Urinary IncontinenceNCT07858968
Pelvic Floor Rehabilitation Programme for Women With Urinary Incontinence in a Peruvian Public Hospital
A study testing Supervised group pelvic floor muscle training and Individual physiatrist-led pelvic floor sessions in people with Urinary Incontinence and Urinary Incontinence, Stress, run by Hospital Nacional Edgardo Rebagliati Martins at 1 site in Peru.
Trial summary
This study evaluates whether a 12-week pelvic floor rehabilitation programme improves urinary incontinence symptoms in adult women treated at Hospital Nacional Edgardo Rebagliati Martins, a public tertiary hospital in Lima, Peru. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Incontinence, Urinary Incontinence, Stress, Urinary Incontinence, Urge
- What is being tested?
- Supervised group pelvic floor muscle training and Individual physiatrist-led pelvic floor sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 sitePeru
- Study dates
- 3 Aug 2026to 31 Mar 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged 18 years or older, insured by EsSalud and treated at Hospital Nacional Edgardo Rebagliati Martins
- Urinary incontinence diagnosed by the Urology Service of the hospital
- Signed informed consent
Who cannot join
- Current pregnancy
- Urinary incontinence of documented neurological cause
- Pelvic organ prolapse stage II or higher (POP-Q)
- Severe cognitive impairment preventing active participation or completion of questionnaires
- Refusal to sign informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Pelvic Floor Rehabilitation Programme in Patients With Pelvic Floor Dysfunction Treated at Hospital Nacional Edgardo Rebagliati Martins: A Prospective Pre-Post Study
This study evaluates whether a 12-week pelvic floor rehabilitation programme improves urinary incontinence symptoms in adult women treated at Hospital Nacional Edgardo Rebagliati Martins, a public tertiary hospital in Lima, Peru. Women referred by the Urology Service attend supervised group pelvic floor muscle training with a physiotherapist, together with individual sessions with a physiatrist that may include EMG biofeedback, electrical stimulation, transcutaneous tibial nerve stimulation, myofascial techniques or bladder training. The main question is whether symptom severity, measured with the ICIQ-SF questionnaire, improves between baseline and week 12. Participants are followed for 6 months.
Read the detailed description
This single-arm, prospective pre-post study follows the TREND recommendations for nonrandomised evaluations. It includes two prespecified analytic populations. The full cohort is used to assess effectiveness, while a urodynamic subcohort, formed by participants with a prior urodynamic study classifying them as having urodynamic stress incontinence, detrusor overactivity or mixed incontinence, is used to explore whether urodynamic type predicts response.
Assessments take place at baseline, week 4, week 12 and 6 months. The primary analysis compares ICIQ-SF scores between baseline and week 12 using a paired t-test or Wilcoxon signed-rank test, depending on distribution. The planned sample size of 90 was calculated to detect a 3-point difference in the ICIQ-SF with 85% power and a two-sided alpha of 0.05, allowing for 15% attrition.
This study was registered retrospectively. Enrolment began on 3 August 2026 and closed on 9 September 2026, with 89 participants completing the baseline visit. The primary outcome and its analysis were defined in the ethics-approved protocol (version 1.2, 14 July 2026) before any week-12 data were collected. Perineometry and the Modified Oxford scale, originally planned at weeks 4 and 12, were withdrawn in September 2026 because of their dependence on the evaluator, and baseline values are reported descriptively only. All protocol changes were reported to the Ethics Committee.
- Conditions
- Urinary Incontinence, Urinary Incontinence, Stress, Urinary Incontinence, Urge, Mixed Urinary Incontinence
- Being tested
- Supervised group pelvic floor muscle training, Individual physiatrist-led pelvic floor sessions
- Keywords
- Pelvic floor muscle training, Pelvic floor rehabilitation, EMG biofeedback, Group exercise, Neuromuscular electrical stimulation, Transcutaneous tibial nerve stimulation, Bladder training, ICIQ-SF, Women, Peru
- Medical subject headings
- Urinary Incontinence, Urinary Incontinence, Stress, Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised group pelvic floor muscle trainingBehavioural
Group sessions of about 45 minutes led by a physiotherapist, three times a week for 12 weeks (36 sessions). The physiotherapist follows a specific, standardised protocol organised in three progressive phases of 12 sessions each, covering pelvic floor, trunk and breathing exercises without equipment or manual contact. Groups include approximately six participants
Individual physiatrist-led pelvic floor sessionsOther
Individual sessions delivered by the principal investigator. At every session, EMG biofeedback is used to show the patient how she contracts her pelvic floor, and she receives education tailored to the progress observed. Home exercises are not a standard set; they are individually prescribed and adjusted at each visit according to her progress, together with reinforcement of the exercises practised in the group sessions. Depending on clinical indication, sessions may also include surface electrical stimulation, transcutaneous tibial nerve stimulation, myofascial techniques or bladder training. Women with stress incontinence attend three sessions in month 1 and two per month thereafter, while those with urgency or mixed incontinence attend four sessions per month throughout.
| Study group | Role | What they receive |
|---|---|---|
| Pelvic floor rehabilitation programme | Experimental | Women with urinary incontinence receive a 12-week multimodal pelvic floor rehabilitation programme combining supervised group exercise, individual physiatrist-led sessions and a home exercise programme.
