VaginismusNCT07926399
Effect of Multimodal Physical Therapy on Vaginismus Secondary to Chronic Constipation
A study testing Conventional physiotherapy and Multimodal physical therapy program in people with Vaginismus and Chronic Constipation, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of this study is to investigate the effect of multimodal physical therapy on vaginismus secondary to chronic constipation Read more about this study
- Who is it for?
- Ages 25 to 35 years, women only
- Conditions the study is for
- Vaginismus, Chronic Constipation
- What is being tested?
- Conventional physiotherapy and Multimodal physical therapy program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2026to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Cairo university
Cairo
Sherien K Ahmed, Master, 01120030433, Sherine.khaled.712@gmail.com
About this study
The purpose of this study is to investigate the effect of multimodal physical therapy on vaginismus secondary to chronic constipation
Read the detailed description
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.
- Conditions
- Vaginismus, Chronic Constipation
- Being tested
- Conventional physiotherapy, Multimodal physical therapy program
- Medical subject headings
- Vaginismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional physiotherapyOther
The conventional program for vaginismus includes:
- Massaging and stretching exercise for adductor muscles, Piriformis, low back muscles and Hamstrings.
- 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.
Multimodal physical therapy programOther
It will be applied for two weeks. it includes:
- Visceral manipulation (VM) for colon release to treat constipation.
- Progressive pelvic floor muscle relaxation technique using muscle energy techniques combined with vaginal dilators.
| Study group | Role | What they receive |
|---|---|---|
| Conventional therapy group | Active comparator | The participants will receive 2 weeks of conventional program for vaginismus, including massage, stretching exercises, and relaxation texhnique. Receives: Other: Conventional physiotherapy |
| Conventional and multimodal physiotherapy program group | Experimental | The participants will receive 2 weeks of the same conventional treatment, in addition to visceral manipulation and progressive PFM relaxation technique. Receives: Other: Conventional physiotherapy; Other: Multimodal physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of pain intensity
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.
Measured: 2 weeks
Secondary outcomes (5)
Assessment of sexual function
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
Measured: 2 weeks
Assessment of constipation
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.
Measured: 2 weeks
Measurement of pressure pain threshold at trigger points in hypertonic muscles
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.
Measured: 2 weeks
Assessment of cognitive and emotional responses related to vaginal penetration
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).
Measured: 2 weeks
Digital Rectal Examination Scoring System
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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2026
- Study startNov 2026 (estimated)
- Primary completion20 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaginismusStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherine Khaled Ahmed, Cairo University
- Investigators
- Hossam H Kamel, Professor, Study director, Al-Azhar UniversityAmel M Youssef, Professor, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07926399
- Sponsor's protocol ID
- P.T.REC/012/006456
- Status last verified
- Nov 2026
- First submitted
- 3 Nov 2026
- Last updated
- 9 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Multimodal Physical Therapy on Vaginismus Secondary to Chronic Constipation
- ClinicalTrials.gov ID
- NCT07926399
- Acronym / sponsor ID
- P.T.REC/012/006456
- Conditions
- Vaginismus, Chronic Constipation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- 20 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 9 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the effect of multimodal physical therapy on vaginismus secondary to chronic constipation
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional therapy group | Active comparator | Other: Conventional physiotherapyThe participants will receive 2 weeks of conventional program for vaginismus, including massage, stretching exercises, and relaxation texhnique. |
| Conventional and multimodal physiotherapy program group | Experimental | Other: Conventional physiotherapy, Other: Multimodal physical therapy programThe participants will receive 2 weeks of the same conventional treatment, in addition to visceral manipulation and progressive PFM relaxation technique. |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional physiotherapyThe 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. | Other | Conventional and multimodal physiotherapy program group, Conventional therapy group |
| Multimodal physical therapy programIt 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. | Other | Conventional and multimodal physiotherapy program group |
Primary outcome
Assessment of pain intensity
Time frame: 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.
5 secondary outcomes
Assessment of sexual function
Time frame: 2 weeks
Assessment of constipation
Time frame: 2 weeks
Measurement of pressure pain threshold at trigger points in hypertonic muscles
Time frame: 2 weeks
Assessment of cognitive and emotional responses related to vaginal penetration
Time frame: 2 weeks
Digital Rectal Examination Scoring System
Time frame: 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hossam H Kamel, Professor study director
Al-Azhar University
Amel M Youssef, Professor study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional physiotherapy and Multimodal physical therapy program in people with Vaginismus and Chronic Constipation, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sherien K Ahmed, Master (01120030433, Sherine.khaled.712@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of pain intensity (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2026.