Effectiveness of DNS on Incontinence Severity, Pelvic Floor Strength and QoL in Urinary Incontinence

NCT06627452 | Completed

• 1 other identifier: _IstanbulUCdılanacar13579.....
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate the effects of Dynamic Neuromuscular Stabilization (DNS) Training on incontinence severity, pelvic floor muscle strength, and quality of life in women with Urinary Incontinence, compared to Pelvic Floor Muscle Training (PFMT). The hypothesis of the study is that DNS Training will be at least as effective as PFMT in terms of its impact on incontinence severity, pelvic floor muscle strength, and quality of life in women with Urinary Incontinence. A total of 56 women diagnosed with urinary incontinence will be included in the study. Participants will be divided into two groups: DNS and PFMT, and will engage in the designated exercise program 5 days a week for a total of 12 weeks. All participants will undergo an initial assessment before starting treatment, and a final assessment will be conducted by the same physiotherapist after the treatment.

Conditions

Urinary Incontinence , Stress; Urinary Incontinence (UI); Exercise

Keywords

dynamic neuromuscular stabilization; kegel exercise; urinary incontinence

Outcome Measures

Primary Outcomes (3)

• Incontinence Severity Index (ISI)

  Patients incontinence severity will be assessed using the Incontinence Severity Index (ISI). The index has two questions: 1) How often do you leak urine? (0=Never, 1=Less than once a month, 2=Once a month, 3=Several times a week, 4=Almost every day/night), and 2) How much urine do you leak? (0=None, 1=A few drops, 2=Small spots, 3=More). The result obtained from this index is the product of the two items that assess the frequency and amount of incontinence. The total score ranges from 1 to 12 and is categorized into four levels of incontinence severity: Mild (1 and 2 points), Moderate (3, 4, and 6 points), severe (8 and 9 points), and very severe (12 points).

  12 WEEKS

• 24-Hour Pad Test

  The pad test is one of the assessments that provide information about the severity of incontinence. One day before the examination, patients will be instructed to place a dry pad in their underwear after their first morning urination and continue their daily activities. They should change the pad every 4 to 6 hours to prevent evaporation and store the used pads in a sealed bag. Patients must bring all pads used until the next morning, along with a dry pad sample, for examination. The pads will be weighed on a sensitive scale to calculate the amount of urinary leakage. In the 24-hour pad test, values above 4 grams are considered significant, with incontinence severity classified as mild (≥4-20 grams/24 hours), moderate (21-74 grams/24 hours), and severe (≥75 grams/24 hours).

  12 WEEKS

• Urinary Diary

  A urinary diary is an assessment tool that records the frequency of urination, types and amounts of fluids consumed, and the frequency and severity of incontinence over a specified period. The recommended duration for keeping the diary is typically 1 to 7 days. A 3-day diary has been noted as an appropriate outcome measure for clinical studies evaluating stress incontinence treatments. Patients are advised not to change their usual urination habits or fluid intake while completing the diaries. A total of three diaries are collected from each patient and filled out on non-consecutive days. Patients are asked to record their urination times, the amount of urine produced, and their activities at the time of any leakage, including the corresponding times.

  12 WEEKS

Secondary Outcomes (2)

• Pelvic Floor Muscle Strength (PFMS)

  12 WEEKS

• Quality of Life Assessment

  12 WEEKS

Study Arms (2)

Study Group

EXPERIMENTAL

Participants in Dynamic Neuromuscular Stabilization(DNS) will perform exercises with a physiotherapist twice a week and at home three days a week. The sessions will last approximately 30 minutes and will be conducted five days a week for 12 weeks.

Other: Dynamic Neuromuscular Stabilization Training

Control Group

ACTIVE COMPARATOR

Participants in Pelvic Floor Muscle Training (PFMT) will be taught pelvic floor exercises through vaginal palpation. They will perform the exercises with a physiotherapist two days a week and at home three days a week. The sessions will last approximately 30 minutes and will be conducted five days a week for 12 weeks.

Other: Pelvic Floor Muscle Training

Interventions

Dynamic Neuromuscular Stabilization Training OTHER

Patients will be taught how to perform exercises in different developmental positions both manually and verbally by the DNS therapist. In the DNS concept, proper breathing patterns are important alongside stabilization, and elastic bands will be used to regulate intra-abdominal pressure (IAP) and teach correct breathing. The elastic band will be secured around the chest just below the ribcage, and the patient will be asked to expand the elastic band in all directions while inhaling, thereby regulating the IAP. After teaching IAP guidance, exercises will be conducted in developmental positions with IAP regulation. The exercises will be conducted twice a week under the supervision of a physiotherapist, and three days at home, with sessions lasting approximately 30 minutes, for a total of five days a week over a period of 12 weeks.

Study Group

Pelvic Floor Muscle Training OTHER

Pelvic floor exercises involving both slow and fast muscle contractions will be taught to patients through vaginal palpation. During fast contractions, patients will be instructed to quickly contract and relax their pelvic floor muscles. During slow contractions, patients will be asked to gradually squeeze their pelvic floor muscles, hold for 10 seconds, and then slowly relax. Each set of pelvic floor exercises will consist of 10 fast contractions and 10 slow contractions. Patients will perform pelvic floor exercises twice a week with a physiotherapist and three days at home. The exercises will be done in sets throughout the day, lasting approximately 30 minutes, and will be conducted over a period of 12 weeks.

Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of severity stress urinary incontinence based on symptoms
• Being literate
• Aged between 18 and 65
• Not having received any conservative treatment in the last 6 months.

You may not qualify if:

• Presence of prolapse
• Diagnosis of overactive bladder
• Ongoing urinary tract infection
• Use of medication for urinary incontinence
• Pregnancy
• Lack of cooperation for assessment and/or treatment
• Having undergone uro-surgical procedures within the last two years
• Patients with serious systemic diseases that would prevent them from exercising (such as cardiovascular disease, COPD, stroke, and/or cancer, etc.)

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress; Urinary Incontinence; Motor Activity

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Ayse Zengin Alpozgen, Assoc. Prof.

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

• Aycan Cakmak Reyhan, Asst. Prof.

  Istanbul Bilgi University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: October 2, 2024
• First Posted: October 4, 2024
• Study Start: September 30, 2024
• Primary Completion: May 30, 2025
• Study Completion: June 15, 2025
• Last Updated: August 7, 2025

Record last verified: 2024-09

Locations

TU (1)