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Effect of Multimodal Physical Therapy on Vaginismus Secondary to Chronic Constipation

3. listopadu 2026 aktualizováno: 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

Přehled studie

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

40

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Studijní místa

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

25 let až 35 let (Dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Ženský

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Aktivní komparátor: 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.

Experimentální: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Assessment of pain intensity
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Assessment of sexual function
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Vyšetřovatelé

  • Ředitel studie: Hossam H Kamel, Professor, Al-Azhar University
  • Studijní židle: Amel M Youssef, Professor, Cairo University

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. listopadu 2026

Primární dokončení (Odhadovaný)

20. května 2027

Dokončení studie (Odhadovaný)

31. května 2027

Termíny zápisu do studia

První předloženo

3. listopadu 2026

První předloženo, které splnilo kritéria kontroly kvality

3. listopadu 2026

První zveřejněno (Aktuální)

9. listopadu 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

9. listopadu 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

3. listopadu 2026

Naposledy ověřeno

1. listopadu 2026

Více informací

Termíny související s touto studií

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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