Vaginoscopy vs Traditional Hysteroscopy for Fibroids

Overseen By Carol-Anne VALLÉE, MD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Disqualifiers: Cervical stenosis, Pregnancy, Blood dyscrasia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two methods to remove fibroids or polyps in women with abnormal uterine bleeding or fertility issues. The researchers aim to determine if vaginoscopy, which uses less invasive techniques, causes less pain than traditional hysteroscopy. The treatments include standard hysteroscopy with sedation and vaginoscopy with sedation. Women diagnosed with a small fibroid or polyp might be suitable candidates for this trial. As an unphased trial, it offers participants a unique opportunity to contribute to research that could enhance treatment options for women with similar conditions.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these techniques are safe for hysteroscopic morcellation?

Research has shown that both vaginoscopy and traditional hysteroscopy are generally well-tolerated. However, differences exist in pain perception. One study found that women who were sedated reported less pain with traditional hysteroscopy compared to vaginoscopy.

While safety concerns exist regarding a procedure called morcellation, these primarily involve the risk of spreading unexpected cancerous tissue in other types of surgeries. This concern does not directly relate to vaginoscopy or traditional hysteroscopy for fibroid removal.

Overall, both procedures are considered safe, with mild discomfort being the most common issue. Prospective trial participants should discuss any concerns with their healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it compares two techniques used to remove fibroids: traditional hysteroscopy and a newer approach called vaginoscopy. What's intriguing about vaginoscopy is that it simplifies the procedure by eliminating the need for a paracervical block, relying solely on intravenous sedation. This could mean a more comfortable and less invasive experience for patients. By exploring these differences, the trial aims to uncover whether vaginoscopy offers advantages in terms of patient comfort and procedure efficiency compared to the standard method.

What evidence suggests that this trial's treatments could be effective for reducing pain perception during hysteroscopic morcellation?

This trial will compare vaginoscopy with traditional hysteroscopy for treating uterine fibroids. Research has shown that using a camera through the vagina, known as vaginoscopy, can effectively treat uterine fibroids. However, some studies suggest that vaginoscopy might cause more pain compared to the traditional method, hysteroscopy. In hysteroscopy, a camera is inserted into the uterus through the cervix, often resulting in less pain, especially with sedation. Both methods aim to remove fibroids, which are non-cancerous growths in the uterus, but the traditional method might be less painful. These factors are important to consider when choosing a treatment for fibroids. ^{4 6 7 8 9}

Who Is on the Research Team?

Carole KAMGA-NGANDE, MD

Principal Investigator

Centre hospitalier de l'Université de Montréal (CHUM)

Are You a Good Fit for This Trial?

This trial is for women aged 18-52 who need a polypectomy or myomectomy due to abnormal bleeding or fertility issues. They must have small polyps or fibroids previously diagnosed by hysteroscopy. Women with large fibroids, cervical stenosis, blood disorders, or pregnancy cannot participate.

Inclusion Criteria

Polyp or fibroid previously diagnosed by hysteroscopy

My polyp is smaller than 2 cm.

My fibroids are 4 cm or smaller in total if I have more than one.

Exclusion Criteria

Pregnancy

I have a narrowed cervical canal.

I have a blood disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either traditional hysteroscopy or vaginoscopy for hysteroscopic morcellation under intravenous sedation

1 day

1 visit (in-person)

Follow-up

Participants are monitored for pain perception and complications immediately after the intervention

immediately after intervention

1 visit (in-person)

Long-term Follow-up

Participants are monitored for time to pregnancy and continuation of fertility treatment

up to 1 year

What Are the Treatments Tested in This Trial?

Interventions

• standard hysteroscopy
• vaginoscopy

Trial Overview The study compares pain levels between two procedures: vaginoscopy and traditional hysteroscopy during outpatient treatment of uterine conditions like fibroids. The hypothesis is that vaginoscopy causes less pain than the standard method.

How Is the Trial Designed?

Group I: Vaginoscopy Experimental Treatment 1 Intervention

morcellation hysteroscopy with only intravenous sedation

Group II: Standard hysteroscopy Active Control 1 Intervention

morcellation hysteroscopy with intravenous sedation and paracervical bloc

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials

389

Recruited

143,000+

Hologic, Inc.

Industry Sponsor

Trials

48

Recruited

59,900+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12065966/

Patterns and Outcomes in the Management of Uterine ... The aim of this study was to evaluate the clinical patterns, treatment modalities, and patient outcomes associated with uterine fibroids.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0301211525008206

Pain perceived during hysteroscopic morcellation by ... In conclusion, our data demonstrate that in an outpatient setting, women under sedation experience less pain with the standard technique than with vaginoscopy ...

3. frontiersin.org frontiersin.org/journals/global-womens-health/articles/10.3389/fgwh.2025.1601341/pdf

Evaluating treatment options for symptomatic uterine fibroids Changes in vaginal discharge are common after UAE. Results from two studies involving 255 patients showed a pooled incidence rate of vaginal ...

4. gpm.amegroups.org gpm.amegroups.org/article/view/10206/html

Uterine fibroids: a narrative review of epidemiology and ... One study showed reduction in fibroid size up to 76% at 10 months follow-up (46). A randomized trial comparing UAE and laparoscopic uterine artery occlusion ...

5. mdpi.com mdpi.com/1648-9144/60/6/868

Currently Available Treatment Modalities for Uterine Fibroids It is a safe and effective therapeutic option associated with shorter hospitalization and reduced intraoperative blood loss in comparison to ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK537749/

Study Outcome Data - Management of Uterine Fibroids - NCBI We extracted intermediate and final health outcomes from all studies included for KQ 1. We recorded data on 414 discreet outcome measures representing 19 ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37244458/

Long-term health-related quality of life and symptom ... All treatment modalities were associated with significant improvements in health-related quality of life and symptom severity reduction ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2949838424000227

Review An update on the management of uterine fibroids The aim of the present review is to highlight the basic and clinical research advancements in the diagnosis and treatment of UFs.

9. acog.org acog.org/clinical/clinical-guidance/committee-opinion/articles/2021/03/uterine-morcellation-for-presumed-leiomyomas

Uterine Morcellation for Presumed Leiomyomas The use of laparoscopic power morcellators during fibroid surgery may spread cancer and decrease the long-term survival of patients. This information should be ...