Bilateral Sacrospinous Colposuspension (BSC) in the Female Genital Prolapse With Urinary Urge Symptomatology

NCT03640364 | Unknown DMC

• 1 other identifier: HCR051631
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective non-randomised trial investigating the effect of vaginal vault Suspension on urge symptomatology in female patients with pelvic organ prolapse

Conditions

Urinary Urge Incontinence

Keywords

pelvic organ prolapse; incontinence; minimally invasive; vaginal surgery; macroporous; lightweight; mesh; polypropylene; POP; urge

Outcome Measures

Primary Outcomes (2)

• Influence of BSC placement on symptoms of urinary urge expressed by change in clinical examination

  The change in symptoms after the surgical intervention is evaluated by clinical examination . The clinical examination is descriptive, not quantitative and no units are applicable or reportable.

  Checked after 6 weeks, six months and twelve months

• Change in score of standardized ICIQ documentation

  The International Consultation on Incontinence Questionnaire is used to evaluate Change in Quality of life and urge symptomatology

  Checked after 6 weeks, six months and twelve months

Secondary Outcomes (1)

• Anatomical correction of female pelvic organ prolapse

  Checked after 6 weeks, six months and twelve months

Eligibility Criteria

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

Study Population

female patients with pelvic organ prolapse suffering from symptoms of urinary urge incontinence

You may qualify if:

• urge urinary incontinence or symptoms thereof
• years old or older
• Compliance regarding data collection, therapy and follow-up
• written informed consent
• simultaneous performance of surgical colporrhaphy permitted

You may not qualify if:

• pelvic organ prolapse without symptoms of urinary urge
• age less than 18 years
• no informed consent
• lack of compliance
• adverse reaction to polypropylene
• life expectancy less than anticipated duration of protocol
• ASA 4

Sponsors & Collaborators

• Helios Medical Center Schleswig: lead

Study Sites (1)

Helios Medical Center

Schleswig, 24837, Germany

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence, Urge; Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Urinary Incontinence; 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; Prolapse; Pathological Conditions, Anatomical

Study Officials

• Dirk G Kieback, MD,Ph.D

  Helios Medical Center Schleswig

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dirk G Kieback, MD, Ph.D

CONTACT

+49 4621 812; dirk.kieback@helios-gesundheit.de

Marek Volkmer, MD

CONTACT

+49 4621 812; marek.volkmer@helios-gesundheit.de

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Dept. of Obstetrics and Gynecology

Study Record Dates

• First Submitted: August 6, 2018
• First Posted: August 21, 2018
• Study Start: April 1, 2018
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2021
• Last Updated: August 21, 2018

Record last verified: 2018-08

Locations

DE (1)