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
Sponsor study identifier
Secondary identifiers
OTHER · Ethics Committee of Hospital Nacional Edgardo Rebagliati Martins
interventional
89
1 country
1
Study Start
August 3, 2026
Actual (reported)Primary Completion
November 30, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 3, 2026
Actual (reported)September 28, 2026
Actual (reported)October 5, 2026
Actual (reported)November 30, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
March 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Baseline and week 12
Responders on the ICIQ-SF
Week 12
ICIQ-SF total score over time
Baseline, week 4, week 12 and 6 months
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
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
Hospital Nacional Edgardo Rebagliati Martins
Lima, Lima Province, Peru
Laura Vigo Araujo, MD
Hospital Nacional Edgardo Rebagliati Martins
89 participants (actual enrollment reported by the registry).
First Submitted
September 28, 2026
First Posted
October 5, 2026
Study Start
August 3, 2026
Actual (reported)Urine loss on the 1-hour pad test
Baseline and week 12
Urinary incontinence-related quality of life
Baseline, week 12 and 6 months
Sexual function
Baseline, week 12 and 6 months
Percentage of Participants With a Reduction of 3 or More Points in ICIQ-SF Score at Week 12, by Urodynamic Diagnosis
Baseline and week 12.
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.
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Primary Completion
November 30, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 5, 2026
Record last verified: 2026-09
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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Source: ClinicalTrials.gov.
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