Urinary IncontinenceNCT03500185
Effectiveness of Pelvic Floor Muscles Training in Group for Women With Urinary Incontinence
A study testing PFMT in group and PFMT at home in people with Urinary Incontinence, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
The aim of the study is to compare the efficacy of a protocol, pelvic floor muscle training (PFMT), applied in a group and at home for urinary incontinence (UI) in women. Probably, the group-applied PFMT protocol is more effective in women with UI than the home protocol. Read more about this study
- Who is it for?
- Ages 30 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- PFMT in group and PFMT at home
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteBrazil
- Study dates
- 17 Apr 2018to 30 Dec 2018
- 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 30 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be female;
- Have urinary incontinence;
- Between 30 and 70 years old;
- Have had sexual intercourse in the last 6 months;
- Participants should understand the instruments used in the research;
- Accept to participate in the study and sign the Term of Free and Informed Consent.
Who cannot join
- Have allergy to latex;
- Have performed or are undergoing pelvic radiotherapy;
- Be performing chemotherapy treatment;
- Women who delivered during the last 12 months;
- Have participated in individual or group PFMT in the last 6 months;
- Have contraction of the pelvic floor muscles grade zero (0).
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul
About this study
Official title: Effectiveness of Pelvic Floor Muscles Training in Group for Women With Urinary Incontinence: a Randomized Clinical Test
The aim of the study is to compare the efficacy of a protocol, pelvic floor muscle training (PFMT), applied in a group and at home for urinary incontinence (UI) in women. Probably, the group-applied PFMT protocol is more effective in women with UI than the home protocol.
Read the detailed description
Introduction: One of the female pelvic floor (PF) papers is to control urinary continence.
Changes in your PF function and structure can cause the dysfunction of the PF. Among these UI is more commonly reported and affects one-third of adult women and generates significant impact on the quality and life of these, including sexual activity. Among the possibilities to treat UI in a conservative manner, the PFMT should be recommended as an intervention of first-line treatment for women with such symptoms. Such training can be developed individually or in a group, just to be prescribed and performed 6-12 weeks to demonstrate such effectiveness. Nevertheless they are still scarce in the literature studies involving the PFMT, group and individual in application, that have validated and well-defined protocols and, in addition, protocols that are easy to understand and play by the patients.
Objective: The aim of the study is to compare the efficacy of a protocol of PFMT applied in a group and at home for UI in women.
Methodology: The study presents an experimental design type randomized blind clinical trial. The sample is not probabilistic for convenience, which shall contain the minimum number of 28 women in each group, obtained in the sample calculation. Women will be included from age 30 to 70 years who have had sexual intercourse in the last 12 months and who are able to understand the instruments, and sign the consent form. Women will be excluded with latex allergy, who have made treatment of pelvic radiotherapy, or are undergoing chemotherapy, women who had childbirth in the last 12 months which have participated in PFMT individually or in groups in the past six months. The assessment consists of a medical history form, which will include personal data; the evaluation of the function of PF is performed by the muscles pressure biofeedback apparatus which measures pressure peak contraction of the pelvic floor via a cuff connected to the pressure transducer; to assess the impact of UI on quality of life will use the International Consultation on Incontinence Questionnaire (ICIQ-SF); for evaluation of sexual function is used Pelvic Organ Prolapse Quiz / Urinary Incontinence Sexual Questionnaire (PISQ-12). Statistical analysis will be performed using the Shapiro-Wilk test to verify the normality of the data. Descriptive analysis of parametric data will be expressed as mean and standard deviation, and the nonparametric median and interquartile range. The qualitative variables are expressed as absolute and relative frequency. In the inferential analysis will be used for comparison of continuous variables parametric intragroup, ANOVA and non-parametric variables the Wilcoxon test. In the analysis of categorical variables will be used the McNemar test. As for the inferential analysis will be used for comparison of continuous variables parametric intergroup, ANOVA and non-parametric variables the Mann-Whitney test. In the analysis of categorical variables will be used chi-square test. For all analyzes will be of significance level of 5% (p ≤ 0.05).
- Conditions
- Urinary Incontinence
- Being tested
- PFMT in group, PFMT at home
- Keywords
- Physiotherapy, Pelvic floor, Urinary Incontinence
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PFMT in groupOther
Participants randomized to this group will perform the PFMT protocol in a group, with physiotherapeutic supervision, lasting 1 hour, in the Outpatient Clinic of Gynecology of Hospital of Clinics of Porto Alegre (HCPA), for a period of 3 months. You will also be instructed to perform exercises at home. After this period, they will be reassessed and will follow the same protocol for another 3 months now at home. After this period, they will be evaluated again.
