Rigid Hymenal Ring as a Cause for Insertional Dyspareunia

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.

Study Overview

• Status: Recruiting
• Conditions: Dyspareunia (Female)
• Intervention / Treatment: Other: Hymenectomy

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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Ahinoam Lev-Sagie, Prof.; Phone Number: 972-54-3217178; Email: levsagie@netvision.net.il

Study Locations

• Israel
  • Jerusalem, Israel, 9765422
    • Recruiting
    • Hadassah Medical Center
    • Contact: Ahinoam Lev-Sagie, MD; Email: levsagie@netvision.net.il
    • Contact: Ahinoam Lev-Sagie, Prof.; Email: levsagie@netvision.net.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited from a vulvovaginal clinic.

Description

Inclusion Criteria:

1. Age 18-45
2. Pre-menopausal
3. Patient experience insertional dyspareunia
4. Self-reported sexual pain intensity ≥3 in the 0-10 Visual Analogue Scale (VAS) or complete avoidance of penetrative intercourse due to pain severity
5. 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.
6. ASA I or II
7. BMI<35

Exclusion Criteria:

Exclusion criteria

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

Study Plan

How is the study designed?

Design Details

• Observational Models: COHORT
• Time Perspectives: PROSPECTIVE

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with insertional dyspareunia caused by rigid hymen, undergoing hymenectomy.	Other: Hymenectomy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	before surgery, and at 3,6,9 and 12 months following hymenectomy.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	before surgery, and 3,6,9 and 12 months following hymenectomy
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.	before surgery, and 3,6,9 and 12 months following hymenectomy
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	before surgery, and 3,6,9 and 12 months following hymenectomy

Collaborators and Investigators

• Sponsor: Hadassah Medical Organization

Publications and helpful links

General 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.

Helpful Links

• <p>Related Info</p>

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2024
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: October 27, 2026
• First Submitted That Met QC Criteria: November 1, 2026
• First Posted (Actual): November 3, 2026

Study Record Updates

• Last Update Posted (Actual): November 3, 2026
• Last Update Submitted That Met QC Criteria: November 1, 2026
• Last Verified: November 1, 2026

More Information

Terms related to this study

• Keywords: Provoked vestibulodynia; hymen
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Mental Disorders; Genital Diseases, Male; Male Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Dyspareunia
• Other Study ID Numbers: 0673-23-HMO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No