The Association Between Adenomyosis/Uterine Myoma and Lower Urinary Tract Symptoms

NCT02495311 | Unknown DMC

• 1 other identifier: 103129-F
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to assess the relationship between adenomyosis/myoma and lower urinary tract symptoms, sexual function and gastrointestinal symptoms.

Conditions

Adenomyosis; Uterine Leiomyoma

Keywords

adenomyosis; uterine myoma; lower urinary tract symptoms; sexual dysfunction; gastrointestinal symptom

Outcome Measures

Primary Outcomes (1)

• The corrleation coefficient between the size of myoma and Overactive Bladder Symptoms Scores

  The Spearman's correlation between the size of uterine myoma and the score of Overactive Bladder Symptoms Scores

  12 weeks

Secondary Outcomes (3)

• The corrleation coefficient between the size of myoma and the presence of constipation/diarrhea

  12 weeks

• Comparison of Overactive Bladder Symptoms Scores between the adenomyosis group and the control group

  12 weeks

• Comparisons of the constipation/diarrhea rates between the adenomyosis group and the control group

  12 weeks

Study Arms (3)

Women with uterine myoma

Women with uterine myoma

Procedure: myomectomy or adenomyomectomy

Women with adenomyosis

Women with adenomyosis

Procedure: myomectomy or adenomyomectomy

Women without uterine myoma or adenomyosis

Control group

Interventions

myomectomy or adenomyomectomy PROCEDURE

Women with adenomyosis; Women with uterine myoma

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women with uterine myoma or adenomyosis

You may qualify if:

• \>20 years old.
• Myoma: women with \>3 cm uterine myoma
• Adenomyosis: women with uterus having several dark area (lacunar areas) in one uterine wall or thickening uterine wall
• \<The control group\>
• \>20 years old.
• Women without myoma or adenomyosis
• \<Both groups\>

You may not qualify if:

• The patient has a lower urinary tract infection or acute intestinal inflammation.
• Previous surgery for the bladder or urethra.
• History of urinary tract stones or tumors.

Sponsors & Collaborators

• Far Eastern Memorial Hospital: lead

Study Sites (1)

Far-Eastern Memorial Hospital

Banqiao District, New Taipei, 22050, Taiwan

RECRUITING

MeSH Terms

Conditions

Adenomyosis; Myofibroma; Lower Urinary Tract Symptoms; Sexual Dysfunction, Physiological

Interventions

Uterine Myomectomy

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Gynecologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Sheng-Mou Hsiao, MD

  Department of Obstetrics & Gynecology, Far Eastern Memorial Hospital, Banqiao, New Taipei, Taiwan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheng-Mou Hsiao, MD

CONTACT

+89667000; smhsiao2@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Department of Obstetrics & Gynecology

Study Record Dates

• First Submitted: July 4, 2015
• First Posted: July 13, 2015
• Study Start: November 15, 2014
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: September 15, 2023

Record last verified: 2023-09

Locations

TW (1)