Pilot Study - Patient Education and Pelvic Strength Exercises in Elderly Women With Incontinence.

NCT03862326 | Completed

• 1 other identifier: N-20160049
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

It will be investigate if women with a diaper grant in Aalborg Municipality can reduce diaper size and thus costs for diapers in the municipality through meetings with a incontinence nurse and pelvic floor exercises.

Conditions

Urinary Incontinence

Outcome Measures

Primary Outcomes (2)

• Pelvic floor strength

  Change in pelvic floor strength measured through internal palpation with the use of oxford Scale (0-5, where 5 is the highest strength) but transferred to percentage and normalized to baseline values.

  Change compared to baseline after 12 week intervention

• Pelvic floor strength

  Change in pelvic floor strength measured through internal palpation with the use of oxford Scale (0-5, where 5 is the highest strength) but transferred to percentage and normalized to baseline values.

  Change compared to baseline 3 months after end of intervention.

Secondary Outcomes (2)

• Change in life quality - UDI-6

  after 12 weeks of exercise and 3 months follow-up

• Change in life quality IIQ-7

  after 12 weeks of exercise and 3 months follow-up

Study Arms (3)

Group Training

OTHER

Group Training of the women with incontinence - with 5-8 women in each group. This is also Usual Care

Behavioral: Exercise

Individual training

EXPERIMENTAL

Individual pelvic floor exercises one-to-one with the physiotherapist

Behavioral: Exercise

Individual training with biofeedback

EXPERIMENTAL

Individual pelvic floor exercises one-to-one with the physiotherapist but with ultrasound used as biofeedback, and to check if the women are contracting the right muscles.

Behavioral: Exercise

Interventions

Exercise BEHAVIORAL

From lying to sitting to active exercises with focus on the pelvic floor

Also known as: Behaviour

Group Training; Individual training; Individual training with biofeedback

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diaper grant
• Urinary incontinency Living in own home in Aalborg Municipality

You may not qualify if:

• Dementia Inability to transport herself to the training facility neurological diseases inability to understand Danish or bring a translator

Sponsors & Collaborators

• University College of Northern Denmark: lead
• Aalborg Municipality: collaborator

Study Sites (1)

Signe Refsgaard Bech

Aalborg, 9000, Denmark

Location

Related Publications (1)

• Hay-Smith EJC, Starzec-Proserpio M, Moller B, Aldabe D, Cacciari L, Pitangui ACR, Vesentini G, Woodley SJ, Dumoulin C, Frawley HC, Jorge CH, Morin M, Wallace SA, Weatherall M. Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev. 2024 Dec 20;12(12):CD009508. doi: 10.1002/14651858.CD009508.pub2.

  PMID: 39704322 DERIVED

MeSH Terms

Conditions

Urinary Incontinence

Interventions

Exercise; Cognitive Behavioral Therapy

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Signe R Bech, Phd

  University College of Northern Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The Investigator and outcome assessor did not know what treatment the indivdual women got.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pricipal Investigator

Model Details: 3 arms, one with group exercises, one with individual exercises and one with ), Individual exercises guided by ultrasonography imaging

Study Record Dates

• First Submitted: February 14, 2019
• First Posted: March 5, 2019
• Study Start: August 1, 2016
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: November 5, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)