Are fibroid and bony pelvis characteristics associated with urinary and pelvic symptom severity?
Robyn K Shaffer, Amy D Dobberfuhl, Kim-Nhien Vu...
https://pubmed.ncbi.nlm.nih.gov/30711512Actively Recruiting
Led by Fondazione IRCCS Policlinico San Matteo di Pavia · Updated on 2025-09-18
200
Participants Needed
1
Research Sites
52 weeks
Total Duration
Uterine fibromatosis, a common gynecological condition affecting about 25-30% of women during their fertile years, is associated with symptoms like heavy menstrual bleeding, pelvic pain, and urinary or bowel issues. Risk factors include age, family history, and ethnicity, while multiple pregnancies, older age at pregnancy, and smoking may offer some protection. Despite many cases being symptom-free, uterine fibroids are a leading cause of hysterectomy for benign conditions, and their impact on urinary and pelvic floor symptoms remains unclear. This research observes women with symptomatic uterine fibromatosis who are scheduled for either hysterectomy or myomectomy surgery. The study evaluates how these surgical treatments affect pelvic floor function by measuring pelvic floor biometry at multiple points: before surgery, immediately after, and at 1, 6, and 12 months following surgery. The goal is to better understand the relationship between fibroid treatment and pelvic floor symptoms. Participants will undergo ultrasound mapping of their fibroids before surgery. Researchers will monitor pelvic floor health through repeated biometry assessments over the year following surgery. This study tracks changes in pelvic floor function over time to assess the impact of the surgical approach chosen. The total participation period lasts up to 12 months post-surgery, with careful monitoring of pelvic floor outcomes.
CONDITIONS
Prospective Clinical Trial on the Impact of Uterine Firomatosis on Pelvic Floor.
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Day of surgery and immediately after
Participants undergo hysterectomy or myomectomy surgery with immediate post-operative assessments.
1 visit (in-person) on surgery day
Duration - 12 months
Participants have follow-up visits to assess pelvic floor biometry after surgery.
Visits immediately after surgery, at 1 month, 6 months, and 12 months after surgery
Total: 1 location
1
Fondazione IRCCS Policlinico San Matteo, SC Ostetricia e Ginecologia 1
Pavia, Pavia, Italy, 27100
Actively Recruiting
A
Arsenio Spinillo
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Have more questions? Get in touch with our team for quick support
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Robyn K Shaffer, Amy D Dobberfuhl, Kim-Nhien Vu...
https://pubmed.ncbi.nlm.nih.gov/30711512Gautam Dagur, Yiji Suh, Kelly Warren...
https://pubmed.ncbi.nlm.nih.gov/26922066