Please select the eligibility criteria that correspond to the clinical trial below.
Title: Reducing Perinatal Anal Incontinence Through Early Pelvic Floor Muscle Training: a Prospective Pilot Study
Brief Summary: Anal incontinence affects up to 20% of gravid women during and immediately after pregnancy. It can lead to embarrassment, poor self-image, lifestyle changes, in addition to poor hygiene and increased risk for genitourinary tract infection. These women suffer from a combination of loss of fecal and/or flatal control, with increasing frequency as pregnancy progresses. Though anal incontinence may subside in the postpartum period, a subset of women will have continued anal incontinence or recurrence of anal incontinence with subsequent pregnancies or as they age. As of December 2012, only one study has explored the effects of pelvic floor muscle training (PFMT) on reducing the development of this condition in the pregnant population. However, that study took place in Scandinavia with little demographic correlation to a US population and lacked postpartum followup. Although their results showed little effect of PFMT on anal incontinence, they recommended further research to be performed prior to making definitive conclusions.

Multiple studies have explored the effects of PFMT on urinary incontinence, and the general consensus shows a positive benefit, with a 50% incidence reduction. This study will serve as an initial test to explore whether such a positive relationship holds for anal incontinence throughout pregnancy and postpartum period for a diverse population. The format will be a prospective feasibility trial comprised of a one-time intensive in-person pelvic floor muscle training course at the first prenatal visit with at home instructions for continued exercise. This group will be compared to a control group which receives a hand-out regarding PFMT but no personalized instruction. The progress of the participants and their symptoms of incontinence will be monitored during pregnancy and at the postpartum visit using standardized validated pelvic floor questionnaires, based on previously designed surveys. A sample size of 100 parous women ages 20-35 year old will be randomized to an intervention and "control or standard therapy" group. The investigators' hypothesis is that the intervention group will show a 50% risk reduction, similar to the urinary incontinence studies. The results of this study will then allow us to design a broader intervention study for which to study the effects of PFMT and anal incontinence during pregnancy and the postpartum period.


Options:
A: Inclusion Criteria:

* parous women
* ages 20-40year old
* a new Ob visit prior to 20 weeks gestation
* confirmed singleton live intrauterine pregnancy

Exclusion Criteria:

* prior history of anal incontinence or prolapse
* history of surgery or procedures for urinary or anal incontinence or pelvic organ prolapse
* tobacco use
* diabetes mellitus
* history of sexual trauma
* chronic cough
* chronic constipation based on Rome criteria
* known connective tissue disorder
B: Inclusion Criteria:

* Urgency urinary incontinence or mixed urinary incontinence, established via telephone interview
* Urinary leakage twice a week or more often
* Duration of urinary leakage with urgency for at least 12 months
* Ability to read and write Swedish
* Asset to a smartphone (minimum iOS\* 8.0 for Apple, 4.0.3 for Androids
* Possibility to send and receive email and asset to printer
* Motivation and time to perform a 15 weeks long treatment programme with focus on self-care and behavioural training (mainly pelvic floor muscle training and bladder training).
* Accept to be randomized to one of two groups; a treatment app group or an information app Group

  * iOS=mobile operating system including iPhone, iPad and iPod touch

Exclusion Criteria:

* Participation in our previous internet or smartphone study
* Ongoing pregnancy
* Former incontinence surgery
* Known malignancy in lower abdomen
* Unassessed difficulties in emptying bladder
* Visual blood in urine
* Three or more urinary tract infections during the last 12 months
* One or more pyelonephritis during the last three years
* Painful micturition
* Painful urgency
* Intermenstrual bleeding
* Neurological disease such as multiple sclerosis or Parkinsons disease
* Previous stroke
* Diabetes mellitus
* Maximum voided volume of less than 150 ml (micturition chart)
* Regular use of any mobile app for pelvic floor muscle training during the last month
* Usage of antimuscarinic drugs or mirabegron during the last month
C: Inclusion Criteria:

* Pre-pregnancy body mass index of 28 or more
* 18 years or more
* singleton live fetus at the routine ultrasound scan

Exclusion Criteria:

* high risk for preterm labor or diseases that could interfere with participation
D: Inclusion Criteria:

* Being healthy and able to exercise following American College of Obstetricians and Gynecologists (ACOG) guidelines
* Being able to communicate in spanish
* Giving birth at Hospital Universitario de Torrejón, Hospital Universitario de Puerta de Hierro or Hospital Universitario Severo Ochoa (Madrid)

Exclusion Criteria:

* Multiparity
* Obstetrician complications
* Being interested in the study after 18 weeks
* Not having availability to attend to the physical exercise program
* Younger than 18 years old
* Older than 45 years old

Answer: A