NCT07180524 Prospective Clinical Trial on the Impact of Uterine Firomatosis on Pelvic Floor.
| NCT ID | NCT07180524 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia |
| Condition | Pelvic Floor Dysfunction |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-06-30 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2024-06-30 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: * Symptomatic uterine fibromatosis with intramural and/or subserosal myomas identified by ultrasound and topographically mapped * Patients with scheduled hysterectomy or myomectomy Exclusion Criteria: * suspicion of malignant lesion. * active tumors * previous history of chemotherapy or radiotherapy * pregnancy * age \<18 years or \>55 years (postmenopause) * history of pelvic static disorders prior to surgery
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07180524 clinical trial?
This trial is open to female participants only, aged 35 Years or older, up to 55 Years, studying Pelvic Floor Dysfunction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07180524 currently recruiting?
Yes, NCT07180524 is actively recruiting participants. Contact the research team at spinillo@smatteo.pv.it for enrollment information.
Where is the NCT07180524 trial being conducted?
This trial is being conducted at Pavia, Italy.
Who is sponsoring the NCT07180524 clinical trial?
NCT07180524 is sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia. The trial plans to enroll 200 participants.