DyspareuniaNCT02804048
Physiotherapy Intervention in Climacteric Women With Dyspareunia
A study testing superficial heat pelvic floor muscle, superficial heat low back and Pelvic Floor Muscle Training in people with Dyspareunia, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
Aim: To evaluate the effectiveness of physical therapy intervention techniques in the improvement of dyspareunia in climacteric women. Study design: This is a randomized controlled trial. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women only
- Conditions the study is for
- Dyspareunia
- What is being tested?
- superficial heat pelvic floor muscle, superficial heat low back and Pelvic Floor Muscle Training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2012to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- dyspareunia complaint for at least six months
- visual analog scale of pain above 3
- trophic vagina
Who cannot join
- vaginal atrophy
- neurological disorders
- lack of cognition and understanding
- urinary tract infection and / or genital infections
- prolapse grade 2 and 3
- severe systemic disease
- performing physical therapy
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Clinical Research Center of HCPA
Porto Alegre, Rio Grande do Sul, 900035-903
About this study
Official title: Physiotherapy Intervention in Climacteric Women With Dyspareunia: A Randomized Controlled Trial
Aim: To evaluate the effectiveness of physical therapy intervention techniques in the improvement of dyspareunia in climacteric women.
Study design: This is a randomized controlled trial.
Read the detailed description
Search location: Menopause and Sexuality Clinic of the department of obstetrics and Gynecology and Clinical Research Center, Hospital de Clínicas de Porto Alegre (HCPA).
Patients or participants: The recruited patients may not be vaginal atrophy (cytology-hormone test) and must provide the diagnosis of dyspareunia for more than six months being confirmed by one of the investigators through the pain score above grade 3 (visual analog pain scale) visual inspection, palpation and a questionnaire about the duration and location of pain.
Intervention and measures: consist of evaluation of the pelvic floor muscles (Oxford Scale and Perfect), myoelectric assessment (Electromyography), quality of life (Cervantes Scale), sexual function (FSFI), level of depression (Beck Scale) and pain (visual analog pain scale) before and after physical therapy intervention.
Expected results: To estimate the effectiveness of pelvic floor training techniques with physical therapy in women with dyspareunia.
- Conditions
- Dyspareunia
- Being tested
- superficial heat pelvic floor muscle, superficial heat low back, Pelvic Floor Muscle Training, Manual therapy in iliopsoas, diaphragm and piriformis, Intra Vaginal Manual therapy
- Keywords
- Dyspareunia, Pelvic floor muscles, Women
- Medical subject headings
- Dyspareunia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
superficial heat pelvic floor muscleOther
Superficial heat application in the pelvic floor muscle
superficial heat low backOther
Superficial heat application in the low back
Pelvic Floor Muscle TrainingOther
Pelvic floor muscle training exercises
Manual therapy in iliopsoas, diaphragm and piriformisOther
Manual therapy in iliopsoas, diaphragm and piriformis for 10 minutes
Intra Vaginal Manual therapyOther
Intra Vaginal Manual therapy in the pelvic floor muscles
Electromyographic biofeedbackOther
Electromyographic biofeedback in the pelvic floor muscles
| Study group | Role | What they receive |
|---|---|---|
| Pelvic Floor Muscle Training | Experimental | superficial heat pelvic floor muscle intra vaginal manual therapy. PERFECT scale is applied in 5 sessions and based on the result of each assessment is performed the treatment plan with exercises of the pelvic floor muscles.
It is performed manual therapy in iliopsoas, diaphragm and piriformis. From the fourth session, initiate treatment with electromyographic biofeedback based on the result of PERFECT scale. Receives: Other: superficial heat pelvic floor muscle; Other: Pelvic Floor Muscle Training; Other: Manual therapy in iliopsoas, diaphragm and piriformis; Other: Intra Vaginal Manual therapy; Other: Electromyographic biofeedback |
| Low back | Placebo comparator | superficial heat low back Manual therapy in piriform, lumbar, iliopsoas and diaphragm. Receives: Other: superficial heat low back; Other: Manual therapy in iliopsoas, diaphragm and piriformis |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effectiveness of physiotherapy techniques in pain improvement using visual analog scale pain
To evaluate the effectiveness of physiotherapy techniques using the analog pain scale.
Measured: Seven meetings, twice a week, in which the first is the initial assessment and the seventh is the final evaluation totaling a maximum of one month treatment for each patient.
Secondary outcomes (5)
To evaluate the quality of life
Measured: To evaluate the quality of life, using Cervantes Scale in climateric women in baseline and after four weeks of intervention
To evaluate depression
Measured: To evaluate depression, using Beck Scale, in baseline and after four weeks of intervention
To evaluate sexual function
Measured: To evaluate sexual function, using Female Sexual Function Index, in baseline and after four weeks of intervention
To evaluate electrical activity of the pelvic floor muscles
Measured: To evaluate electrical activity of the pelvic floor muscles, using Electromyographic biofeedback , in baseline and after four weeks of intervention
To evaluate the pelvic floor muscle function
Measured: To evaluate the pelvic floor muscle function, using PERFECT Scale in baseline and after four weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study startDec 2012
- Primary completionSep 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspareuniaStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe 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
- Participant
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Celeste Wender, PhD, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02804048
- Sponsor's protocol ID
- 13-0307
- Status last verified
- Oct 2016
- First submitted
- 12 Feb 2016
- Last updated
- 5 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiotherapy Intervention in Climacteric Women With Dyspareunia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02804048
- Acronym / sponsor ID
- 13-0307
- Conditions
- Dyspareunia
- Keywords
- Dyspareunia, Pelvic floor muscles, Women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Sep 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 17 Jun 2016 (estimated)
- 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.
