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Effect of Multimodal Physical Therapy on Vaginismus Secondary to Chronic Constipation

2026年11月3日 更新者:Sherine Khaled Ahmed、Cairo University

The purpose of this study is to investigate the effect of multimodal physical therapy on vaginismus secondary to chronic constipation

調査の概要

詳細な説明

Vaginismus is a female sexual dysfunction characterized by involuntary spasmodic contractions of pelvic floor muscle that hinder or prevent vaginal penetration. It affects approximately 5-7% of women worldwide, with a notably higher prevalence reported in Eastern countries.

Chronic constipation is defined as a functional bowel disorder characterized by reduced bowel movement frequency, hard stools, excessive straining, sensations of anorectal obstruction, digital facilitation, and feelings of incomplete evacuation. Increasing evidence suggests a strong association between chronic constipation and pelvic floor hypertonicity. Visceral manipulation (VM) has been proposed as an effective therapeutic intervention for constipation by restoring the mobility and resilience of peritoneal and visceral structures, thereby improving organ motion and functional coordination within the abdominal cavity.

Physical therapy plays a crucial role in the management of pelvic floor hypertonicity, as targeted interventions aimed at reducing muscle tone have been shown to alleviate pain and enhance sexual function.

Muscle energy technique (MET) represents a safe and effective manual therapy approach for managing pelvic discomfort and improving both contractile and non-contractile tissue elasticity. MET is widely utilized in musculoskeletal and pelvic rehabilitation and has demonstrated superior effectiveness compared to passive stretching in enhancing muscle extensibility through controlled isometric contractions.

Vaginal dilator therapy is a well-established conservative treatment modality that facilitates gradual desensitization and mechanical stretching of vaginal tissues, proving effective in the management of vaginismus, dyspareunia, vaginal stenosis, and adhesions.

Despite the established links between pelvic floor hypertonicity, constipation, and vaginismus, limited research has explored integrated treatment approaches addressing both pelvic floor and visceral dysfunctions simultaneously. Therefore, the present study is significant in order to introduces a novel multimodal physical therapy intervention for primary vaginismus associated with chronic constipation, incorporating VM, progressive pelvic floor muscle relaxation using MET, and vaginal dilators.

研究の種類

介入

入学 (推定)

40

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

25年~35年 (大人)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

女性

説明

Inclusion Criteria:

  • Newly married females, with regular menstrual periods, have an inability to allow vaginal penetration and failed vaginal intercourse (primary vaginismus).
  • They complain of chronic constipation in the form of functional obstruction due to dysfunction of pelvic floor muscle and anal sphincter (anismus), leading to difficulties in expel stool from the anorectum.
  • Their age ranges from 25 - 35 years old.
  • Their body mass index ranges from 20 - 25 Kg/m2.

Exclusion Criteria:

  • Congenital uterine anomalies.
  • Pelvic or abdominal surgeries
  • Circumcision.
  • Intrinsic pelvic pathology including endometriosis, acute or chronic pelvic inflammatory disease, cervicitis, benign or malignant gynecologic tumors or uterine pathology including adenomyosis or leiomyoma and postoperative adhesions, in addition to any form of infection including herpes virus
  • Lesions such anorectal ulcers, inflammation or malignancy.
  • Irregular or infrequent menstrual cycles.
  • Heavy menstrual bleeding (HMB).
  • Systemic diseases.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ:Conventional therapy group

The participants will receive 2 weeks of conventional program for vaginismus, including massage, stretching exercises, and relaxation texhnique.

The conventional program for vaginismus includes:

  1. Massaging and stretching exercise for adductor muscles, Piriformis, low back muscles and Hamstrings.
  2. Relaxation technique using diaphragmatic breathing exercise in coordination with pelvic floor muscle exercise for awareness and relaxation (contraction of pelvic floor muscles (PFM) with expiration and relaxation of PFM with deep inspiration).

It will be applied for two weeks.

実験的:Conventional and multimodal physiotherapy program group

The participants will receive 2 weeks of the same conventional treatment, in addition to visceral manipulation and progressive PFM relaxation technique.

The conventional program for vaginismus includes:

  1. Massaging and stretching exercise for adductor muscles, Piriformis, low back muscles and Hamstrings.
  2. Relaxation technique using diaphragmatic breathing exercise in coordination with pelvic floor muscle exercise for awareness and relaxation (contraction of pelvic floor muscles (PFM) with expiration and relaxation of PFM with deep inspiration).

It will be applied for two weeks.