PFMT at homeOther
Randomized participants for this group will receive guidance on the home PFMT protocol on the day of the initial evaluation. They will be instructed to perform the exercises daily for a period of 3 months. After 3 months they will be re-evaluated and will follow the same protocol for another 3 months at home. After this period they will be evaluated again.
| Study group | Role | What they receive |
|---|---|---|
| PFMT in group | Experimental | Participants randomized to this group will perform the PFMT protocol in a group, with physiotherapeutic supervision, lasting 1 hour, in the Outpatient Clinic of Gynecology of Hospital of Clinics of Porto Alegre (HCPA), for a period of 3 months. You will also be instructed to perform exercises at home. After this period, they will be reassessed and will follow the same protocol for another 3 months now at home. After this period, they will be evaluated again. Receives: Other: PFMT in group |
| PFMT at home | Active comparator | Randomized participants for this group will receive guidance on the home PFMT protocol on the day of the initial evaluation. They will be instructed to perform the exercises daily for a period of 3 months. After 3 months they will be re-evaluated and will follow the same protocol for another 3 months at home. After this period they will be evaluated again. Receives: Other: PFMT at home |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functionality of pelvic floor muscles
Capacity of voluntary contraction that reduces light and vaginal length, generating intravaginal pressure, in the case of this study evaluated by PERFECT Scale.
Measured: Evaluation after 24 weeks
Secondary outcomes (2)
Sexual function
A set of four successive stages: desire, arousal, orgasm and resolution, which have subjective, interpersonal, psychological, muscular and reflex characteristics, in the case of this study evaluated by the Pelvic Organ Prolapse / Urinary Incontinence Sexual Questionnaire (PISQ-12) .
Measured: Evaluation after 24 weeks
Quality of life in urinary incontinence
The presence of urinary incontinence causes a substantial and substantial negative impact on the quality of life of women living with this symptom. This impact on quality of life can be measured by the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF).
Measured: Evaluation after 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start17 Apr 2018
- Primary completion30 Dec 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary IncontinenceStudies 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
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- JOSÉ GERALDO LOPES RAMOS, Principal investigator, Federal University of Health Science of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03500185
- Sponsor's protocol ID
- 15-0316
- Status last verified
- Mar 2020
- First submitted
- 19 Oct 2017
- Last updated
- 6 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hay-Smith EJC, Starzec-Proserpio M, Moller B, Aldabe D, Cacciari L, Pitangui ACR, Vesentini G, Woodley SJ, Dumoulin C, Frawley HC, Jorge CH, Morin M, Wallace SA, Weatherall M. Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev. 2024 Dec 20;12(12):CD009508. doi: 10.1002/14651858.CD009508.pub2.
PubMed 39704322
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Pelvic Floor Muscles Training in Group for Women With Urinary Incontinence: a Randomized Clinical Test
- ClinicalTrials.gov ID
- NCT03500185
- Acronym / sponsor ID
- 15-0316
- Conditions
- Urinary Incontinence
- Keywords
- Physiotherapy, Pelvic floor, Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 17 Apr 2018 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 18 Apr 2018 (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 aim of the study is to compare the efficacy of a protocol, pelvic floor muscle training (PFMT), applied in a group and at home for urinary incontinence (UI) in women. Probably, the group-applied PFMT protocol is more effective in women with UI than the home protocol.
Detailed description
Introduction: One of the female pelvic floor (PF) papers is to control urinary continence.
Changes in your PF function and structure can cause the dysfunction of the PF. Among these UI is more commonly reported and affects one-third of adult women and generates significant impact on the quality and life of these, including sexual activity. Among the possibilities to treat UI in a conservative manner, the PFMT should be recommended as an intervention of first-line treatment for women with such symptoms. Such training can be developed individually or in a group, just to be prescribed and performed 6-12 weeks to demonstrate such effectiveness. Nevertheless they are still scarce in the literature studies involving the PFMT, group and individual in application, that have validated and well-defined protocols and, in addition, protocols that are easy to understand and play by the patients.
Objective: The aim of the study is to compare the efficacy of a protocol of PFMT applied in a group and at home for UI in women.
