Fondazione IRCCS Policlinico San Matteo, SC Ostetricia e Ginecologia 1
Pavia, 27100, Italy
Location status: Recruiting
NCT Number: NCT07180524
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.
Interested in participating?
Request Info35 year–55 year
Female
Observational
Pavia, 27100, Italy
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: at baseline, immediately after the surgery, 1 month after surgery, 6 and 12 months after surgery
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, 6 and 12 months after surgery
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
Compare of the pelvic hiatus over time in patients who underwent total hysterectomy compared to those who underwent myomectomy.
Contact information is provided by the study sponsor or research team.
Fondazione IRCCS Policlinico San Matteo di Pavia
Other
Prospective Clinical Trial on the Impact of Uterine Fibromatosis Surgery on Pelvic Floor.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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