Urinary IncontinenceNCT03514147
Pelvic Floor Muscle Training on the Quality of Life in Women With Urinary Incontinence
A study testing Experimental in people with Urinary Incontinence and Quality of Life, run by Hospital de Clinicas de Porto Alegre.
Trial summary
Aim: To assess the influence of pelvic floor muscles group training in the quality of life and functionality of these muscles in women with UI. Study design: This is a randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence, Quality of Life
- What is being tested?
- Experimental
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Jul 2017
- 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 18 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female;
- Have urinary incontinence;
- Age between 35 and 70 years;
- Have 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
- Latex allergy;
- 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 MAP training in the last 6 months;
- Have contraction of the pelvic floor muscles grade zero (0).
About this study
Official title: The Effect of Pelvic Floor Muscle Training on the Quality of Life and Functionality in Women With Urinary Incontinence: a Randomized Controlled Trial
Aim: To assess the influence of pelvic floor muscles group training in the quality of life and functionality of these muscles in women with UI.
Study design: This is a randomized controlled trial.
Read the detailed description
Search location: Urogynecology Ambulatory Care of Porto Alegre Clinical Hospital (HCPA)
Patients or participants: Women will be included in aged 35-70 years who have had sexual intercourse in the last 12 months and who are able to understand the instruments, besides signing an informed consent form. Women will be excluded with latex allergy, who have made pelvic radiotherapy, or be undergoing chemotherapy, puerperal a year, or who use antidepressants and / or anxiolytics.
Intervention and measures: The evaluation consists of a medical history form, which will include personal data; the assessment of the MAP function is performed by the pressure biofeedback; for assessment of quality of life will use the questionnaire ICQI-SF and sexual function the PISQ-12 before and after Pelvic Floor Muscle Training.
Expected results: To estimate effectiveness of Pelvic Floor Muscle Training in the quality of life and functionality of these muscles in women with urinary incontinence.
- Conditions
- Urinary Incontinence, Quality of Life
- Being tested
- Experimental, Control
- Keywords
- Women, Pelvic Floor Muscles
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalOther
Also called Pelvic Floor Muscle Training in group
- Profile of participants: an anamnesis file was used to collect personal data;
- To evaluate the quality of life: To evaluate the quality of life, using International Consultation on Incontinence Questionnaire (ICIQ-Short form) in women with urinary incontinence in baseline and after 12 weeks of intervention;
- To evaluate the pelvic floor muscle functionality: To evaluate the pelvic floor muscle functionality, using PERFECT Scale and Pressure Biofeedback in baseline and after 12 weeks of intervention;
ControlOther
Also called Pelvic Floor at Home
- Profile of participants: an anamnesis file was used to collect personal data;
- To evaluate the quality of life: To evaluate the quality of life, using International Consultation on Incontinence Questionnaire (ICIQ-Short form) in women with urinary incontinence in baseline and after 12 weeks of intervention;
- To evaluate the pelvic floor muscle functionality: To evaluate the pelvic floor muscle functionality, using PERFECT Scale and Pressure Biofeedback in baseline and after 12 weeks of intervention;
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Pelvic Floor Muscle Training in group. Exercise Protocol: The exercise group was supervised and met for 1 hour, one time per week, for 12 weeks. Participants were instructed to perform their respective daily exercises. Receives: Other: Experimental |
| Control | Active comparator | Pelvic Floor Muscle Training in home Exercise Protocol:The same exercise were performed at home for 12 weeks, without supervision. Participants were instructed to perform their respective daily exercises. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life in women with urinary incontinence
International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) - scored between 0 and 21.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2018
- Study startOct 2015
- Primary completionJul 2017
- Study completionJul 2017
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
- Investigator
- 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, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03514147
- Sponsor's protocol ID
- 15-0271
- Status last verified
- Apr 2018
- First submitted
- 20 Apr 2018
- Last updated
- 2 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pelvic Floor Muscle Training on the Quality of Life and Functionality in Women With Urinary Incontinence: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03514147
- Acronym / sponsor ID
- 15-0271
- Conditions
- Urinary Incontinence, Quality of Life
- Keywords
- Women, Pelvic Floor Muscles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Oct 2015 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 2 May 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.
Aim: To assess the influence of pelvic floor muscles group training in the quality of life and functionality of these muscles in women with UI.
Study design: This is a randomized controlled trial.
Detailed description
Search location: Urogynecology Ambulatory Care of Porto Alegre Clinical Hospital (HCPA)
Patients or participants: Women will be included in aged 35-70 years who have had sexual intercourse in the last 12 months and who are able to understand the instruments, besides signing an informed consent form. Women will be excluded with latex allergy, who have made pelvic radiotherapy, or be undergoing chemotherapy, puerperal a year, or who use antidepressants and / or anxiolytics.
Intervention and measures: The evaluation consists of a medical history form, which will include personal data; the assessment of the MAP function is performed by the pressure biofeedback; for assessment of quality of life will use the questionnaire ICQI-SF and sexual function the PISQ-12 before and after Pelvic Floor Muscle Training.
Expected results: To estimate effectiveness of Pelvic Floor Muscle Training in the quality of life and functionality of these muscles in women with urinary incontinence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: ExperimentalPelvic Floor Muscle Training in group. Exercise Protocol: The exercise group was supervised and met for 1 hour, one time per week, for 12 weeks. Participants were instructed to perform their respective daily exercises. |
| Control | Active comparator | Other: ControlPelvic Floor Muscle Training in home Exercise Protocol:The same exercise were performed at home for 12 weeks, without supervision. Participants were instructed to perform their respective daily exercises. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female;
- Have urinary incontinence;
- Age between 35 and 70 years;
- Have sexual intercourse in the last 6 months;
- Participants should understand the instruments used in the research;
Key exclusion criteria (6 listed)
- Latex allergy;
- 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 MAP training 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 |
|---|---|---|
| ExperimentalAlso: Pelvic Floor Muscle Training in group1. Profile of participants: an anamnesis file was used to collect personal data; 2. To evaluate the quality of life: To evaluate the quality of life, using International Consultation on Incontinence Questionnaire (ICIQ-Short form) in women with urinary incontinence in baseline and after 12 weeks of intervention; 3. To evaluate the pelvic floor muscle functionality: To evaluate the pelvic floor muscle functionality, using PERFECT Scale and Pressure Biofeedback in baseline and after 12 weeks of intervention; | Other | Experimental |
| ControlAlso: Pelvic Floor at Home1. Profile of participants: an anamnesis file was used to collect personal data; 2. To evaluate the quality of life: To evaluate the quality of life, using International Consultation on Incontinence Questionnaire (ICIQ-Short form) in women with urinary incontinence in baseline and after 12 weeks of intervention; 3. To evaluate the pelvic floor muscle functionality: To evaluate the pelvic floor muscle functionality, using PERFECT Scale and Pressure Biofeedback in baseline and after 12 weeks of intervention; | Other | Control |
Primary outcome
Quality of life in women with urinary incontinence
Time frame: 12 weeks
International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) - scored between 0 and 21.
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 2 May 2018.
- 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.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
José Geraldo Lopes Ramos principal investigator
Hospital de Clinicas de Porto Alegre
Questions about this trial
What is this clinical trial studying?
A study testing Experimental in people with Urinary Incontinence and Quality of Life, run by Hospital de Clinicas de Porto Alegre.
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 2 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Quality of life in women with urinary incontinence (time frame: 12 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 NCT03514147, 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 2 May 2018.