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

October 27, 2026 updated by: Aleksandra Piątek, Public Healthcare Centre of the Ministry of Interior and Administration

Return to Physical Activity and Early Recovery After Urogynaecological Surgery: a Prospective Observational Two-Cohort Study

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Wroclaw, Poland, 50-233
        • Department of Minimally Invasive Gynaecology with Pelvic Floor Disorders Centre, Public Healthcare Centre of the Ministry of Interior and Administration

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

  • Women aged 18 years or older
  • Scheduled for isolated retropubic midurethral sling (cohort A) or laparoscopic sacrocolpopexy with or without hysterectomy (cohort B)
  • Written informed consent
  • Able to complete questionnaires and keep the diary independently

Exclusion Criteria:

  • Pregnancy
  • Active malignancy under oncological treatment
  • Significant cognitive impairment preventing questionnaire completion
  • Neurological or orthopaedic conditions preventing independent walking before surgery
  • Cohort A only: concomitant pelvic floor or gynaecological procedure
  • Refusal or withdrawal of consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: OTHER
  • Time Perspectives: PROSPECTIVE

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort A: Retropubic midurethral sling

Women undergoing isolated retropubic midurethral sling (TVT) for stress or stress-predominant mixed urinary incontinence, without concomitant procedures.
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.
Cohort B: Laparoscopic sacrocolpopexy

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to return to the pre-operative level of physical activity
Time Frame: From surgery to 6 months

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.
From surgery to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first performance of each predefined activity
Time Frame: From surgery to 6 months.

Days from surgery to the first performance of each of ten everyday activities, recorded on the diary date card.
From surgery to 6 months.
Early postoperative pain as a predictor of return to activity
Time Frame: From surgery to 6 months.

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).
From surgery to 6 months.
Reasons for not performing activities.
Time Frame: Weeks 1-6

Proportion of coded reasons per activity and week, distinguishing adherence to medical advice from fear of harming the surgical result.
Weeks 1-6
Clinical factors associated with slower return to activity.
Time Frame: From surgery to 6 months.

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 .
From surgery to 6 months.
Quality of early recovery (QoR-15)
Time Frame: Postoperative day 1.

QoR-15 total score, 0-150 (higher = better recovery).
Postoperative day 1.
Satisfaction with treatment (ICIQ-S)
Time Frame: 6th week, 6th month.

ICIQ-S score; exploratory (working Polish translation).
6th week, 6th month.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Public Healthcare Centre of the Ministry of Interior and Administration

Collaborators

Wrocław University of Science and Technology
Wroclaw University of Health and Sport Sciences

Investigators

  • Principal Investigator: Aleksandra K. Piątek, MD, PhD, Department of Minimally Invasive Gynaecology with Pelvic Floor Disorders Centre, Public Healthcare Centre of the Ministry of Interior and Administration
  • Study Chair: Gabriela Kołodyńska, PhD, Department of Physiotherapy Basics and Occupational Therapy, Wroclaw University of Health and Sport Sciences (AWF Wrocław)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 21, 2026

Primary Completion (Estimated)

June 30, 2029

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

October 27, 2026

First Submitted That Met QC Criteria

October 27, 2026

First Posted (Actual)

November 3, 2026

Study Record Updates

Last Update Posted (Actual)

November 3, 2026

Last Update Submitted That Met QC Criteria

October 27, 2026

Last Verified

October 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RETURN-UROGYN-01
  • Bioethics Committee Consent (Other Identifier: Lower Silesian Medical Chamber)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Results will be published in aggregate form only. Participant consent and the data-protection basis (GDPR) do not cover sharing of individual-level data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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