Current Clinical Trial Research in Female Pelvic Medicine and Reconstruction

Objectives: The objective of this study was to conduct a cross-sectional analysis of current, late phase clinical trial research in female pelvic medicine and reconstructive surgery, with a focus on identifying the types of interventions being used and the conditions being treated.

Methods: To identify current clinical trials in female pelvic medicine and reconstructive surgery, a search was performed in the National Library of Medicine's clinical trials database (ClinicalTrials.gov) to identify urogynecologic trials that were active or enrolling participants on the date of the search (03/03/2023). We then classified the trials based on their condition, type of intervention, phase of trial, and location.

Results: Our search identified 228 clinical trials, with 137 (60.09%) being conducted in the United States. Of the trials identified, the majority were recruiting participants (71.93%), while 24.12% were active but not recruiting and 3.95% were enrolling by invitation (Table 1). The most common condition being studied was cancer (36.84%), followed by infection (17.98%) and obstetrics (11.40%). The interventions used most frequently were drugs (80.26%), followed by procedures (10.53%), devices (3.95%), and other interventions (5.26%). When considering the interventions used for specific conditions, drug interventions were the most common for cancer, infection, and obstetrics, while procedures were the most common for bladder dysfunction and pelvic organ prolapse (Table 2). Our analysis also revealed that the majority of the trials were in phase 2 (44.74%) or phase 3 (41.23%) of their respective trial processes. This suggests that many of the interventions being studied have already undergone preclinical testing and have shown some promise in their initial clinical testing

Conclusions: This cross-sectional analysis provides insight into the current landscape of clinical trials in female pelvic medicine and reconstructive surgery, highlighting the prevalence of certain conditions and interventions. The findings may guide future research and aid in the development of novel interventions for these conditions. One limitation of our study is that our search only included clinical trials listed in the National Library of Medicine's database. While this is a comprehensive database, it is possible that there are additional trials that were not captured in our search. Additionally, our search was limited to trials that were active or enrolling participants, and did not include trials that had been completed or terminated. Despite these limitations, our study provides valuable information about the current state of clinical research in female pelvic medicine and reconstructive surgery. The prevalence of cancer as a studied condition suggests a significant need for improved interventions in this area, while the predominance of drug interventions highlights the importance of pharmacological therapies in this field. These findings can guide future research and ultimately lead to improved patient outcomes in the treatment of female pelvic medicine and reconstructive surgery conditions.