Prospective Clinical Trial on the Impact of Uterine Firomatosis on Pelvic Floor.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Pelvic Floor Dysfunction, Fibromatosis. Basic parameters: 35 years — 55 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective Clinical Trial on the Impact of Uterine Fibromatosis Surgery on Pelvic Floor.
Overview
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.
Primary outcome measures
- pelvic floor biometry [Time frame: at baseline, immediately after the surgery, 1 month after surgery, 6 and 12 months after surgery]
Secondary outcome measures (2)
- pelvic floor biometry [Time frame: at baseline, immediately after the surgery, 1 month, 6 and 12 months after surgery]
- pelvic floor biometry [Time frame: at baseline, immediately after the surgery, 1 month, 6 and 12 months after surgery]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Fondazione IRCCS Policlinico San Matteo, SC Ostetricia e Ginecologia 1 — Pavia
Publications
- 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
- 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
Identifiers
NCT: NCT07180524 · FIBROPELV