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Dyspareunia (Female)NCT07913386

Rigid Hymenal Ring as a Cause for Insertional Dyspareunia

An observational study of Dyspareunia (Female), run by Hadassah Medical Organization at 1 site in Israel.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Given the frequently observed rigid hymenal ring as a cause of insertional dyspareunia as well as the resolution of pain (including posterior vestibulodynia) following its targeted therapy, the study aims to describe its characteristics and assess response to surgical treatment in a prospective longitudinal cohort… Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Dyspareunia (Female)
What is being tested?
Hymenectomy
How many people
200 participants
Where
1 siteIsrael
Study dates
21 Jun 2024to Dec 2028
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 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Study population: Patients will be recruited from a vulvovaginal clinic.

Who may be able to join

  • Age 18-45
  • Pre-menopausal
  • Patient experience insertional dyspareunia
  • Self-reported sexual pain intensity ≥3 in the 0-10 Visual Analogue Scale (VAS) or complete avoidance of penetrative intercourse due to pain severity
  • On exam, presence of rigid hymen, with pain provoked by its lateral stretching. The pain should be clinically relevant, i.e., the patient identifies this provoked pain as pain familiar to her from intercourse or penetration attempts.
  • ASA I or II
  • BMI<35

Who cannot join

  • Previous vaginal delivery
  • Planned pregnancy in the upcoming year.
  • Previous hymenectomy, perineorrhaphy or vestibulectomy
  • Other identifiable causes for the pain, such as vulvovaginitis, dermatoses, scars etc.
  • Circumferential vestibular tenderness on Q-TIP examination
  • Major health conditions (cardiovascular, diabetes etc.)
Show all 9Show fewer
  • Diagnosis of an unstable psychiatric disorder
  • Difficult airway and/or major lung disease
  • A need for intubation during surgery

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ahinoam Lev-Sagie, Prof. contact

972-54-3217178

levsagie@netvision.net.il

Israel1 site, 1 recruiting
  • Hadassah Medical Center

    Jerusalem, 9765422

    Ahinoam Lev-Sagie, MD, levsagie@netvision.net.il

    Ahinoam Lev-Sagie, Prof., levsagie@netvision.net.il

    Recruiting

Other trials in Israel

About this study

Official title: Rigid Hymenal Ring as a Cause for Insertional Dyspareunia and Response to Surgical Treatment: a Prospective Longitudinal Cohort Study

Given the frequently observed rigid hymenal ring as a cause of insertional dyspareunia as well as the resolution of pain (including posterior vestibulodynia) following its targeted therapy, the study aims to describe its characteristics and assess response to surgical treatment in a prospective longitudinal cohort study.

Read the detailed description

It has been estimated that 10-40% of women suffer from dyspareunia, of whom many are not adequately diagnosed and treated. The severity can range from a total inability to tolerate penetration to a possible but painful experience.

Insertional pain can involve any anatomical structure within the vulva and vaginal entrance, and can result from various causes, with provoked vestibulodynia (PVD) being the most common diagnosis, affecting 12-21% of premenopausal women. PVD is attributed to various etiologies. As a result, it was suggested that PVD is not one disease but a constellation of symptoms of several (sometimes overlapping) disease processes with significant variation in the location, intensity, duration, and sensory quality of pain. Based on clinical observations, some practitioners and researchers have suggested that women with vestibulodynia can be sub-grouped into different etiologies, including hormonally mediated, pelvic floor hypertonicity, and neuroproliferation, based on the localization of vestibular pain and other parameters. Recently, our group have described that a rigid hymenal ring is associated with posterior vestibular allodynia and may be another cause for vestibular tenderness [Lev-Sagie].

Hymenal remnants are frequently observed and have no clinical significance, as the hymen usually will not produce pain on stretching and, therefore, not on penetration. However, an inelastic, rigid hymen (possibly containing excess amount of fibrous tissue) may cause mechanical narrowing at the vaginal opening with difficult and painful penetration, associated with stretching and distention of this tissue. Our data suggest that this finding is associated with posterior vestibular allodynia in an undefined mechanism.

A rigid hymen as a cause of dyspareunia and resultant vaginismus was described in the 70s of the 20th century. However, the research has not progressed appropriately regarding the association between rigid hymen and dyspareunia, and the phenomenon of "partially blocking" rigid hymen as an etiology for dyspareunia is not sufficiently acknowledged by caregivers as it has not been studied. Furthermore, due to inadequate awareness, the hymen is not routinely assessed in a gynecological physical examination; thus, the diagnosis is frequently missed.

Given the frequently observed rigid hymenal ring as a cause of insertional dyspareunia,we aim to describe its characteristics and assess response to surgical treatment in a prospective longitudinal cohort study.

Study Objectives:

  1. To describe and characterize rigid hymenal ring as a cause for insertional dyspareunia and a distinctive cause for PVD using clinical data and experimentally induced pain measures.
  2. To assess the degree of improvement in dyspareunia and change in experimentally induced-pain measures following surgical removal of the hymen
  3. To assess the associated factors affecting outcomes, such as catastrophizing, self-criticism and pain sensitivity etc., using suitable questionnaires.

Methods A prospective, longitudinal, cohort study evaluating clinical characteristics, dyspareunia severity, experimentally induced-pain measures, and response to treatment in women diagnosed with rigid, partially obstructing hymenal ring as the cause for insertional dyspareunia who undergo hymenectomy.

Patients scheduled for hymenectomy in Hadassah Mt. Scopus will be asked to participate in the study. After a detailed explanation and signing an informed consent form, they will undergo pre-operative evaluation including a detailed examination (see below) as well as questionnaires.

