An observational study in Pelvic Floor Dysfunction and Fibromatosis, sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia. Recruiting at 1 site in Italy. Open to female participants aged 35 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-18.
Sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia · Observational
Uterine fibromatosis is one of the most frequent gynecological conditions; in fact, uterine fibroids involve approximately 25-30% of women during the fertile period. Risk factors for the development of this pathology include age, family history and ethnicity. Multiparity, advanced age for pregnancy and smoking appear to be protective factors.
Myomas are responsible for numerous symptoms reported by patients, such as menometrorrhagia, pelvic pain and urinary and/or deficatory symptoms. Although myomas are asymptomatic in almost 50% of cases, they represent the first cause of hysterectomy for benign pathologies (about 2/3 of cases). Urinary symptoms associated with myomas are rarely studied in patients with symptomatic uterine fibromatosis; therefore the impact that this pathology has on the symptoms related to pelvic-perineal dysfunction and what their prevalence is is not well known at present. The prevalence of urinary symptoms in women with uterine myomas is highly variable based on literature data and the studies considered; in fact, the most frequently reported urinary symptoms are urinary urgency (31-59%), dysuria (4-36%) and stress urinary incontinence (20-80%). Furthermore, there is currently no unanimous agreement between the topography and size of myomas and related urinary and pelvic symptoms.
The type of treatment varies from single or multiple myomectomy to hysterectomy performed laparoscopically or laparotomy. The choice of surgical approach depends on the number, size and position of myomas. To date, few studies have evaluated the impact of the type of surgical treatment on pelvic floor symptoms. In fact, although hysterectomy is considered a risk factor for the onset of pelvic floor disorders, removal of the uterus can sometimes improve urinary symptoms. However, some authors report, equally, a significant improvement in urinary symptoms after myomectomy. Further studies are needed to clarify the impact of myoma treatment on urinary symptoms.
19 studies on the registry are indexed under Fibroma; 4 are open to participants now.
Browse Fibroma studies →Fondazione IRCCS Policlinico San Matteo di Pavia is the lead sponsor of 257 studies on the registry; 114 are open to participants now.
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Patients with symptomatic uterine fibromatosis and candidates for surgical treatment aged between 40 and 55 years will be consecutively enrolled.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
patinets with uterine fibromatosis will undergo hystrectomy or myomectomy
pelvic floor biometry
Compare the pelvic floor well-being of patients undergoing total hysterectomy compared to those undergoing myomectomy at 1 month, 6 and 12 months after surgery.
Time frame: at baseline, immediately after the surgery, 1 month after surgery, 6 and 12 months after surgery
pelvic floor biometry
Compare pelvic hiatus area, anteroposterior diameter, and transverse diameter over time in patients who underwent total hysterectomy compared to those who underwent myomectomy.
Time frame: at baseline, immediately after the surgery, 1 month, 6 and 12 months after surgery
pelvic floor biometry
Compare of the pelvic hiatus over time in patients who underwent total hysterectomy compared to those who underwent myomectomy.
Time frame: at baseline, immediately after the surgery, 1 month, 6 and 12 months after surgery
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan
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