- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07926399
Effect of Multimodal Physical Therapy on Vaginismus Secondary to Chronic Constipation
The purpose of this study is to investigate the effect of multimodal physical therapy on vaginismus secondary to chronic constipation
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Sherien K Ahmed, Master
- Telefonnummer: 01120030433
- E-post: Sherine.khaled.712@gmail.com
Studer Kontakt Backup
- Navn: Doaa A Osman, As.professor
- Telefonnummer: 0122314186
- E-post: Doaa.osman@cu.edu.eg
Studiesteder
-
-
-
Cairo, Egypt
- Cairo university
-
Ta kontakt med:
- Sherien K Ahmed, Master
- Telefonnummer: 01120030433
- E-post: Sherine.khaled.712@gmail.com
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / 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:
It will be applied for two weeks. |
|
Eksperimentell: 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:
It will be applied for two weeks. It will be applied for two weeks. it includes:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Assessment of pain intensity
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Assessment of sexual function
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Hossam H Kamel, Professor, Al-Azhar University
- Studiestol: Amel M Youssef, Professor, Cairo University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- P.T.REC/012/006456
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .