Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy (RETURN)

Background. Recommended periods of activity restriction after urogynaecological surgery vary between 2 and 12 weeks for the same procedure. Most existing data come from secondary analyses of trials or from retrospective questions asked months after surgery, which are prone to recall bias. In a secondary analysis of the TOMUS trial, fewer than half of women resumed normal activities within 2 weeks of a midurethral sling, and timing of return was not associated with treatment failure or adverse events. Randomised trials after midurethral sling and prolapse surgery found that shorter or liberal restrictions did not compromise outcomes and improved satisfaction. Prospective, real-time data on when women resume specific activities, what stops them, and how this differs between procedures are lacking, as are data from Central and Eastern Europe.

Objectives. Primary: to estimate the time to return to the pre-operative level of physical activity after retropubic midurethral sling and after laparoscopic sacrocolpopexy. Secondary: (1) to describe return to ten predefined everyday activities during the first 6 postoperative weeks; (2) to assess whether pain intensity in the first postoperative week predicts the pace of return; (3) to identify reasons for not resuming activity, distinguishing adherence to medical advice from fear of harming the surgical result; (4) to identify clinical factors associated with slower return; (5) to assess the quality of early recovery and satisfaction with treatment.

Design. Prospective, non-interventional, single-centre study with two parallel cohorts and follow-up to 6 months. Surgical indication, technique and postoperative advice follow routine practice and are not influenced by the study. Postoperative instructions are standardised within each cohort. Reporting will follow STROBE.

Data collection. The investigator completes a case report form from the medical record and routine examination (demographics, obstetric and surgical history, POP-Q, modified Oxford scale, intra-operative data, Clavien-Dindo complications, 30-day urinary tract infection and readmission). Participants complete questionnaires at scheduled routine visits and keep a home diary identified only by a study number. The diary contains a weekly activity card (ten activities: walking ≥30 min, light housework, yoga/Pilates/stretching, cycling, strenuous exercise, driving, paid work, lifting >5 kg, swimming, sexual intercourse; the last three from week 4), a pain card (NRS 0-10 daily on days 0-7, then weekly) and a card recording the date each activity was first performed.

Schedule.

At baseline, both cohorts complete IPAQ-SF, the Tegner activity scale and PFDI-20, and undergo POP-Q, ICIQ-UI SF and modified Oxford assessment. On postoperative day 1, both cohorts complete QoR-15. During weeks 1-6, participants keep the diary and complete IPAQ-SF weekly. At 6 weeks, both cohorts complete IPAQ-SF, Tegner, PFDI-20 and ICIQ-S; cohort A also completes ICIQ-UI SF, and cohort B undergoes POP-Q. At 3 months, cohort B completes IPAQ-SF and, if not fully returned to activity by week 6, the date card. At 6 months, the 6-week assessments are repeated in both cohorts.

Statistical analysis (proposed). Time to return will be analysed with Kaplan-Meier estimates per cohort, censoring participants who have not returned by the end of diary follow-up. The association of mean week-1 pain and clinical factors with time to return will be assessed with Cox proportional hazards models. Reasons for non-resumption will be summarised as proportions per activity and week. Questionnaire scores will be compared with baseline using mixed-effects models for repeated measures. The two cohorts are analysed descriptively side by side; they differ in indication and procedure and are not intended for causal comparison.

Ethics and data protection. Written informed consent is obtained before enrolment and may be withdrawn at any time without consequences for care. Data are pseudonymised at collection; the key linking study numbers to identities is held separately by the principal investigator. Results will be published in aggregate form only.