM rest time
  • Number of reps of endurance holds and number of quick squeezes
• Position for training
• Number of sessions per day/week- and when during the day these sessions will occur
• Explanation to the client on how to perform a pelvic floor muscle contraction

Adherence

• Adherence to pelvic floor muscle training is considered crucial to short- and long-term success
• Long term adherence to PFMX is poor with only 50% adherence to a training program at 12 months.
• The patient’s perception of minimal benefit of the therapy and reduced self-efficacy, poor identification with pelvic anatomy may lead to low motivation to adhere to PFMX.

Keys Factors in Goal Setting

• Break the task down and break the goal down into smaller parts
• Revisit goals and modify as required.

Consent

• Before any assessment or treatment is carried out, you must ask a client for their consent.
• Inform the client about the procedure, possible effects, likely success, risks, benefits and alternatives (informed consent).
• The client can change their mind and withdraw their consent at any time.

Pelvic Health Life Stages

Pregnancy

• During pregnancy a woman’s body goes through immense changes involving all organ systems to sustain the growing foetus.
• These changes include significant hormonal changes to ensure a healthy pregnancy and successful birth

Hormone Changes and Effects

• HCG hormone plays a part in the nausea and vomiting often linked to pregnancy.

Pelvic Girdle Pain (PGP)

• PGP is pain experienced over the posterior and anterior pelvic girdle during pregnancy.
• Hormonal changes in pregnancy and the PP period influence connective tissue (ligament) stiffness
• PGP has also been shown to be linked to PFM weakness

Sacroiliac Dysfunction

• During gestation and in preparation for birth, the SIJ fibrous apparatus loosens.
• SIJ dysfunction in pregnancy is due to multiple biomechanical mechanisms

Symphysis Pubis Pain (SPP)

• SPP is pain felt over the pubic symphysis.
• Perinatal dilation of the symphysis by 3–5 mm is physiological

Treatment of PGP

• Exercise to strengthen muscles around the pelvis- gluteal, hip, abdominal and pelvic floor region
• Manual therapy techniques such as soft tissue release

Round Ligament Pain

• Round ligament pain is experienced during pregnancy as a sharp pain over the lower, lateral abdominal wall
• Treatment for round ligament pain involves education about the round ligament’s role in pregnancy

Exercise and Pregnancy

• RANZCOG recommends that “women without contraindications should participate in regular aerobic and strength conditioning exercise during pregnancy”
• Benefits of exercise in pregnancy include: Prevention and management of gestational diabetes, prevention of excessive pregnancy weight gain and improved psychological wellbeing
• Risks of exercise in pregnancy: potential for injury, risk of falls and PF damage with high impact ex
• Specific recommendations for pregnancy exercise include: Avoidance of heavy weightlifting or activities that involve straining or breath holding, avoidance of strength training exercises in supine and avoid overheating during exercise

Labor

There are 3 stages of labour:

First stage

• This stage begins when the cervix starts to soften and to open. First stage is complete when the cervix has opened to around 10cm.

Second stage

• the period of time from when the cervix is fully dilated to when the baby is born.

Third stage

• begins after the baby is born and finishes when the placenta and membranes have been delivered.

Vaginal Delivery and Obstetric Anal Sphincter Injury (OASI)

• Approximately 40% of primiparous women sustain a second-degree perineal tear, 7.4% sustain an obstetric anal sphincter injury (OASI), and 8.7% an episiotomy. -OASI increase a woman’s risk of FI and are the leading cause of FI in women.
• Specific recommendations for pregnancy exercise include: Avoidance of heavy weightlifting or activities that involve straining or breath holding, avoidance of strength training exercises in supine and avoid overheating during exercise

PFM damage during vaginal delivery

• Vaginal childbirth is the most common mode of delivery, and it is associated with increased incidence of pelvic floor disorders later in life.
• Vaginal delivery has been identified as a risk factor for levator injury.

Postpartum

• Postpartum women are in an hypoestrogenic state thinning the vaginal mucosa and vulvovaginal atrophy and also resulting in an increased risk of SUI

Diastasis of the Rectus Abdominus Muscle (DRAM)

• Divarication of the recti is a stretching of the linea alba with abnormal widening of the gap between the two medial sides of the rectus abdominis muscle.
• 31.5% of women have been found to have DRAM of 2-3 finger width at three months post-partum.

It is associated with impaired abdominal strength-

The size of the IRD was negatively associated with abdominal muscle function- the larger the IRD the more abdominal function was negatively impacted

Treatment of DRAM

• Treatment involves restoration of PFM and abdominal muscle function, strength and control.

Exercise recommendations in the postpartum period

• 0-6 WEEKS Need to choose low impact exercise options and low resistance exercise
• 6-12 WEEKS Exercise can be increased to include progressive increase in resistance and cardiovascular exercise
• 12 WEEKS ONWARD Commencement of high impact exercise and increased resistance exercise as per pre pregnancy

Menopause and Pelvic Organ Prolapse (POP)

Menopause

• Refers to the last or final menstrual period. When a woman has had no periods for 12 consecutive months, she is considered to be postmenopausal.
• Menopause is associated with adverse metabolic and bone changes leading to an increased risk of cardiovascular disease and osteoporosis, as well as urogenital symptoms.
• Post menopausal women need to participate in regular physical activity

Pelvic Organ Prolapse (POP)

• Pelvic organ prolapse (POP) is a gynaecological condition in which the pelvic organs herniate into the vagina due to biomechanical failure of pelvic tissues.
• The risk of POP is increased by; vaginal delivery, age and, Women with levator ani defects are at least twice as likely to show clinically significant pelvic organ prolapse Risk factors and pelvic organ prolapse
• Demographics: Age, Postmenopausal status
• Obstetric factors: Parity Instrumental vaginal delivery

Physiotherapy Treatment for POP

Two important considerations for treatment of POP are:

1. PFM training
2. Lifestyle advice

PFM training

• As POP is associated with a weakened levator system PFM training has been shown to increase PFM thickness and elevate the bladder and rectal ampula

Lifestyle advice

• Exercise: exercise choices will depend upon a woman’s level of fitness. Exercise history, co-morbidities and interests
• Bowel advice to prevent straining and reduce pelvic floor loading through education on defecation dynamics and positioning, and fluid and fibre advice -Vaginal support devices e.g. vaginal pessary, can be used to provide support for the pelvic floor allowing continuation of higher impact and resistance exercise in many women

Radical Prostatectomy (RP)

• A radical prostatectomy is a surgical procedure for the complete removal of the prostate, most commonly performed to treat prostate cancer.

Post operative issues

• Post operative issues include urinary incontinence and erectile dysfunction. Urinary incontinence post RP most commonly occurs as SUI but may also be UUI if clients experience bladder urgency preoperatively.

Causes of Post OP UI

• UI post RP has an aetiological diversity with many causes including pre, intra and post op factors being suggested as causes.
• Postoperatively- timing of PFM exercise post operatively with earlier commencement leading to earlier recovery of continence.
• Erectile dysfunction (ED) Recovery of sexual function may take up to two years or more after surgery and may not be complete.
• Physiotherapy treatment post surgery: Education including PFM anatomy and function, and benefits of PFM training
• PENILE REHABILITATION Penile rehabilitation post RP is important for maintenance of vascular and cellular integrity Physiotherapy treatment for ED involves: PFM training discussion and encouragement of sexual intimacy, either partnered or unpartnered education on vacuum erection devices (VED). Outcome measures measure client improvement and the effectiveness of the physiotherapy treatment using standardised, validated clinical outcome measures.