NICHD established PFDN in 2001 to encourage collaborative research on pelvic floor disorders (PFDs) and to improve patient care. PFDs affect as many as one-third of U.S. women and include pelvic organ prolapse, urinary and fecal incontinence, and other sensory and emptying abnormalities of the lower urinary tract and the gastrointestinal tract.
PFDN includes eight clinical centers and a data coordinating center (DCC) located at U.S. universities and medical centers. Leadership at each clinical center is provided by a Principal Investigator (PI), who is a practicing physician with substantial experience in treating PFDs. A research coordinator oversees the progress of the PFDN's clinical trials under the supervision of the PI and a multidisciplinary team.
PFDN is funded through a Cooperative Clinical Research award mechanism (U10 and U01). A steering committee guides the development and conduct of research protocols and the preparation of PFDN publications. The steering committee is composed of the PIs from each clinical center, the DCC, a steering committee chair, and NICHD staff. A full listing of sites and investigators is available at https://pfdnetwork.azurewebsites.net/Home.aspx .
PFDN research aims to inform health care providers about diagnosis, care, and treatment of women with PFDs, while improving the quality of life for women with PFDs and their families.
General areas of research include observational and clinical studies examining the effectiveness of surgical and nonsurgical interventions for PFDs, including pharmacological agents, short- and long-term anatomical or functional outcomes of interventions (e.g., quality of life, sexual function, urinary function, and gastrointestinal function), and preventive strategies. New research into translating basic science findings to clinical outcomes is a routine part of each PFDN study. This effort will help to further investigate causes and pathologic changes that may contribute to differential outcomes in the clinical studies.
Network studies include the following:
- ABC (Anti-cholinergics versus Botox Comparison)
A randomized clinical trial of women who have urge incontinence (UI) to examine the effectiveness of Botox A® for reducing UI episodes, compared with standard therapy (anti-cholinergics).
- BOOST (Behavioral Therapy of Obstetric Sphincter Tears)
A cohort study to determine the postpartum incidence of fecal incontinence symptoms in women who have an obstetric anal sphincter injury.
- OPTIMAL (Operations and Pelvic Muscle Training in the Management of Apical Support Loss)
A dual randomized trial of women who have uterine or vaginal prolapse and stress urinary incontinence to compare the effectiveness of two surgical procedures (sacrospinous ligament fixation and uterosacral ligament suspension).
- E-OPTIMAL (Extended Operations and Pelvic Muscle Training in the Management of Apical Support Loss)
A study extending the follow-up of women in the OPTIMAL trial (up to 5 years) to compare the successes and complications of two surgical procedures.
- Refractory Overactive Bladder: Sacral NEuromodulation v. BoTulinum Toxin Assessment (ROSETTA)
This randomized, open-label, active-control trial compares the effectiveness of intra-detrusor botulinum toxin A (Botox A®, Allergan) versus sacral neuromodulation (InterStim®, Medtronic) for the treatment of refractory urge urinary incontinence. In addition, the study will evaluate select technical attributes of the interventions as well as the effect of these two interventions on other lower urinary tract and pelvic floor symptoms.
- SUPeR (Study of Uterine Prolapse Procedures Randomized) Trial
This trial compares symptom relief, durability, risks, and complications for two surgical approaches used for repair of uterine prolapse: Vaginal hysterectomy (removal of the uterus) with uterosacral ligament suspension, versus leaving the uterus in place and using the UPHOLD mesh system.
- CAPABLe (Controlling Anal incontinence by Performing Anal Exercises with Biofeedback or Loperamide) Trial
This randomized placebo-controlled trial aims to learn more about medication and pelvic muscle training treatments for fecal incontinence. Specifically, this study compares the following treatments for fecal incontinence to see if one treatment or both together are better than usual care at improving fecal incontinence: loperamide only; pelvic muscle training only; loperamide and pelvic muscle training together; or usual care/placebo pill.
- ESTEEM (Effects of Surgical Treatment Enhanced with Exercise for Mixed Urinary Incontinence) Study
This combined treatment trial compares alternative treatment strategies for mixed urinary incontinence in women to determine whether combining surgery and behavioral/pelvic floor therapy works better than sling alone.