- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02138487
Restricted Convalescence: Outcomes Following Urogynecologic Procedures (ReCOUP)
2 juni 2020 uppdaterad av: Kimberly Kenton, Northwestern University
The investigators are conducting a study to better understand the relationship between activity restrictions and women's satisfaction following urogynecologic surgery for prolapse.
We hypothesize that women with less stringent postoperative restrictions will have higher levels of satisfaction 12 weeks following surgery with no difference in respect to anatomic outcome.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Pelvic floor disorders (PFD) dramatically affect millions of women's quality of life (QOL), and 30% of American women will undergo reconstructive surgery for urinary incontinence or pelvic organ prolapse to improve bothersome symptoms and quality of life.
Surgical goals of women with PFD is often to resume their normal activities, which they have limited secondary to bothersome symptoms.
Yet, traditionally surgeons placed strict postoperative restrictions on patient's activity levels for 3 months; sometimes even recommending life long lifting and activity restrictions.
Activity restrictions are imposed on the premise that exercise can "weaken" surgical healing; however, emerging data from other fields suggests that increased activity may actually promote the healing process.
We aim to determine whether satisfaction, recovery, and anatomic outcomes after surgery are related to type of postoperative activity recommendations (liberal versus restricted).
Women having surgery for PFD will be randomized to receive either liberal or restricted postoperative activity recommendations and satisfaction, symptoms, QOL and anatomic outcomes will be measured after surgery.
We hypothesize that women with liberal activity recommendations will recover more quickly and report higher satisfaction and QOL, have fewer symptoms, and have similar anatomic outcomes to women with restricted activity restrictions.
These data will change paradigms of women's health and recovery after surgery.
Studietyp
Interventionell
Inskrivning (Faktisk)
105
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Illinois
-
Chicago, Illinois, Förenta staterna, 60637
- University of Chicago
-
Chicago, Illinois, Förenta staterna, 60611
- Northwestern University, Feinberg School of Medicine
-
-
Virginia
-
Roanoke, Virginia, Förenta staterna, 24016
- Virginia Tech Carilion School of Medicine
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Kvinna
Beskrivning
Inclusion Criteria:
- Ambulatory women undergoing surgical management of pelvic organ prolapse
- Prolapse > to Stage II on POP-Q
- Age >18 yrs
- Completed childbearing
- All subjects must have given signed, informed consent prior to registration on study
- All subjects must be able to read and complete study documents
Exclusion Criteria:
- Wheelchair-bound women
- Women with neurologic disease (Multiple Sclerosis, Parkinson's Disease)
- Abdominal approach with laparotomy
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Restricted postoperative activity
Women in the "restricted postoperative activity" group must abstain from exercise and heavy lifting for 3 months postoperatively
|
Women in this group will be given instructions regarding postoperative activity and will need to abstain from heavy lifting, running, aerobics for 3 months.
|
|
Experimentell: Liberal postoperative activity
Women in the "liberal postoperative activity" group will be allowed to resume their normal activities without restriction.
|
Women will be given specific instructions regarding postoperative activities and will not have any limitations regarding activity.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Satisfaction
Tidsram: 12 weeks following surgery
|
Satisfaction will be assessed following reconstructive pelvic surgery for prolapse using a question which assesses a patient's global impression.
Specifically, patients will be asked the question "how satisfied are you with your prolapse surgery?" at 12 wks to assess overall satisfaction.
Possible responses include "completely satisfied," "mostly satisfied," "neutral," "mostly dissatisfied," and "completely dissatisfied."
|
12 weeks following surgery
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Anatomic Outcomes
Tidsram: 12 weeks and 1 year following surgery
|
Anatomic outcomes will be assessed on physical examination 12 weeks and 1-year following reconstructive pelvic surgery.
|
12 weeks and 1 year following surgery
|
|
Quality of Life
Tidsram: 12 weeks and 1 year following surgery
|
Quality of life will be assessed using several validated questionnaires at 12 weeks and 1 year following reconstructive pelvic surgery for prolapse.
|
12 weeks and 1 year following surgery
|
|
Pain
Tidsram: 12 weeks and 1 year following surgery
|
Pain will be assessed using a visual analog scale at 12 weeks and 1 year following reconstructive pelvic surgery.
|
12 weeks and 1 year following surgery
|
|
Activity level
Tidsram: 12 weeks and 1 year
|
Activity level will be assessed using a validated questionnaire at 12 weeks and 1 year following reconstructive pelvic surgery.
|
12 weeks and 1 year
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Kimberly Kenton, MD, Northwestern University
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Mueller MG, Collins SA, Lewicky-Gaupp C, Tavathia M, Kenton K. Restricted Convalescence Following Urogynecologic Procedures: 1-Year Outcomes From a Randomized Controlled Study. Female Pelvic Med Reconstr Surg. 2021 Feb 1;27(2):e336-e341. doi: 10.1097/SPV.0000000000000922.
- Bochenska K, Hall E, Griffith JW, Kenton K, Alverdy A, Lewicky-Gaupp C, Mueller M. The Promise of PROMIS in Pelvic Organ Prolapse. Female Pelvic Med Reconstr Surg. 2019 Nov-Dec;25(6):426-429. doi: 10.1097/SPV.0000000000000685.
- Mueller MG, Lewicky-Gaupp C, Collins SA, Abernethy MG, Alverdy A, Kenton K. Activity Restriction Recommendations and Outcomes After Reconstructive Pelvic Surgery: A Randomized Controlled Trial. Obstet Gynecol. 2017 Apr;129(4):608-614. doi: 10.1097/AOG.0000000000001924.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 augusti 2014
Primärt slutförande (Faktisk)
1 januari 2020
Avslutad studie (Faktisk)
1 januari 2020
Studieregistreringsdatum
Först inskickad
8 maj 2014
Först inskickad som uppfyllde QC-kriterierna
13 maj 2014
Första postat (Uppskatta)
14 maj 2014
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
4 juni 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
2 juni 2020
Senast verifierad
1 juni 2020
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- STU00084995
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .