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Rigid Hymenal Ring as a Cause for Insertional Dyspareunia

2026年11月1日 更新者:Ahinoam Lev-Sagie、Hadassah Medical Organization

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.

研究概览

地位

招聘中

详细说明

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.

研究类型

观察性的

注册 (估计的)

200

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 45年 (成人)

接受健康志愿者

不

有资格学习的性别

女性

取样方法

非概率样本

研究人群

Patients will be recruited from a vulvovaginal clinic.

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:COHORT
  • 时间观点:PROSPECTIVE

队列和干预

团体/队列
干预/治疗
Patients with insertional dyspareunia caused by rigid hymen, undergoing 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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Improvement of dyspareunia
大体时间:before surgery, and at 3,6,9 and 12 months following hymenectomy.

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.

次要结果测量

结果测量
措施说明
大体时间
Change in vestibular tenderness.
大体时间:before surgery, and 3,6,9 and 12 months following hymenectomy

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
大体时间:before surgery, and 3,6,9 and 12 months following hymenectomy

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
大体时间:before surgery, and 3,6,9 and 12 months following hymenectomy

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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年6月21日

初级完成 (估计的)

2028年12月1日

研究完成 (估计的)

2028年12月1日

研究注册日期

首次提交

2026年10月27日

首先提交符合 QC 标准的

2026年11月1日

首次发布 (实际的)

2026年11月3日

研究记录更新

最后更新发布 (实际的)

2026年11月3日

上次提交的符合 QC 标准的更新

2026年11月1日

最后验证

2026年11月1日

更多信息

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不

研究美国 FDA 监管的设备产品

不

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