An observational study in Stress Urinary Incontinence and Pelvic Organ Prolapse, sponsored by Public Healthcare Centre of the Ministry of Interior and Administration. Active, not recruiting at 1 site in Poland. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Public Healthcare Centre of the Ministry of Interior and Administration · Observational
Advice on how long to limit physical activity after pelvic floor surgery ranges from 2 to 12 weeks and rests mainly on local tradition rather than data. This prospective observational study follows women undergoing a retropubic midurethral sling (TVT) for stress urinary incontinence or a laparoscopic sacrocolpopexy for pelvic organ prolapse at a single centre in Poland. For 6 weeks after surgery, participants keep a weekly diary of ten everyday activities, pain, and the reasons for not resuming each activity, and they complete validated questionnaires up to 6 months. The study does not change any aspect of treatment. Its main aim is to estimate the time to return to the pre-operative level of physical activity in each cohort.
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.
651 studies on the registry are indexed under Urinary Incontinence, Stress; 120 are open to participants now.
This study's planned enrollment of 200 is above the median of 130 across 127 observational studies indexed under Urinary Incontinence, Stress.
Browse Urinary Incontinence, Stress studies →This is the only study on the registry with Public Healthcare Centre of the Ministry of Interior and Administration as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Consecutive adult women scheduled for retropubic midurethral sling or laparoscopic sacrocolpopexy at the Department of Minimally Invasive Gynaecology, Public Healthcare Centre of the Ministry of Interior and Administration, Wrocław, Poland.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Women undergoing isolated retropubic midurethral sling (TVT) for stress or stress-predominant mixed urinary incontinence, without concomitant procedures.
Other: Questionnaire and Physical Exam
Women undergoing laparoscopic sacrocolpopexy for pelvic organ prolapse, with or without concomitant supracervical or total hysterectomy; other concomitant procedures are permitted and recorded.
Other: Questionnaire and Physical Exam
Surgical procedure performed as part of routine clinical care according to standard indications. The study does not influence the decision to operate, the surgical technique or postoperative advice. Patient-reported questionnaires - Validated Polish versions of IPAQ-SF, the Tegner activity scale, PFDI-20, QoR-15, ICIQ-S, ICIQ-UI SF. Completed at baseline, postoperative day 1, weekly to 6 weeks (IPAQ-SF), 6 weeks, 3 months (cohort B) and 6 months.
Time to return to the pre-operative level of physical activity
Days from surgery to the end of the first diary week in which the participant reports full return ("yes") to her usual pre-operative activity level.
Time frame: From surgery to 6 months
Time to first performance of each predefined activity
Days from surgery to the first performance of each of ten everyday activities, recorded on the diary date card.
Time frame: From surgery to 6 months.
Early postoperative pain as a predictor of return to activity
Association between mean pain intensity (NRS 0-10) on postoperative days 0-7 and time to return to the pre-operative activity level (hazard ratio).
Time frame: From surgery to 6 months.
Reasons for not performing activities.
Proportion of coded reasons per activity and week, distinguishing adherence to medical advice from fear of harming the surgical result.
Time frame: Weeks 1-6
Clinical factors associated with slower return to activity.
Association of baseline and perioperative characteristics (e.g. age, BMI, parity, baseline activity level, operative data, complications) with time to return to the pre-operative activity level .
Time frame: From surgery to 6 months.
Quality of early recovery (QoR-15)
QoR-15 total score, 0-150 (higher = better recovery).
Time frame: Postoperative day 1.
Satisfaction with treatment (ICIQ-S)
ICIQ-S score; exploratory (working Polish translation).
Time frame: 6th week, 6th month.
Plan to share: No — Results will be published in aggregate form only. Participant consent and the data-protection basis (GDPR) do not cover sharing of individual-level data.
Started Oct 2026 (actual). Primary completion is estimated for Jun 2029, 32 months after the start.
Of 39 non-industry observational studies under Urinary Incontinence, Stress, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 107. This study's planned 32 months is below that.
Counting every sponsor, half of 48 studies reached it within 45 months; a quarter within 18 and three quarters within 107.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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