Pelvic Floor Rehabilitation Programme for Women With Urinary Incontinence in a Peruvian Public Hospital

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 Perineometry and the Modified Oxford scale, originally planned at weeks 4 and 12, were withdrawn in September 2026 because of their dependence on the evaluator, and baseline values are reported descriptively only.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.

• Supervised group pelvic floor muscle training (Behavioral): 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 sessions (Other): 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.

Primary outcomes

• Change in ICIQ-SF total score [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.

Secondary outcomes

• Responders on the ICIQ-SF [Week 12]: Proportion of participants with a reduction of 3 or more points in the ICIQ-SF total score from baseline.
• ICIQ-SF total score over time [Baseline, week 4, week 12 and 6 months]: ICIQ-SF total score, range 0 to 21, with higher scores indicating more severe symptoms.
• Urine loss on the 1-hour pad test [Baseline and week 12]: Urine loss in grams on the 1-hour ICS pad test, and proportion of participants with less than 2 g.
• Urinary incontinence-related quality of life [Baseline, week 12 and 6 months]: 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.
• Sexual function [Baseline, week 12 and 6 months]: Female Sexual Function Index total score in sexually active women, range 2 to 36, with lower scores indicating poorer function.
• Functioning and disability [Baseline, week 12 and 6 months]: WHODAS 2.0 12-item total score, range 0 to 48, with higher scores indicating greater limitation.
• Global impression of improvement [Week 12]: Proportion of participants rating themselves "very much better" or "much better" on the Patient Global Impression of Improvement.
• Prescription of bladder medication [Baseline and 6 months]: Proportion of participants with an active prescription for an antimuscarinic or beta-3 agonist.
• Perineal Pain Intensity Measured by Visual Analogue Scale (VAS) [Baseline, week 4 and week 12]: 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.

Other outcomes

• 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.]: Percentage of participants in the urodynamic subcohort whose International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-SF) total score decreased by 3 or more points from baseline to week 12, reported separately for each urodynamic diagnosis (urodynamic stress incontinence, detrusor overactivity, mixed urinary incontinence) according to IUGA/ICS terminology. The ICIQ-SF total score ranges from 0 to 21, with higher scores indicating more severe urinary incontinence. Urodynamic diagnosis is taken from the urodynamic study performed by the HNERM Urology Department before enrolment.

Sex: Female, ages: 18 Years to any

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

• Laura Vigo Araujo, MD, Principal investigator, Hospital Nacional Edgardo Rebagliati Martins