Prospective Clinical Trial on the Impact of Uterine Firomatosis on Pelvic Floor.
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age35-55
SponsorFondazione IRCCS Policlinico San Matteo di Pavia
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Symptomatic uterine fibromatosis with intramural and/or subserosal myomas identified by ultrasound and topographically mapped
Patients with scheduled hysterectomy or myomectomy
Disqualifiers
suspicion of malignant lesion.
active tumors
previous history of chemotherapy or radiotherapy
pregnancy
Trial population
Patients with symptomatic uterine fibromatosis and candidates for surgical treatment aged between 40 and 55 years will be consecutively enrolled.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
200 Participants
are grouped into 1 trial groupGroup A: uterine fibromatosis
Trial outcomes
Primary outcomes
1
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 surgerySecondary outcomes
1
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 surgery2
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 surgerySponsors and contacts
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Source ClinicalTrials.gov