Under anesthesia, and before surgery, an assessment of introital circumference will be conducted using insertion of a conus shaped dilator, allowing exact measurement of the vaginal orifice, given that under anesthesia patients do not contract muscles. The surgery will be conducted using a similar protocol as well as the same anesthesia.

Hymenotomy will be conducted according to the usual procedure (which includes resection of the posterior portion of the hymen as well as longitudinal cut at the 6 o'clock position and transverse suturing) the final circumference achieved will be documented using the dilator.

Patients will be followed at 1,3,6,9 and 12 months following hymenectomy, to assess for the same parameters that were evaluated before hymenectomy.

Study parameters:

Experimentally induced-pain measures:

  • Vestibular tenderness evaluation using Q-tip, touching the vestibule gently at four defined points (2, 4, 8, and 10 o'clock).

To quantify pain intensity and to keep consistency between examiners, a pre-defined standardized pressure will be applied using algometer, and patients will be asked to quantify pain at the four points using a Numeric Pain Scale (NPS) ranging from 0-10 at each point.

  • Pressure-pain thresholds will be obtained in four defined vestibular locations (2, 4, 8, and 10 o'clock) using a vulvar-algesiometer.
  • Pelvic floor pressure pain threshold (PPT), hypertonicity and tenderness will be obtained using a digital calibration of the pressure with an algometer Additional questionnaires will be completed before the surgery, and will include
  • Pain Sensitivity Questionnaire-PSQ
  • PCS- Pain catastrophizing scale
  • Injustice Experience Questionnaire (IEQ)
  • Self-Compassion Scale (SCS)
  • Short Suggestibility Scale (SSS)
  • EXPECT questionnaire (short form)
  • Revised life orientation test
  • Female sexual function index (FSFI)- before surgery and in each appointment

3,6, 9 and 12 months follow up visits will include:

  1. self-report of dyspareunia using a 0-10 VAS.
  2. Experimentally induced pain measures: Q tip test at 4 locations . Pain thresholds . Muscle evaluation: hypertonicity, tenderness and pain thresholds (see detailed description above).
  3. FSFI questionnaire.
Being tested
Hymenectomy
Keywords
hymen, Provoked vestibulodynia
Medical subject headings
Dyspareunia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HymenectomyOther

    Hymenotomy will be conducted according to the usual procedure which includes resection of the posterior portion of the hymen as well as longitudinal cut at the 6 o'clock position and transverse suturing the final circumference achieved will be documented using the dilator.

Study groups in NCT07913386
Study groupRoleWhat they receive
Patients with insertional dyspareunia caused by rigid hymen, undergoing hymenectomy.Not described
Receives: Other: Hymenectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Improvement of dyspareunia

    Comparison of pain intensity ratings experienced during sexual intercourse, as reported by patients, using a 0-10 Visual Analogue Scale (VAS), with 0 meaning no pain, and 10 meaning the worst possible pain.

    VAS will be reported before the surgery and following treatment.

    Measured: before surgery, and at 3,6,9 and 12 months following hymenectomy.

Secondary outcomes (3)
  1. Change in vestibular tenderness.

    Vestibular tenderness evaluation assessed by touching the vestibule gently at four defined points (2, 4, 8, and 10 o'clock). To quantify pain intensity and to keep consistency between examiners, a pre-defined standardized pressure will be applied using algometer, and patients will be asked to quantify pain at the four points using a Numeric Pain Scale (NPS) ranging from 0-10 at each point, with 0 corresponding to no pain and 10 being the worst possible pain.

    Measured: before surgery, and 3,6,9 and 12 months following hymenectomy

  2. Pressure-pain thresholds

    Pressure-pain thresholds will be obtained in four defined vestibular locations (2, 4, 8, and 10 o'clock) using a vulvar-algesiometer. The patient will be asked to report the point of initiation of pain while the examiner quantified the mechanical pain threshold. Higher algesiometer scores correspond to lower vestibular pain and a higher pain threshold.

    Measured: before surgery, and 3,6,9 and 12 months following hymenectomy

  3. Female sexual function index

    Change in female Sexual Function Index (FSFI): evaluating six different domains of sexual function: satisfaction, desire, lubrication, pain, arousal and orgasm

    Measured: before surgery, and 3,6,9 and 12 months following hymenectomy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Nov 2026
  2. Study start21 Jun 2024
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07913386
Sponsor's protocol ID
0673-23-HMO
Status last verified
Nov 2026
First submitted
27 Oct 2026
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Lev-Sagie A, Wertman O, Lavee Y, Granot M. Vestibular Anatomic Localization of Pain Sensitivity in Women with Insertional Dyspareunia: A Different Approach to Address the Variability of Painful Intercourse. J Clin Med. 2020 Jun 27;9(7):2023. doi: 10.3390/jcm9072023.

    PubMed 32605092

Questions about this trial

What is this clinical trial studying?

An observational study of Dyspareunia (Female), run by Hadassah Medical Organization at 1 site in Israel.

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 7 inclusion and 9 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 3 Nov 2026. 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 Israel. 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 Ahinoam Lev-Sagie, Prof. (972-54-3217178, levsagie@netvision.net.il), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improvement of dyspareunia (time frame: before surgery, and at 3,6,9 and 12 months following hymenectomy.). 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 NCT07913386, which also lists 1 linked publication.

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 3 Nov 2026; AzTrials last refreshed its copy on 3 Nov 2026.

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