Interventions: Supervised group pelvic floor muscle training; Individual physiatrist-led pelvic floor sessions Receives: Behavioral: Supervised group pelvic floor muscle training; Other: Individual physiatrist-led pelvic floor sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ICIQ-SF total score
The International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) measures the frequency, amount and impact of urinary leakage. Scores range from 0 to 21, with higher scores indicating more severe symptoms. The change is calculated as the week-12 score minus the baseline score.
Measured: Baseline and week 12
Secondary outcomes (9)
Responders on the ICIQ-SF
Proportion of participants with a reduction of 3 or more points in the ICIQ-SF total score from baseline.
Measured: Week 12
ICIQ-SF total score over time
ICIQ-SF total score, range 0 to 21, with higher scores indicating more severe symptoms.
Measured: Baseline, week 4, week 12 and 6 months
Urine loss on the 1-hour pad test
Urine loss in grams on the 1-hour ICS pad test, and proportion of participants with less than 2 g.
Measured: Baseline and week 12
Urinary incontinence-related quality of life
Total score of a 10-item urinary quality-of-life questionnaire based on the ICIQ-LUTSqol, range 10 to 50, with higher scores indicating greater impact.
Measured: Baseline, week 12 and 6 months
Sexual function
Female Sexual Function Index total score in sexually active women, range 2 to 36, with lower scores indicating poorer function.
Measured: Baseline, week 12 and 6 months
Functioning and disability
WHODAS 2.0 12-item total score, range 0 to 48, with higher scores indicating greater limitation.
Measured: Baseline, week 12 and 6 months
Global impression of improvement
Proportion of participants rating themselves "very much better" or "much better" on the Patient Global Impression of Improvement.
Measured: Week 12
Prescription of bladder medication
Proportion of participants with an active prescription for an antimuscarinic or beta-3 agonist.
Measured: Baseline and 6 months
Perineal Pain Intensity Measured by Visual Analogue Scale (VAS)
Perineal pain intensity measured with a Visual Analogue Scale (VAS) ranging from 0 (no pain) to 10 (worst possible pain), with higher scores indicating more severe pain. Used as a safety measure.
Measured: Baseline, week 4 and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start3 Aug 2026
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Nacional Edgardo Rebagliati Martins
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Vigo Araujo, Hospital Nacional Edgardo Rebagliati Martins
- Investigators
- Laura Vigo Araujo, MD, Principal investigator, Hospital Nacional Edgardo Rebagliati Martins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07858968
- Sponsor's protocol ID
- HNERM-ERDSP-F2
- Other IDs
- 0553220260024952
- Status last verified
- Sep 2026
- First submitted
- 28 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are protected under Peruvian Law 29733 on Personal Data Protection, and the informed consent did not include sharing individual data with third parties. Only aggregated results will be published.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Pelvic Floor Rehabilitation Programme in Patients With Pelvic Floor Dysfunction Treated at Hospital Nacional Edgardo Rebagliati Martins: A Prospective Pre-Post Study
- ClinicalTrials.gov ID
- NCT07858968
- Acronym / sponsor ID
- HNERM-ERDSP-F2
- Conditions
- Urinary Incontinence, Urinary Incontinence, Stress, Urinary Incontinence, Urge, Mixed Urinary Incontinence
- Keywords
- Pelvic floor muscle training, Pelvic floor rehabilitation, EMG biofeedback, Group exercise, Neuromuscular electrical stimulation, Transcutaneous tibial nerve stimulation, Bladder training, ICIQ-SF
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Hospital Nacional Edgardo Rebagliati MartinsUniversity, hospital or other
- Study start
- 3 Aug 2026 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 5 Oct 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.
This study evaluates whether a 12-week pelvic floor rehabilitation programme improves urinary incontinence symptoms in adult women treated at Hospital Nacional Edgardo Rebagliati Martins, a public tertiary hospital in Lima, Peru. Women referred by the Urology Service attend supervised group pelvic floor muscle training with a physiotherapist, together with individual sessions with a physiatrist that may include EMG biofeedback, electrical stimulation, transcutaneous tibial nerve stimulation, myofascial techniques or bladder training. The main question is whether symptom severity, measured with the ICIQ-SF questionnaire, improves between baseline and week 12. Participants are followed for 6 months.
