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

NCT07180524 | Recruiting DMC

• 1 other identifier: FIBROPELV
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Floor Dysfunction; Fibromatosis

Outcome Measures

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.

  at baseline, immediately after the surgery, 1 month after surgery, 6 and 12 months after surgery

Secondary Outcomes (2)

• pelvic floor biometry

  at baseline, immediately after the surgery, 1 month, 6 and 12 months after surgery

• pelvic floor biometry

  at baseline, immediately after the surgery, 1 month, 6 and 12 months after surgery

Study Arms (1)

uterine fibromatosis

patinets with uterine fibromatosis will undergo hystrectomy or myomectomy

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients with symptomatic uterine fibromatosis and candidates for surgical treatment aged between 40 and 55 years will be consecutively enrolled.

You may qualify if:

• Symptomatic uterine fibromatosis with intramural and/or subserosal myomas identified by ultrasound and topographically mapped
• Patients with scheduled hysterectomy or myomectomy

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (1)

Fondazione IRCCS Policlinico San Matteo, SC Ostetricia e Ginecologia 1

Pavia, Pavia, 27100, Italy

RECRUITING

Related Publications (2)

• Shaffer RK, Dobberfuhl AD, Vu KN, Fast AM, Dababou S, Marrocchio C, Lum DA, Hovsepian DM, Ghanouni P, Chen B. Are fibroid and bony pelvis characteristics associated with urinary and pelvic symptom severity? Am J Obstet Gynecol. 2019 May;220(5):471.e1-471.e11. doi: 10.1016/j.ajog.2019.01.230. Epub 2019 Jan 31.

  PMID: 30711512 BACKGROUND

• Dagur G, Suh Y, Warren K, Singh N, Fitzgerald J, Khan SA. Urological complications of uterine leiomyoma: a review of literature. Int Urol Nephrol. 2016 Jun;48(6):941-8. doi: 10.1007/s11255-016-1248-5. Epub 2016 Feb 27.

  PMID: 26922066 BACKGROUND

MeSH Terms

Conditions

Fibroma

Condition Hierarchy (Ancestors)

Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Arsenio Spinillo

CONTACT

+39382503267; spinillo@smatteo.pv.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: September 18, 2025
• Study Start: June 30, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

IT (1)