Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

Effect of Multimodal Physical Therapy on Vaginismus Secondary to Chronic Constipation

3 november 2026 uppdaterad av: 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

Studieöversikt

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

40

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

25 år till 35 år (Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Kvinna

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: 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.

Experimentell: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Assessment of pain intensity
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Assessment of sexual function
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Studierektor: Hossam H Kamel, Professor, Al-Azhar University
  • Studiestol: Amel M Youssef, Professor, Cairo University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 november 2026

Primärt slutförande (Beräknad)

20 maj 2027

Avslutad studie (Beräknad)

31 maj 2027

Studieregistreringsdatum

Först inskickad

3 november 2026

Först inskickad som uppfyllde QC-kriterierna

3 november 2026

Första postat (Faktisk)

9 november 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

9 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

3 november 2026

Senast verifierad

1 november 2026

Mer information

Termer relaterade till denna studie

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera