Please select the arm or intervention descriptions that belong 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: Arm Label: Pelvic floor training; Type: ACTIVE_COMPARATOR; Interventions: Other: Pelvic floor training | Arm Label: Literature-only group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Pelvic floor training; Assigned to Arm(s): Pelvic floor training
B: Arm Label: Tät®II Treatment app; Type: EXPERIMENTAL; Interventions: Device: Tät®II Treatment app | Arm Label: Tät®II Information app; Type: OTHER; Interventions: Device: Tät®II Information app | Intervention Type: DEVICE; Name: Tät®II Information app; Assigned to Arm(s): Tät®II Information app | Intervention Type: DEVICE; Name: Tät®II Treatment app; Assigned to Arm(s): Tät®II Treatment app
C: Arm Label: Exercise training; Type: EXPERIMENTAL; Interventions: Behavioral: Exercise | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Exercise; Assigned to Arm(s): Exercise training
D: Arm Label: Control Group; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Exercise Group; Type: EXPERIMENTAL; Interventions: Behavioral: Exercise Group | Intervention Type: BEHAVIORAL; Name: Exercise Group; Assigned to Arm(s): Exercise Group

Answer: A