- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06578221
The Effect of Kegel Pelvic Floor Muscle Exercises on Urinary Retention, Pain, and Comfort Levels in Patients After Lumbar Disc Herniation Surgery: A Randomized Controlled Clinical Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
Postoperative urinary retention is the inability to urinate despite having a full bladder after surgery. It is a relatively common complication of both outpatient and inpatient procedures. Most cases are transient and are managed by temporarily emptying the bladder with bladder catheterization.
Studies in the literature report that transient postoperative urinary retention is common after cervical and lumbar spine surgery procedures. This situation is of great importance in terms of healthcare services, as it can increase both the length of hospital stay and the cost.
Kegel pelvic floor muscle exercises involve the repeated contraction and relaxation of the muscles that form part of the pelvic floor. With these exercises, pelvic floor blood circulation can be increased, pelvic floor muscle tension can be increased, and the contraction of the relaxed bladder can be stimulated indirectly by repeated contraction and relaxation of the pelvic floor muscles, and urine output can be achieved. Therefore, we think that these exercises, which are safe, cost-effective exercises that can be easily applied by healthcare personnel, and patient comfort among nursing practices to improve perioperative results and functional status, will have an effect in preventing urinary retention.
There are no experimental studies in the literature evaluating the effect of Kegel exercises applied after lumbar disc herniation surgery on urinary retention. Therefore, this study was planned to be conducted in patients who will undergo lumbar disc herniation surgery.
This study was planned as a single-center prospective randomized controlled experimental study. After obtaining verbal and written consent from the patients before surgery, the study will be conducted with various data collection forms.
These forms; Patient Information Form, Postoperative Data Collection Form, Numeric Rating Scale (NRS) to determine the pain level of the patients and Visual Analog Scale (VAS) to evaluate the comfort level. Patients will be randomized. Group I will be the Kegel pelvic floor muscle exercise group (n=29), Group II will be the control group (n=29). It is planned to measure the urinary retention and comfort levels of both groups in the postoperative period.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
University of Health Sciences
-
Ankara, University of Health Sciences, Turkey (Türkiye)
- Büşra Demirci
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Agreeing to participate in the study
- Over 18 years of age
- No communication barrier
- Having undergone lumbar disc herniation surgery under general anesthesia
- Being immobile for the first 8 hours postoperatively
- Not having a urinary catheter inserted during the intraoperative period
Exclusion Criteria:
- Refusal to participate in the study
- Previous urinary disorders/symptoms (such as Benign Prostatic Hyperplasia)
- Spinal trauma, preoperative neurological disorder
- Patients with preoperative catheterization
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Kegel Pelvic Floor Muscle Exercise Group
Kegel exercises will be performed by the researcher within the first 8 hours after being taken to the clinic room to perform the Kegel pelvic floor muscle exercises while in the supine position.
Urinary retention and comfort level of patients will be evaluated after surgery.
|
After the surgery, the patients will be taken to the clinic room in a supine position and the researcher will perform the Kegel pelvic floor muscle exercises three times at the 1st, 4th and 7th hours within the first 8 hours after the patients are taken to the clinic room.
|
|
No Intervention: Control Group
Urinary retention and comfort level of patients will be evaluated after surgery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effect of Kegel pelvic floor muscle exercises on urinary retention of patients after lumbar disc herniation surgery.
Time Frame: After completing Kegel pelvic floor muscle exercises in the first 8 hours after surgery.
|
Kegel pelvic floor muscle exercises will affect the urinary retention of patients after lumbar disc herniation surgery.
Urinary retention will be evaluated using the Postoperative Data Collection Form developed by the researchers based on the literature.
This form includes items assessing signs and symptoms of urinary retention within the first 8 hours postoperatively, such as pressure in the lower abdomen, pain in the lower abdomen, feeling of restlessness, and desire to urinate within 8 hours.
Each symptom is assessed separately using the Visual Analog Scale (VAS).
|
After completing Kegel pelvic floor muscle exercises in the first 8 hours after surgery.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effect of Kegel pelvic floor muscle exercises on comfort level after lumbar disc herniation surgery
Time Frame: After completing Kegel pelvic floor muscle exercises in the first 8 hours after surgery.
|
Kegel pelvic floor muscle exercises will affect comfort level of patients after lumbar disc herniation surgery.
The comfort level of the patients will be evaluated with VAS.
VAS is used to convert some unmeasurable values into numerical values.
VAS is a horizontal line with a length of 10 cm.
According to VAS, 0 is the lowest level and 10 is the highest level.
Patients will be asked to mark these levels on the 10 cm line.
|
After completing Kegel pelvic floor muscle exercises in the first 8 hours after surgery.