Detailed description
This single-arm, prospective pre-post study follows the TREND recommendations for nonrandomised evaluations. It includes two prespecified analytic populations. The full cohort is used to assess effectiveness, while a urodynamic subcohort, formed by participants with a prior urodynamic study classifying them as having urodynamic stress incontinence, detrusor overactivity or mixed incontinence, is used to explore whether urodynamic type predicts response.
Assessments take place at baseline, week 4, week 12 and 6 months. The primary analysis compares ICIQ-SF scores between baseline and week 12 using a paired t-test or Wilcoxon signed-rank test, depending on distribution. The planned sample size of 90 was calculated to detect a 3-point difference in the ICIQ-SF with 85% power and a two-sided alpha of 0.05, allowing for 15% attrition.
This study was registered retrospectively. Enrolment began on 3 August 2026 and closed on 9 September 2026, with 89 participants completing the baseline visit. The primary outcome and its analysis were defined in the ethics-approved protocol (version 1.2, 14 July 2026) before any week-12 data were collected. Perineometry and the Modified Oxford scale, originally planned at weeks 4 and 12, were withdrawn in September 2026 because of their dependence on the evaluator, and baseline values are reported descriptively only. All protocol changes were reported to the Ethics Committee.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pelvic floor rehabilitation programme | Experimental | Behavioral: Supervised group pelvic floor muscle training, Other: Individual physiatrist-led pelvic floor sessionsWomen with urinary incontinence receive a 12-week multimodal pelvic floor rehabilitation programme combining supervised group exercise, individual physiatrist-led sessions and a home exercise programme. Interventions: Supervised group pelvic floor muscle training; Individual physiatrist-led pelvic floor sessions |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women aged 18 years or older, insured by EsSalud and treated at Hospital Nacional Edgardo Rebagliati Martins
- Urinary incontinence diagnosed by the Urology Service of the hospital
- Signed informed consent
Key exclusion criteria (5 listed)
- Current pregnancy
- Urinary incontinence of documented neurological cause
- Pelvic organ prolapse stage II or higher (POP-Q)
- Severe cognitive impairment preventing active participation or completion of questionnaires
- Refusal to sign informed consent
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 |
|---|---|---|
| Supervised group pelvic floor muscle trainingGroup sessions of about 45 minutes led by a physiotherapist, three times a week for 12 weeks (36 sessions). The physiotherapist follows a specific, standardised protocol organised in three progressive phases of 12 sessions each, covering pelvic floor, trunk and breathing exercises without equipment or manual contact. Groups include approximately six participants | Behavioural | Pelvic floor rehabilitation programme |
| Individual physiatrist-led pelvic floor sessionsIndividual sessions delivered by the principal investigator. At every session, EMG biofeedback is used to show the patient how she contracts her pelvic floor, and she receives education tailored to the progress observed. Home exercises are not a standard set; they are individually prescribed and adjusted at each visit according to her progress, together with reinforcement of the exercises practised in the group sessions. Depending on clinical indication, sessions may also include surface electrical stimulation, transcutaneous tibial nerve stimulation, myofascial techniques or bladder training. Women with stress incontinence attend three sessions in month 1 and two per month thereafter, while those with urgency or mixed incontinence attend four sessions per month throughout. | Other | Pelvic floor rehabilitation programme |
Primary outcome
Change in ICIQ-SF total score
Time frame: Baseline and week 12
The International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) measures the frequency, amount and impact of urinary leakage. Scores range from 0 to 21, with higher scores indicating more severe symptoms. The change is calculated as the week-12 score minus the baseline score.
9 secondary outcomes
Responders on the ICIQ-SF
Time frame: Week 12
ICIQ-SF total score over time
Time frame: Baseline, week 4, week 12 and 6 months
Urine loss on the 1-hour pad test
Time frame: Baseline and week 12
Urinary incontinence-related quality of life
Time frame: Baseline, week 12 and 6 months
Sexual function
Time frame: Baseline, week 12 and 6 months
Functioning and disability
Time frame: Baseline, week 12 and 6 months
Global impression of improvement
Time frame: Week 12
Prescription of bladder medication
Time frame: Baseline and 6 months
Perineal Pain Intensity Measured by Visual Analogue Scale (VAS)
Time frame: Baseline, week 4 and week 12
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 5 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data are protected under Peruvian Law 29733 on Personal Data Protection, and the informed consent did not include sharing individual data with third parties. Only aggregated results will be published.
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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.
Laura Vigo Araujo, MD principal investigator
Hospital Nacional Edgardo Rebagliati Martins
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised group pelvic floor muscle training and Individual physiatrist-led pelvic floor sessions in people with Urinary Incontinence and Urinary Incontinence, Stress, run by Hospital Nacional Edgardo Rebagliati Martins at 1 site in Peru.
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 5 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: under way, not looking for participants, as of the sponsor's last update on 5 Oct 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 Peru. 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?
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?
Change in ICIQ-SF total score (time frame: Baseline and week 12). 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 2026.