Skip to content

Prospective Clinical Trial on the Impact of Uterine Firomatosis on Pelvic Floor.

Prospective Clinical Trial on the Impact of Uterine Fibromatosis Surgery on Pelvic Floor.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07180524
Enrollment
200
Registered
2025-09-18
Start date
2024-06-30
Completion date
2029-12-31
Last updated
2025-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromatosis, Pelvic Floor Dysfunction

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.

Interventions

None listed

Sponsors

Fondazione IRCCS Policlinico San Matteo di Pavia
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
35 Years to 55 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
pelvic floor biometryat baseline, immediately after the surgery, 1 month after surgery, 6 and 12 months after surgeryCompare the pelvic floor well-being of patients undergoing total hysterectomy compared to those undergoing myomectomy at 1 month, 6 and 12 months after surgery.

Secondary

MeasureTime frameDescription
pelvic floor biometryat baseline, immediately after the surgery, 1 month, 6 and 12 months after surgeryCompare pelvic hiatus area, anteroposterior diameter, and transverse diameter over time in patients who underwent total hysterectomy compared to those who underwent myomectomy.

Countries

Italy

Contacts

Primary ContactArsenio Spinillo
spinillo@smatteo.pv.it+39382503267

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026