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Status unknownNCT05666427Updated Jan 4, 2023

Investigation of the Effects of Stabilization Exercises and Pelvic Floor Muscle Training on Pain and Urinary Parameters in Individuals With Chronic Low Back Pain With Urinary Incontinence

An interventional study of Pelvic floor muscle training combined with stabilization exercises and Pelvic floor muscle training in Low Back Pain and Urinary Incontinence, sponsored by Hasan Kalyoncu University. Status unknown. Open to female participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-04.

Sponsored by Hasan Kalyoncu University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
Female
01

Study summary

The research will be done with people with urinary incontinence and low back pain. 3 groups of volunteer participants will be formed. The groups were planned as study group, classical application group and control group. Classical pelvic floor muscle training will be applied to the classical application group. Pelvic floor muscle training combined with stabilization exercises will be applied to the study group. In this study, the effect of pelvic floor muscle training combined with stabilization exercises on pain and urinary parameters compared to classical pelvic floor muscle training will be investigated in people with urinary incontinence and low back pain at the same time.

Read the detailed description

The rehabilitation period in the study was determined as 2 months. Participants will receive treatment with a supervisor 1 or 2 days a week. On other days, they will continue as a home program.

02

Conditions studied

  • Low Back Pain
  • Urinary Incontinence

Keywords

  • low back pain
  • Urinary Incontinence
  • pelvic floor muscle training
  • stabilization exercises
03

In context

Urinary Incontinence

1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.

This study's planned enrollment of 50 is below the median of 66 across 1,011 interventional studies indexed under Urinary Incontinence.

Browse Urinary Incontinence studies →

Lead sponsor

Hasan Kalyoncu University is the lead sponsor of 161 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Those with low back pain for at least 3 months (at least once a week with low back pain)
  • Those with urinary incontinence
  • 4 and above according to Numerical Pains Rating Scale
  • At least 20% according to the Oswestry Disability Index
  • Body Mass Index 30 and below

Exclusion criteria

Exclusion Criteria:

  • Those who have undergone lumbar or pelvic surgery in the last 6 months
  • Those who received pelvic floor muscle training in the last 3 months
  • Systemic, inflammatory, rheumatic, malignant, osseous pathologies etc. that may cause low back pain. those with diseases
  • Those who are pregnant
  • Stage 3-4 of pelvic organ prolapse
  • Those who are pregnant
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
50 participants (estimated)

Study arms

  • No intervention
    Control Group

    No application will be made until the end of this group work. After the end of the study, the effective protocol will be applied.

  • Active comparator
    Classic Application Group

    In this group, classical pelvic floor muscle training will be applied.

    Behavioral: Pelvic floor muscle training

  • Active comparator
    Study Group

    The protocol determined for the study will be applied in this group. This protocol is planned as follows: It will perform stabilization exercises with the activation of the pelvic floor muscles.

    Behavioral: Pelvic floor muscle training combined with stabilization exercises

Interventions

  • BehavioralPelvic floor muscle training combined with stabilization exercises

    While people are doing stabilization exercises, they will also work the pelvic floor muscles. Practices will be combined with breathing.

  • BehavioralPelvic floor muscle training

    Exercises that activate the pelvic floor muscles to strengthen and increase endurance.

06

What researchers measure

Primary outcomes

  1. Numerical Pain Rating Scale

    In a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10, 0 and 20 or 0 and 100 that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'

    Time frame: a day before rehabilitation

  2. Euro Quality of Life 5D-3L

    The EQ-5D-3L (European Quality of Life 5 Dimensions 3 Level Version) is a generic tool for Patient Reported Outcomes (PRO) measurement that can assess patients' quality of life, irrespective of the disease

    Time frame: a day before rehabilitation

  3. Incontinence Severity Index

    The incontinence severity index (ISI) consists of two questions, regarding frequency and amount of leakage. It categorizes urinary incontinence (UI) into slight, moderate, severe, and very severe.

    Time frame: a day before rehabilitation

Secondary outcomes

  1. Modified Oxford Scale

    The Modified Oxford Scale (MOS) was used to rate pelvic floor muscle contraction on a scale of 0-511: 0 = no contraction; 1 = minor muscle 'flicker'; 2 = weak muscle contraction; 3 = moderate muscle contraction; 4 = good muscle contraction and 5 = strong muscle contraction

    Time frame: a day before rehabilitation

  2. Tampa Kinesiophobia Scale

    The Tampa Scale of Kinesiophobia (TSK) that was developed in 1990 is a 17 item scale originally developed to measure the fear of movement related to chronic lower back pain.

    Time frame: a day before rehabilitation

  3. Oswestry Disability Index

    The Oswestry Disability Index (ODI) is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain.The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel.

    Time frame: a day before rehabilitation

  4. Pain Catastrophizing Scale

    Pain catastrophizing is characterized by the tendency to magnify the threat value of a pain stimulus and to feel helpless in the presence of pain, as well as by a relative inability to prevent or inhibit pain-related thoughts in anticipation of, during, or following a painful event.

    Time frame: a day before rehabilitation

  5. State-Trait Anxiety Inventory

    The State-Trait Anxiety Inventory (STAI) is a psychological inventory consisting of 40 self-report items on a 4-point Likert scale. The STAI measures two types of anxiety - state anxiety and trait anxiety. Higher scores are positively correlated with higher levels of anxiety. Its most current revision is Form Y and it is offered in more than 40 languages

    Time frame: a day before rehabilitation

  6. Incontinence Quality of Life Instrument

    The I-QOL has 22 questions with the following 3 subscales: avoid and limiting behaviors (items), psychosocial impacts (9 items), and social embarrassment (5 items). It is easily self-administered and takes about 5 minutes to complete.

    Time frame: a day before rehabilitation

  7. Urinary Distress Inventory

    The Urogenital Distress Inventory (UDI-6) is a validated 6-item questionnaire that assesses lower urinary tract symptoms, including incontinence, in women.

    Time frame: a day before rehabilitation

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 4, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05666427
Lead sponsor
Hasan Kalyoncu University
Responsible party
Ibrahim Kucukcan (Principal Investigator, Hasan Kalyoncu University) — Principal investigator
First posted
Dec 27, 2022
Start date
Jan 1, 2023 (estimated)
Primary completion
Mar 1, 2023 (estimated)
Completion
Apr 1, 2023 (estimated)
Last update
Jan 4, 2023

Study contacts

Ibrahim Kucukcan, PHD
Contact
pt.kucukcan@gmail.com
+905300351105
Yavuz Yakut, Professor
study director · Hasan Kalyoncu University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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