It will be applied for two weeks. it includes:

  1. Visceral manipulation (VM) for colon release to treat constipation.
  2. Progressive pelvic floor muscle relaxation technique using muscle energy techniques combined with vaginal dilators.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Assessment of pain intensity
時間枠:2 weeks

Visual analogue scale (VAS) will be used to assess pain intensity. It is a popular tool for the measurement of pain; it will be used before and after treatment. It consists of a line usually 10 cm in length, it involves a 10 cm line where the left end indicates the absence of pain, and the right end indicates unbearable pain.

2 weeks

二次結果の測定

結果測定
メジャーの説明
時間枠
Assessment of sexual function
時間枠:2 weeks

The Female Sexual Function Index Scoring will be used to assess the female sexual function and diagnose female sexual dysfunction. Five factors or domains of sexual function were identified: (a) desire and subjective arousal, (b) lubrication, (c) orgasm, (d) satisfaction, and (e) pain/discomfort. It is a brief, multidimensional self-report instrument for assessing the key dimensions of sexual function in women. It is psychometrically sound, easy to administer, and has demonstrated ability to discriminate between clinical and nonclinical populations. The questionnaire described is designed and validated for assessment of female sexual function and quality of life in clinical trials or epidemiological studies

2 weeks
Assessment of constipation
時間枠:2 weeks

Knowles-Eccersley-Scott-Symptom Questionnaire (KESS) will be used to assess constipation. It is a modified version of the Cleveland Clinic Score questionnaire. A structured interviewer led questionnaire consisting of eleven questions. This questionnaire was designed to be simple enough to be completed in under five minutes. Each question had four or five possible answers which were scored on an unweighted linear integer scale to produce a range of between zero and three or zero and four points. Lower scores represented symptom- free states and higher scores, increased symptom severity. The total (KESS) score was the sum of all scores gained on individual questions with a maximum possible of 39 points.

2 weeks
Measurement of pressure pain threshold at trigger points in hypertonic muscles
時間枠:2 weeks

The pressure pain threshold at trigger points in hypertonic muscles will be evaluated by a pressure algometer. It is a device that is accurately assess trigger points. Muscles should be relaxed, algometer's tip is placed on the most sensitive point in perineum and adductors muscle at a 90° angle, and pressure is gradually increased until the patient verbally expresses discomfort. This process can be repeated multiple times, and the average of the determined values is recorded.

2 weeks
Assessment of cognitive and emotional responses related to vaginal penetration
時間枠:2 weeks

Vaginal Penetration Cognition Questionnaire (VPCQ) is a psychometric tool that will be used to assess cognitive and emotional responses specifically related to vaginal penetration.

It is a brief self-report measure of cognitions regarding vaginal penetration in women diagnosed with lifelong vaginismus and acquired/lifelong dyspareunia. Statistical analyses resulted in a 22-item simultaneous solution forming the five VPCQ subscales, respectively, (i) "control cognitions," (ii) "catastrophic and pain cognitions," (iii) "self-image cognitions," (iv) "positive cognitions," and (v) "genital incompatibility cognitions. Each item is scored on a 7-point Likert scale ranging from 0 (Not at all applicable / Never) to 6 (Very strongly applicable / Always).

2 weeks
Digital Rectal Examination Scoring System
時間枠:2 weeks

Digital rectal examinations (DREs) are a routine part of all general physical examinations and are particularly important in the evaluation of patients with disorders of defecation such as fecal incontinence and constipation. The Digital Rectal Examination Scoring System (DRESS) The system utilizes an analog scale of 0 to 5. During DRE, separate numbers are assigned to resting pressure (RP) and to maximal squeeze pressure (SQ). A score of 3 is normal. A resting score of 5 indicates very high pressures and a tight anal canal, whereas a score of 0 denotes an open or patulous anal canal at rest with separation of the buttocks. A squeeze score of 5 indicates a very strong squeeze, almost painful to the examiner, while a score of 0 denotes no discernable increase in pressure from rest with maximal patient effort.

2 weeks

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • スタディディレクター:Hossam H Kamel, Professor、Al-Azhar University
  • スタディチェア:Amel M Youssef, Professor、Cairo University

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年11月1日

一次修了 (推定)

2027年5月20日

研究の完了 (推定)

2027年5月31日

試験登録日

最初に提出

2026年11月3日

QC基準を満たした最初の提出物

2026年11月3日

最初の投稿 (実際)

2026年11月9日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月9日

QC基準を満たした最後の更新が送信されました

2026年11月3日

最終確認日

2026年11月1日

詳しくは

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医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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