NICHD established PFDN in 2001 to encourage collaborative research on pelvic floor disorders (PFDs) and to improve patient care. PFDs include pelvic organ prolapse, urinary and fecal incontinence, and other sensory and emptying abnormalities of the lower urinary tract and the gastrointestinal tract. As many as one in five women will have surgery for a PFD at some time in her life.
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 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 healthcare 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:
- Apical Suspension Repair for Vault Prolapse In a Three-Arm Randomized Trial Design
The primary purpose of this randomized clinical trial is to determine if transvaginal mesh placement is non-inferior to sacral colpopexy for anatomic correction of post-hysterectomy vaginal vault prolapse.
- Extended Operations and Pelvic Muscle Training in the Management of Apical Support Loss (E-OPTIMAL)
E-OPTIMAL was a dual randomized trial of women who have uterine or vaginal prolapse and stress urinary incontinence to compare the success and complications of two surgical procedures (sacrospinous ligament fixation and uterosacral ligament suspension). E-OPTIMAL extends follow-up to 5 years.
- 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 surgery alone.
- Refractory Overactive Bladder: Sacral NEuromodulation v. BoTulinum Toxin Assessment
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.
- 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.