Pelvic Floor DysfunctionNCT07180524
Prospective Clinical Trial on the Impact of Uterine Firomatosis on Pelvic Floor.
An observational study of Pelvic Floor Dysfunction and Fibromatosis, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Floor Dysfunction, Fibromatosis
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 30 Jun 2024to 31 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Patients with symptomatic uterine fibromatosis and candidates for surgical treatment aged between 40 and 55 years will be consecutively enrolled.
Who may be able to join
- Symptomatic uterine fibromatosis with intramural and/or subserosal myomas identified by ultrasound and topographically mapped
- Patients with scheduled hysterectomy or myomectomy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Policlinico San Matteo, SC Ostetricia e Ginecologia 1
Pavia, Pavia, 27100
Arsenio Spinillo, +390382503267, spinillo@smatteo.pv.it
About this study
Official title: Prospective Clinical Trial on the Impact of Uterine Fibromatosis Surgery on Pelvic Floor.
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
- Medical subject headings
- Fibroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| uterine fibromatosis | patinets with uterine fibromatosis will undergo hystrectomy or myomectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at baseline, immediately after the surgery, 1 month after surgery, 6 and 12 months after surgery
Secondary outcomes (2)
pelvic floor biometry
Compare pelvic hiatus area, anteroposterior diameter, and transverse diameter over time in patients who underwent total hysterectomy compared to those who underwent myomectomy.
Measured: at baseline, immediately after the surgery, 1 month, 6 and 12 months after surgery
pelvic floor biometry
Compare of the pelvic hiatus over time in patients who underwent total hysterectomy compared to those who underwent myomectomy.
Measured: at baseline, immediately after the surgery, 1 month, 6 and 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start30 Jun 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pelvic Floor DysfunctionStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arsenio Spinillo, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07180524
- Sponsor's protocol ID
- FIBROPELV
- Status last verified
- Sep 2025
- First submitted
- 4 Mar 2025
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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.
PubMed 30711512Dagur 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.
PubMed 26922066
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Trial on the Impact of Uterine Fibromatosis Surgery on Pelvic Floor.
- ClinicalTrials.gov ID
- NCT07180524
- Acronym / sponsor ID
- FIBROPELV
- Conditions
- Pelvic Floor Dysfunction, Fibromatosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- 30 Jun 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 18 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| uterine fibromatosis | – | –patinets with uterine fibromatosis will undergo hystrectomy or myomectomy |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients with symptomatic uterine fibromatosis and candidates for surgical treatment aged between 40 and 55 years will be consecutively enrolled.
Key inclusion criteria (2 listed)
- Symptomatic uterine fibromatosis with intramural and/or subserosal myomas identified by ultrasound and topographically mapped
- Patients with scheduled hysterectomy or myomectomy
Key exclusion criteria (6 listed)
- suspicion of malignant lesion.
- active tumors
- previous history of chemotherapy or radiotherapy
- pregnancy
- age <18 years or >55 years (postmenopause)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
pelvic floor biometry
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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Background: PubMed 30711512Shaffer 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.
- Background: PubMed 26922066Dagur 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Floor Dysfunction and Fibromatosis, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arsenio Spinillo (+39382503267, spinillo@smatteo.pv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pelvic floor biometry (time frame: at baseline, immediately after the surgery, 1 month after surgery, 6 and 12 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07180524, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025; AzTrials last refreshed its copy on 8 Nov 2026.