Aim: To evaluate the effectiveness of physical therapy intervention techniques in the improvement of dyspareunia in climacteric women.
Study design: This is a randomized controlled trial.
Detailed description
Search location: Menopause and Sexuality Clinic of the department of obstetrics and Gynecology and Clinical Research Center, Hospital de Clínicas de Porto Alegre (HCPA).
Patients or participants: The recruited patients may not be vaginal atrophy (cytology-hormone test) and must provide the diagnosis of dyspareunia for more than six months being confirmed by one of the investigators through the pain score above grade 3 (visual analog pain scale) visual inspection, palpation and a questionnaire about the duration and location of pain.
Intervention and measures: consist of evaluation of the pelvic floor muscles (Oxford Scale and Perfect), myoelectric assessment (Electromyography), quality of life (Cervantes Scale), sexual function (FSFI), level of depression (Beck Scale) and pain (visual analog pain scale) before and after physical therapy intervention.
Expected results: To estimate the effectiveness of pelvic floor training techniques with physical therapy in women with dyspareunia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pelvic Floor Muscle Training | Experimental | Other: superficial heat pelvic floor muscle, Other: Pelvic Floor Muscle Training, Other: Manual therapy in iliopsoas, diaphragm and piriformis, Other: Intra Vaginal Manual therapy, Other: Electromyographic biofeedbacksuperficial heat pelvic floor muscle intra vaginal manual therapy. PERFECT scale is applied in 5 sessions and based on the result of each assessment is performed the treatment plan with exercises of the pelvic floor muscles. It is performed manual therapy in iliopsoas, diaphragm and piriformis. From the fourth session, initiate treatment with electromyographic biofeedback based on the result of PERFECT scale. |
| Low back | Placebo comparator | Other: superficial heat low back, Other: Manual therapy in iliopsoas, diaphragm and piriformissuperficial heat low back Manual therapy in piriform, lumbar, iliopsoas and diaphragm. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- dyspareunia complaint for at least six months
- visual analog scale of pain above 3
- trophic vagina
Key exclusion criteria (7 listed)
- vaginal atrophy
- neurological disorders
- lack of cognition and understanding
- urinary tract infection and / or genital infections
- prolapse grade 2 and 3
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 |
|---|---|---|
| superficial heat pelvic floor muscleSuperficial heat application in the pelvic floor muscle | Other | Pelvic Floor Muscle Training |
| superficial heat low backSuperficial heat application in the low back | Other | Low back |
| Pelvic Floor Muscle TrainingPelvic floor muscle training exercises | Other | Pelvic Floor Muscle Training |
| Manual therapy in iliopsoas, diaphragm and piriformisManual therapy in iliopsoas, diaphragm and piriformis for 10 minutes | Other | Low back, Pelvic Floor Muscle Training |
| Intra Vaginal Manual therapyIntra Vaginal Manual therapy in the pelvic floor muscles | Other | Pelvic Floor Muscle Training |
| Electromyographic biofeedbackElectromyographic biofeedback in the pelvic floor muscles | Other | Pelvic Floor Muscle Training |
Primary outcome
To evaluate the effectiveness of physiotherapy techniques in pain improvement using visual analog scale pain
Time frame: Seven meetings, twice a week, in which the first is the initial assessment and the seventh is the final evaluation totaling a maximum of one month treatment for each patient.
To evaluate the effectiveness of physiotherapy techniques using the analog pain scale.
5 secondary outcomes
To evaluate the quality of life
Time frame: To evaluate the quality of life, using Cervantes Scale in climateric women in baseline and after four weeks of intervention
To evaluate depression
Time frame: To evaluate depression, using Beck Scale, in baseline and after four weeks of intervention
To evaluate sexual function
Time frame: To evaluate sexual function, using Female Sexual Function Index, in baseline and after four weeks of intervention
To evaluate electrical activity of the pelvic floor muscles
Time frame: To evaluate electrical activity of the pelvic floor muscles, using Electromyographic biofeedback , in baseline and after four weeks of intervention
To evaluate the pelvic floor muscle function
Time frame: To evaluate the pelvic floor muscle function, using PERFECT Scale in baseline and after four weeks of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Dyspareunia
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
RecruitingObservational study
Rigid Hymenal Ring as a Cause for Insertional Dyspareunia
Dyspareunia (Female)
RecruitingPhase 2
Proof of Concept Study of Vaginal AZU-101 in Vulvovaginal Atrophy in Postmenopausal Women
Vulvo Vaginal Atrophy (VVA)
RecruitingObservational study
Association of Ultrasound Features of the Myometrium Suggestive of Adenomyosis and Clinical Symptoms
Adenomyosis of Uterus
Recruiting
F-GYN for Vaginal Dryness and Vulvovaginal Atrophy
Atrophic Vaginitis, Atrophic Vulvovaginitis
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. This study is not recruiting at the moment.
Maria Celeste Wender, PhD principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing superficial heat pelvic floor muscle, superficial heat low back and Pelvic Floor Muscle Training in people with Dyspareunia, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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 3 inclusion and 7 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: finished, as of the sponsor's last update on 5 Oct 2016. 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 Brazil. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the effectiveness of physiotherapy techniques in pain improvement using visual analog scale pain (time frame: Seven meetings, twice a week, in which the first is the initial assessment and the seventh is the final evaluation totaling a maximum of one month treatment for each patient.). 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 5 Oct 2016.