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Boonstra AM, Schiphorst Preuper HR, Reneman MF, Posthumus JB, Stewart RE. Reliability and validity of the visual analogue scale for disability in patients with chronic musculoskeletal pain. Int J Rehabil Res. 2008 Jun;31(2):165-9. doi: 10.1097/MRR.0b013e3282fc0f93.
- Wang R, Tunitsky-Bitton E. Short-term catheter management options for urinary retention following pelvic surgery: a cost analysis. Am J Obstet Gynecol. 2022 Jan;226(1):102.e1-102.e9. doi: 10.1016/j.ajog.2021.07.025. Epub 2021 Aug 5.
- Altschul D, Kobets A, Nakhla J, Jada A, Nasser R, Kinon MD, Yassari R, Houten J. Postoperative urinary retention in patients undergoing elective spinal surgery. J Neurosurg Spine. 2017 Feb;26(2):229-234. doi: 10.3171/2016.8.SPINE151371. Epub 2016 Oct 21.
- Aiyer SN, Kumar A, Shetty AP, Kanna RM, Rajasekaran S. Factors Influencing Postoperative Urinary Retention Following Elective Posterior Lumbar Spine Surgery: A Prospective Study. Asian Spine J. 2018 Dec;12(6):1100-1105. doi: 10.31616/asj.2018.12.6.1100. Epub 2018 Oct 16.
- Boulis NM, Mian FS, Rodriguez D, Cho E, Hoff JT. Urinary retention following routine neurosurgical spine procedures. Surg Neurol. 2001 Jan;55(1):23-7; discussion 27-8. doi: 10.1016/s0090-3019(01)00331-7.
- Huang BY, Leslie SW. Postoperative Urinary Retention. 2026 Feb 15. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK549844/
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15151515
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Surgery
-
MedtronicCompletedThoracic Surgery | Spine Surgery | Upper Extremity Surgery | Lower Extremity Surgery | Intracranial Surgery | Extracranial Surgery | Intratemporal Surgery | Extratemporal Surgery | Neck SurgeryGermany
-
[Redacted]3M; Solventum US LLCWithheldAbdominal Surgery | Orthopedic Surgery | Vascular Surgery | Cardiovascular SurgeryUnited States
-
Vanderbilt UniversityCompletedHand Surgery | Wrist Surgery | Forearm Surgery | Elbow SurgeryUnited States
-
Nantes University HospitalCompletedGynecological Surgery | Plastic Surgery | ENT SurgeryFrance
-
Baylor Research InstituteChiesi USA, Inc.CompletedSurgery | Cardiac Surgery | Surgery--Complications | Percutaneous Coronary InterventionUnited States
-
Maquet Cardiopulmonary GmbHNAMSATerminatedCardiac Surgery | Cardiopulmonary Bypass | Thoracic Surgery | Vascular SurgerySpain, Italy
-
Vanderbilt UniversityEdwards LifesciencesCompletedCardiac Surgery | Thoracic Surgery | Heart Surgery | Heart Transplant
-
Edwards LifesciencesCompletedAbdominal Surgery | Pelvic Surgery | Non-Cardiac/ Non-Thoracic Surgery | Major Peripheral Vascular SurgeryUnited States
-
Centre Hospitalier Universitaire de NīmesNot yet recruitingAnesthesia, Local | Foot Surgery | Hand Surgery | Walant SurgeryFrance
-
Eurosets S.r.l.RecruitingCardiac Surgery | Cardiopulmonary Bypass | Heart Surgery | Aortic Valve Surgery | Cannulation | Coronary Surgery With Cardiopulmonary Bypass | Coronary Surgery | Arterial Cannulation | Venous CannulationItaly
Clinical Trials on Kegel Pelvic Floor Muscle Exercise Group
-
sahra sultan karaActive, not recruitingSexual Dysfunctions, Psychological | Urinary Dysfunction | Vaginal Prolapse | Cystocele and Incomplete Uterovaginal Prolapse | Kegel Exercises | Sexual Function ScoresTurkey
-
Centre Hospitalier Universitaire de la RéunionInstitut National de la Santé Et de la Recherche Médicale, France; CIC-EC RéunionCompletedUrinary Incontinence | Anal Incontinence | Genital ProlapseFrance
-
City, University of LondonMedical University of ViennaCompleted
-
Delta University for Science and TechnologyCompletedPelvic Floor Myofascial PainEgypt
-
Shaanxi Hospital of Traditional Chinese MedicineMinistry of Science and Technology of the People´s Republic of ChinaUnknown
-
Indonesia UniversityCompleted
-
Taipei Medical University WanFang HospitalUnknown
-
YI-JU TSAIWithdrawn
-
Wake Forest University Health SciencesNational Institute on Aging (NIA)Completed
-
Istanbul University - Cerrahpasa (IUC)Completed