Methodology: The study presents an experimental design type randomized blind clinical trial. The sample is not probabilistic for convenience, which shall contain the minimum number of 28 women in each group, obtained in the sample calculation. Women will be included from age 30 to 70 years who have had sexual intercourse in the last 12 months and who are able to understand the instruments, and sign the consent form. Women will be excluded with latex allergy, who have made treatment of pelvic radiotherapy, or are undergoing chemotherapy, women who had childbirth in the last 12 months which have participated in PFMT individually or in groups in the past six months. The assessment consists of a medical history form, which will include personal data; the evaluation of the function of PF is performed by the muscles pressure biofeedback apparatus which measures pressure peak contraction of the pelvic floor via a cuff connected to the pressure transducer; to assess the impact of UI on quality of life will use the International Consultation on Incontinence Questionnaire (ICIQ-SF); for evaluation of sexual function is used Pelvic Organ Prolapse Quiz / Urinary Incontinence Sexual Questionnaire (PISQ-12). Statistical analysis will be performed using the Shapiro-Wilk test to verify the normality of the data. Descriptive analysis of parametric data will be expressed as mean and standard deviation, and the nonparametric median and interquartile range. The qualitative variables are expressed as absolute and relative frequency. In the inferential analysis will be used for comparison of continuous variables parametric intragroup, ANOVA and non-parametric variables the Wilcoxon test. In the analysis of categorical variables will be used the McNemar test. As for the inferential analysis will be used for comparison of continuous variables parametric intergroup, ANOVA and non-parametric variables the Mann-Whitney test. In the analysis of categorical variables will be used chi-square test. For all analyzes will be of significance level of 5% (p ≤ 0.05).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PFMT in group | Experimental | Other: PFMT in groupParticipants randomized to this group will perform the PFMT protocol in a group, with physiotherapeutic supervision, lasting 1 hour, in the Outpatient Clinic of Gynecology of Hospital of Clinics of Porto Alegre (HCPA), for a period of 3 months. You will also be instructed to perform exercises at home. After this period, they will be reassessed and will follow the same protocol for another 3 months now at home. After this period, they will be evaluated again. |
| PFMT at home | Active comparator | Other: PFMT at homeRandomized participants for this group will receive guidance on the home PFMT protocol on the day of the initial evaluation. They will be instructed to perform the exercises daily for a period of 3 months. After 3 months they will be re-evaluated and will follow the same protocol for another 3 months at home. After this period they will be evaluated again. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be female;
- Have urinary incontinence;
- Between 30 and 70 years old;
- Have had sexual intercourse in the last 6 months;
- Participants should understand the instruments used in the research;
Key exclusion criteria (6 listed)
- Have allergy to latex;
- Have performed or are undergoing pelvic radiotherapy;
- Be performing chemotherapy treatment;
- Women who delivered during the last 12 months;
- Have participated in individual or group PFMT in the last 6 months;
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 |
|---|---|---|
| PFMT in groupParticipants randomized to this group will perform the PFMT protocol in a group, with physiotherapeutic supervision, lasting 1 hour, in the Outpatient Clinic of Gynecology of Hospital of Clinics of Porto Alegre (HCPA), for a period of 3 months. You will also be instructed to perform exercises at home. After this period, they will be reassessed and will follow the same protocol for another 3 months now at home. After this period, they will be evaluated again. | Other | PFMT in group |
| PFMT at homeRandomized participants for this group will receive guidance on the home PFMT protocol on the day of the initial evaluation. They will be instructed to perform the exercises daily for a period of 3 months. After 3 months they will be re-evaluated and will follow the same protocol for another 3 months at home. After this period they will be evaluated again. | Other | PFMT at home |
Primary outcome
Functionality of pelvic floor muscles
Time frame: Evaluation after 24 weeks
Capacity of voluntary contraction that reduces light and vaginal length, generating intravaginal pressure, in the case of this study evaluated by PERFECT Scale.
2 secondary outcomes
Sexual function
Time frame: Evaluation after 24 weeks
Quality of life in urinary incontinence
Time frame: Evaluation after 24 weeks
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 6 Mar 2020.
- Derived from this study: PubMed 39704322Hay-Smith EJC, Starzec-Proserpio M, Moller B, Aldabe D, Cacciari L, Pitangui ACR, Vesentini G, Woodley SJ, Dumoulin C, Frawley HC, Jorge CH, Morin M, Wallace SA, Weatherall M. Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev. 2024 Dec 20;12(12):CD009508. doi: 10.1002/14651858.CD009508.pub2.
Related trials for Urinary Incontinence
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
Urinary Incontinence, Overactive Bladder Syndrome
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
Urinary Incontinence, Urge Incontinence
Active, not recruitingObservational study
Overactive Bladder Symptoms and Urinary Incontinence In Women With Rheumatoid Arthritis
Rheumatoid Arthritis, Rheumatoid Arthritis (RA)
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.
JOSÉ GERALDO LOPES RAMOS principal investigator
Federal University of Health Science of 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 PFMT in group and PFMT at home in people with Urinary Incontinence, 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 6 inclusion and 6 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 6 Mar 2020. 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. 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?
Functionality of pelvic floor muscles (time frame: Evaluation after 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03500185, which also lists 1 linked publication.
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 6 Mar 2020.